Improving surgical care HERNIA

ABDOMINALWALL

HERNIAImproving surgical care

Marijn Poelman

ABD

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proving surgical care M

arijn Poelman

Uitnodiging

Voor het bijwonen van de openbare verdediging van mijn proefschrift getiteld

Abdominal Wall Hernia

Improving surgical care

Op vrijdag 26 september 2014 om 13.45 uur in de Aula van

de Vrije Universiteit.De Boelelaan 1105,

1081 HV in Amsterdam.

Receptie na afloop ter plaatse

Promovenda:Marijn Poelman

Gerard Brandtstraat 3-41054JH Amsterdam

[email protected]

Paranimfen:Maartje Poelman

[email protected] Bors

[email protected]

De pdf van het proefschrift is te downloaden op:

www.inchtrial.nl

ABDOMINAL WALL HERNIA


Marijn Poelman

Title: ABDOMINAL WALL HERNIA, improving surgical care

Dissertation, Vrije Universiteit, Amsterdam, the Netherlands

ISBN 978-94-6108-706-5

Layout and printed by Gildeprint - Enschede

The printing of this thesis was financially supported by:

ABN AMRO/ Chipsoft/ Covidien/ ChirurgenNoordWest.nl/ Dutch Hernia Society/ Foreest instituut

Alkmaar/ Vrije Universiteit Amsterdam/ Bard Nederland/ Olympus Nederland BV/ Nederlandse

Vereniging voor Endoscopische Chirurgie/ Nederlandse Vereniging voor Gastroenterologie

Copyright © M. Poelman, 2014. All rights reserved. No part of this publication may be reproduced.

VRIJE UNIVERSITEIT

ABDOMINAL WALL HERNIA


ACADEMISCH PROEFSCHRIFT

ter verkrijging van de graad Doctor aan

de Vrije Universiteit Amsterdam,

op gezag van de rector magnificus

prof.dr. F.A. van der Duyn Schouten,

in het openbaar te verdedigen

ten overstaan van de promotiecommissie

van de Faculteit der Geneeskunde

op vrijdag 26 september 2014 om 13.45 uur

in de aula van de universiteit,

De Boelelaan 1105

door

Marie Marijn Poelman

geboren te Groningen

promotor: prof.dr. H.J. Bonjer

copromotor: dr. W.H. Schreurs

Promotiecommissie

Overige leden: prof.dr. M.A. Cuesta, VUMC Amsterdam, Nederland

prof.dr. J. Jeekel, Erasmus MC, Rotterdam

prof.dr. H. Van Goor, Radboudumc, Nijmegen

prof.dr. G. Kazemier, VUMC Amsterdam

prof.dr. J. Lange, Erasmus MC Rotterdam

dr. B.J. Dwars, Slotervaartziekenhuis Amsterdam

drs. B.L.A.M. Langenhorst, Medisch Centrum Alkmaar

Contents

Chapter 1 General introduction and outline of this thesis 9

Part 1 Incisional hernia

Chapter 2 Modified onlay technique for the repair of the more complicated 21

incisional hernias: single-centre evaluation of a large cohort.

Hernia. 2010 Aug;14(4):369-74.

Chapter 3 Health-related quality of life in patients treated for incisional hernia 33

with an onlay technique.

Hernia. 2010 Jun;14(3):237-42.

Chapter 4 Open abdomen treatment: planned ventral hernia or delayed fascial 45

closure? A review of the literature compared with daily practice.

Submitted.

Chapter 5 The INCH-trial: A multicenter randomized controlled trial comparing 57

the cost-effectiveness of conventional open surgery and laparoscopic

surgery for incisional hernia repair.

BMC Surgery 2013 13:18 (7 June 2013).

Chapter 6 Comparison of the Dutch and English version of the Carolinas Comfort 69

Scale; a specific quality of life-questionnaire for abdominal hernia repairs

with mesh.

Hernia 2013 Oct 29.

Chapter 7 Laparoscopic incisional hernia repair: Influence of surgical technique on 85

recurrence rate. A systematic review of the literature.

Submitted.

Part 2 Groin hernia

Chapter 8 EAES Consensus Development Conference on endoscopic repair of 103

groin hernias.

Surg Endosc. 2013 Oct;27(10):3505-19.

Chapter 9 Summary and Discussion 133

Chapter 10 Nederlandse samenvatting 145

Dankwoord 149

Curriculum Vitae 155

Chapter 1

General introduction and outline of this thesis

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10 | Chapter 1

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General introduction and outline of this thesis | 11

1The abdominal wall

The abdominal wall serves many functions such as stabilization and movements of the trunk,

containment of the viscera and respiration. Adaptation of the abdominal wall to accommodate

increasing intra-abdominal volume due pregnancy, obesity or ascites is another distinct feature of

the abdominal wall. The strength of the abdominal muscles decreases with age due to reduced

activity and degeneration. Decrease of muscle volume and tone results in enlargement of pre-

existent hernias of the abdominal wall. The groin, the umbilicus and the hiatus of the diaphragm

are sites of predilection for hernia formation. Incomplete fusion of tissues during embryologic

development causes epigastric, above the umbilicus, or hypogastric, below the umbilicus,

hernias. The intersections of the different layers of the abdominal wall muscles predispose to the

development of rare hernias such as Petit and Grynfeltt hernias. Groin hernias, particularly those

cranially to the iliopubic ligament are the most common hernias. Annually, more than 25,000

patients with inguinal hernias undergo surgical repairs in the Netherlands.

These congenital hernias, hernias due to ageing together with hernias arising due to impaired

healing of incisions of the abdominal wall, i.e. incisional hernias, constitue the entire spectrum of

hernias of the abdominal wall. The optimal management of abdominal wall hernias has remained

unresolved despite the fact that the first hernia repairs occurred more than two centuries ago.

Incisional hernias

Incisional hernias are defects of the fascia of the abdominal wall, which can only develop after

abdominal surgery. Bulging of abdominal contents through the scar is visible and palpable when

patients are standing or coughing. These hernias occur in at least 10-15% of patients within

10 years after open abdominal surgery (1). Incisional hernias may be asymptomatic, but are

frequently associated with pain or discomfort. Strangulation of herniated bowel is the most

concerning consequence of an incisional hernia. Incisional hernias affect the quality of life and

economic productivity of patients (2).

Pre-disposing factors for developing an incisional hernia are obesity and post-operative surgical

site infections (3). The pathogenesis of incisional hernias is multifactorial. Altered collagen

metabolism and extra-cellular matrix disorders are important contributory factors (4).

When considering the ingenious design of the abdominal wall, one would suppose that repair

of abdominal wall hernias is complicated. Nevertheless, abdominal wall surgery is generally not

considered very challenging.

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12 | Chapter 1

Incisional hernia repair

Over 100,000 laparotomies are performed annually in the Netherlands, more than 10,000 of these

patients will develop an incisional hernia. Eighty percent of all patients with an incisional hernia

undergo surgical repair (5). The natural course of an incisional hernia is unknown. It is unclear

whether surgery should be recommended to asymptomatic patients to prevent obstruction or

strangulation of the bowel. Thirty-three to seventy-eight percent of the patient with an incisional

hernia are reported to become symptomatic over time (6,7). The only way to resolve this disease

is to repair the hernia surgically.

The aim of an incisional hernia repair is to reestablish the function of the abdominal wall; the

barrier between viscera and the external environment, the muscular function and the cosmesis of

the abdominal wall should be restored. Before the introduction of synthetic meshes to reinforce

the abdominal wall, repairs of incisional hernias were done by primary suture repairs. Recurrence

rates of suture repairs, particularly in larger defects, were high at long-term follow up. With

the introduction of prosthetic meshes at the end of the nineteenth century, recurrence rates

significantly dropped below 15% (8). However, the perfect solution for restoring all abdominal

wall functions has not yet been found. Because “mesh repair” is the best available surgical

technique so far, it is considered the gold standard. However, the surgical procedure to perform

this “mesh repair” is far from standardized.

A wide array of prosthetic meshes is available for incisional hernia repair. Most of these meshes

are comparable in terms of adhesion formation and incorporation into the abdominal wall

and do not differ in clinically significant outcomes such as post-operative complication rates or

recurrences (9,10).

Uniform indications for laparoscopic or open incisional hernia repair have not been determined.

Several randomized controlled trials, reviews and meta-analysis have shown that laparoscopic

incisional hernia repair is safe and is associated with a shorter hospital stay and fewer wound

infections (11-14). Recurrences rates, chronic pain and quality of life after open and laparoscopic

incisional hernia repair are similar (1,12,15). Patients with large abdominal wall defects appear

to benefit from reconstruction of the midline, which is usually done in open repair, in order to

restore the functionality of the abdominal wall (16). The fear for intra-abdominal adhesions due

to former (complicated) surgeries might direct the surgeon to choose an open repair. It remains

unclear whether the cost-effectiveness of the laparoscopic repair is superior to open surgery (12-

14).



1Proper evaluation of outcomes of incisional hernia repair requires clear definition of size and

location of these hernias. The European Hernia Society (EHS) categorized incisional hernias

to facilitate scientific incisional hernia research (17). A classification system of abdominal wall

hernias has been formulated. The classification of incisional hernias might help in and defining

the optimal treatment approach per subgroup.

Traditional open repair involves repair of the hernia employing the scar of the previous surgery. A

preperitoneal, sublay or onlay mesh repair (picture 1), sometimes combined with an augmentation

of the abdominal wall through component separation technique can be performed. The mesh is

held in position between the muscular layers of the abdominal wall, usually in combination with

sutures.

The morbidity of open incisional hernia repair varying from respiratory infections, severe chronic

pain, recurrences to wound and mesh infections occur in 15 percent of patients. The position of

the mesh whether onlay, inlay or sublay does not affect the morbidity rate (2).

Component separation technique is a procedure based on enlargement of the abdominal wall by

separating the muscular layers in order to close the abdomen tension-free. The amount of soft

tissue dissection that needs to be done in the abdominal wall is considerable, leading to wound

related complications in up to 50% of the cases (18). The component separation technique

without the use of a mesh should only be used when contents of the gut are present in the

abdominal cavity due to perforation of the gut, because bacteria will lodge on the mesh resulting

in chronic infection.

Picture 1.

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14 | Chapter 1

With the growing interest of general surgeons in laparoscopy, which started in the late 1980s,

surgeons started to perform laparoscopic incisional hernia repairs (19). The laparoscopic repair

entails employment of mesh that is placed intraperitoneally covering the fascial defect while

leaving the hernia sac in place. The mesh is fixed to the abdominal wall with transfascial sutures

and/or with the use of tackers (picture 2). In general, the fascial edges are not brought together

in the laparoscopic repair although some early experiences of laparoscopic closure of the midline

have been reported.

Picture 2.

Repair of incisional hernias is associated with considerable morbidity for the patient as well

with costs due to the surgical procedure and loss of economic productivity. A reduction of the

complication rate of incisional hernia surgery may lead to earlier recovery, which in turn shortens

hospital stay and promotes a faster return to work. Optimizing and standardizing the surgical

treatment of patients with an incisional hernia potentially saves our patients morbidity, and could

save our society millions of euros.

Central questions and outline of this thesis

The main question of this thesis is:

Is it possible to determine the optimal management of incisional abdominal and groin hernias

through clinical evaluation, literature research and assessment by experts throughout Europe?



1In the first two chapters, the open onlay mesh technique for the repair of large incisional

hernias was evaluated. Other open techniques, such as the component separations technique,

are accepted for the repair of large incisional hernias. These techniques are invasive and some

require entering the abdominal cavity. The modified onlay technique was used to repair the more

complicated abdominal wall defects, i.e. after open-abdomen treatment or fascial necrosis. A

retrospective analysis of these patients was performed to analyze whether this is an appropriate

technique for the repair of large incisional hernias (chapter 2). The next step was to examine the

quality of life of these patients after surgery (chapter 3).

Patients with an open abdomen develop a specific form of incisional hernia when there is no

delayed fascial closure. A standard approach to the management of an open abdomen is absent.

Patients who were treated with an open abdomen at a university hospital and a large teaching

hospital were selected and evaluated (chapter 4). A review of the literature was performed

to record the outcomes of various methods of fascial closure and correlate these with the

development of an incisional hernia.

A large clinical trial randomizing patients with incisional hernias either for open or laparoscopic

repair, called the “INCH trial” was started. The aim of this trial is to examine if laparoscopic

incisional hernia repair is superior to open incisional hernia repair in terms of hospital stay and

return to normal activities. Patients with an incisional hernia suitable for laparoscopic repair are

randomized to either laparoscopic or open repair. Alongside the trial, all the patients with an

incisional hernia who do not want to participate, whose hernia is considered to be unsuitable

for laparoscopic repair and the patients who are treated conservatively will be registered in a

prospective database. The preparations of the INCH trial started in 2010 and a study protocol

was written (chapter 7). Funding was gained through national and European societies. Ethical

approval was obtained and the trial started in July 2012 and is still running.

Two studies were initiated in preparation of the start of the INCH trial. A review was performed

to determine the influence of surgical technique (overlap, use of transfascial sutures and type of

mesh) on the recurrence rate in laparoscopic incisional hernia repair (chapter 6).

The Carolina Comfort Scale, a disease specific questionnaire to measure quality of life that has

been validated in English, was validated in Dutch in order to use this questionnaire in the INCH

trial (chapter 5).

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16 | Chapter 1

While initiating the INCH trial, the Consensus Development Conference on endoscopic groin

hernia repair was organized for the European Association of Endoscopic Surgeons (chapter 9).

The aim was to provide practical guidelines employing available medical evidence combined with

the opinions of an expert panel and the membership of the EAES.



1References

1. Cassar K, Munro A. Surgical treatment of incisional hernia. Br J Surg 2002, May;89(5):534-45.

2. den Hartog D, Dur AH, Tuinebreijer WE, Kreis RW. Open surgical procedures for incisional hernias. Cochrane Database Syst Rev 2008(3):CD006438.

3. Llaguna OH, Avgerinos DV, Lugo JZ, Matatov T, Abbadessa B, Martz JE, Leitman IM. Incidence and risk factors for the development of incisional hernia following elective laparoscopic versus open colon resections. Am J Surg 2010, Aug;200(2):265-9.

4. Rosch R, Junge K, Knops M, Lynen P, Klinge U, Schumpelick V. Analysis of collagen-interacting proteins in patients with incisional hernias. Langenbecks Arch Surg 2003, Feb;387(11-12):427-32.

5. Nieuwenhuizen J, Kleinrensink GJ, Hop WC, Jeekel J, Lange JF. Indications for incisional hernia repair: An international questionnaire among hernia surgeons. Hernia 2008, Jun;12(3):223-5.

6. Courtney CA, Lee AC, Wilson C, O’Dwyer PJ. Ventral hernia repair: A study of current practice. Hernia 2003, Mar;7(1):44-6.

7. Vardanian AJ, Farmer DG, Ghobrial RM, Busuttil RW, Hiatt JR. Incisional hernia after liver transplantation. J Am Coll Surg 2006, Oct;203(4):421-5.

8. Luijendijk RW, Hop WC, van den Tol MP, de Lange DC, Braaksma MM, IJzermans JN, et al. A comparison of suture repair with mesh repair for incisional hernia. N Engl J Med 2000, Aug 10;343(6):392-8.

9. Eriksen JR, Gögenur I, Rosenberg J. Choice of mesh for laparoscopic ventral hernia repair. Hernia 2007, Dec;11(6):481-92.

10. Colon MJ, Telem DA, Chin E, Weber K, Divino CM, Nguyen SQ. Polyester composite versus PTFE in laparoscopic ventral hernia repair. JSLS 2011;15(3):305-8.

11. Olmi S, Scaini A, Cesana GC, Erba L, Croce E. Laparoscopic versus open incisional hernia repair: An open randomized controlled study. Surg Endosc 2007, Apr;21(4):555-9.

12. Sauerland S, Walgenbach M, Habermalz B, Seiler CM, Miserez M. Laparoscopic versus open surgical techniques for ventral or incisional hernia repair. Cochrane Database Syst Rev 2011(3):CD007781.

13. Forbes SS, Eskicioglu C, McLeod RS, Okrainec A. Meta-analysis of randomized controlled trials comparing open and laparoscopic ventral and incisional hernia repair with mesh. Br J Surg 2009, Aug;96(8):851-8.

14. Sajid MS, Bokhari SA, Mallick AS, Cheek E, Baig MK. Laparoscopic versus open repair of incisional/ventral hernia: A meta-analysis. Am J Surg 2009, Jan;197(1):64-72.

15. Itani KM, Hur K, Kim LT, Anthony T, Berger DH, Reda D, et al. Comparison of laparoscopic and open repair with mesh for the treatment of ventral incisional hernia: A randomized trial. Arch Surg 2010, Apr;145(4):322-8; discussion 328.

16. Eker HH, Hansson BM, Buunen M, Janssen IM, Pierik RE, Hop WC, et al. Laparoscopic vs. Open incisional hernia repair: A randomized clinical trial. JAMA Surg 2013, Mar;148(3):259-63.

17. Muysoms FE, Miserez M, Berrevoet F, Campanelli G, Champault GG, Chelala E, et al. Classification of primary and incisional abdominal wall hernias. Hernia 2009, Aug;13(4):407-14.

18. de Vries Reilingh TS, van Goor H, Rosman C, Bemelmans MH, de Jong D, van Nieuwenhoven EJ, et al. “Components separation technique” for the repair of large abdominal wall hernias. J Am Coll Surg 2003, Jan;196(1):32-7.

19. LeBlanc KA, Booth WV. Laparoscopic repair of incisional abdominal hernias using expanded polytetrafluoroethylene: Preliminary findings. Surg Laparosc Endosc 1993, Feb;3(1):39-41.

PART I

Incisional hernias

Chapter 2

Modified onlay technique for the repair

of the more complicated incisional hernias:

Single centre evaluation of a large cohort

Poelman MM

Langenhorst BL

Schellekens JF

Schreurs WH

Hernia. 2010 Aug;14(4):369-74.

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22 | Chapter 2

Abstract

Background The repair of incisional hernias remains a challenge for the general surgeon.

Indications for surgery are severe bowel obstruction, as well as aesthetic problems. There are

various surgical methods to correct these hernias with varying results. However, the gold standard

has not yet been found. Both laparoscopic repair and the component separation technique (CTS)

have proven to be acceptable techniques; however, they are not always suitable to resolve the

more complicated abdominal wall defects, i.e. after open abdomen treatment or fascial necrosis.

In our hospital we developed a new onlay technique, which we have evaluated in the following

research.

Patients & Methods During a period of 10 years (1996-2007) 101 patients with an incisional

hernia were corrected with the new onlay technique. A marlex mesh of dimensions at least 10x20

cm was used, overlapping the fascia by at least 5cm at each side. This mesh was stapled onto the

fascia with skin staples. Of the 101 patient there were 45 men and 56 women, with a mean age

of 55 years. Nine patients died and 13 were lost during follow up. Of the remaining 79 patients,

eight refused to participate. The mean follow-up time was 64 months (normal distribution, SD

34 months).

This cohort of 101 patients was studied retrospectively.

Results Seventy-one of the 101 patients were evaluated at our outpatient clinic. For 24 patients

(25%) the operation was for a recurrence after an inscisional hernia correction in the past.

Twenty-one patients (20%) had an open abdomen treatment in their medical history. The surgical

procedure was technically possible in all patients and the mean operation time was 63 minutes.

The median admission time was 4,5 days (Quartiles 3-6,25). The mean follow-up time was 64

months (SD 35 months). A seroma was reported in 27 of 101 patients (27%) and a wound

infection in 22 patients (21%) of which 7 patients had to be re-operated. Only if a patient was

evaluated at our outpatient clinic could reherniation have been scored; this occurred in 11 of 71

patients (16%).

Conclusion This technique is an effective and simple procedure to correct incisional hernias with

acceptable complication rates and is feasible even in the more complicated hernias.

Key Words Incisional hernia, abdominal wall defects, mesh repair, hernia


Modified onlay technique for the repair of the more complicated incisional hernias | 23

2

Introduction

Incisional hernias are a frequent complication after abdominal surgery, with an incidence of 10-

23%(1;2). Although these hernias can be treated conservatively (with techniques like a bodice),

frequently, there are reasons to correct them surgically. Incisional hernias enlarge over time, cause

pain and/or aesthetic complaints. They can cause serious complications like bowel obstruction

due to incarceration or strangulation. Patients suffer from these hernias and their quality of life

as well as their chances for employment are reduced (3). Improvement of the quality of life is the

major reason to seek surgical care (4-6).

Incisional hernia surgery still is a challenge for the general surgeon. Repair of these hernias comes

with a high recurrence rate, high morbidity and, therefore high costs. Frequent complications are

reherniation, seroma formation and wound infection (7;8). Many techniques have been studied

but the gold standard has not yet been found (2;3;9). This is probably, at least partially, due to

the multifactorial aetiology of incisional hernias. Failures of the surgical technique, deterioration

of the patient’s nutritional status as well as interpersonal factors contribute. Reherniation rates

of 0-36% have been reported, even after mesh repair (3;7;8;10). There is no evidence that

laparoscopic repair has a lower recurrence rate compared to open repair (11;12) and a recent

Cochrane analysis states that there is insufficient evidence as to which mesh position or which

type of mesh should be used (3).

Most challenging are, of course, the large and/or the complicated hernias. There is no superior

technique and the overall results in all series are, at best, moderate. In this article, we report a

new technique, an onlay polypropylene mesh fixed with multiple skin staples. A single-centre

retrospective study was performed.

Methods

Patients

All patients who had an incisional hernia operation between January 1996 and January 2007

were selected. Out of this group the patients who were operated using an onlay polypropylene

mesh, with a minimum size of 10x20 cm fixed with skin staples were included in this study. This

onlay-technique was only used when a large, complicated hernia was present. Smaller, simple

hernias were corrected using laparoscopy or open techniques.

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24 | Chapter 2

Surgical procedure

All operations are performed under general anaesthesia. Patients are placed in the supine

position with their arms tucked in at the sides. After disinfection, one dosis of antibiotics was

given prior to the start of the operation (cefuroxim 1,500 mg iv). The skin scar was sometimes

excised and the subcutis opened. A de-epithelialisation was performed when the fascia was

absent and the subcutis was spread until the borders of the remaining fascia were found. A plane

of at least 5 cm was made in all directions over the fascia. The fascial edges were approximated

as far as possible and closed using an absorbable vicryl suture, putting the de-epithelialized

part intra-abdominally without entering the abdominal cavity. After the hernia was successfully

approximated and haemostasis was achieved the Marlex mesh (Marlex©; C.R. Bard) was placed

on the freed fascial edges and trimmed to fit. The mesh was never put directly on the intestines.

Fascia, de-epithelialized tissue or omentum was always used to put in between the intestines and

the mesh. The mesh was fixed with over 150 skin staples to the fascia (figure 1). Two suction

drains were placed on top of the mesh and the subcutis and skin were closed in layers.

Follow-up

All patients still alive were sent a letter to ask if they were willing to visit our outpatient clinic

for an evaluation. Patients who opted not to participate were asked for what reason. This was

then documented. After written consent was given, patients were invited to our outpatient clinic

for an interview and physical examination of their abdomen. A recurrent hernia was diagnosed

when a facial defect could be palpated when lifting the head from the examination table to raise

the abdominal pressure. If this examination was not conclusive (in two patients) a computed

tomography (CT) scan was performed.

Demographics as well as pre-, peri- and postoperative data were collected. Patient history and

special features such as history of an open abdomen were noted. Post-operative outcomes were

wound-edge necrosis, wound infection, fistulas, seromas, bleedings, re-admission and length of

stay, re-operation, mortality and re-herniation in the follow-up.

All of the data were entered into an SPSS database. All statistics mentioned are means or medians

along with their extremes or are in frequencies.



2

Figure 1.

Results

Patients

Between January 1996 and January 2007, 119 patients with incisional hernias were treated using

this onlay technique. The same two surgeons operated all of these patients, except six. These six

patients were excluded from this study because it was not certain that exactly the same technique

was used. In 12 patients, an attempt was made to correct the incisional hernia with the new

onlay technique, but failed due to iatrogenic bowel lesions. Eventually these hernias were not

corrected with a mesh. This group was also excluded. In total, 101 patients were included.

Mean age at time of operation was 55 years (normal distribution, SD 14,4 years). There were

45 (44%) males and 56 (56%) females. Nine of these patients had died at time of evaluation.

These deaths were not related to the hernia correction. Thirteen patients were lost to follow

up. Eight patients refused to participate, three of them because they were dissatisfied and five

because of logistic reasons. Therefore, it was possible to evaluate only 71 of the 101 patients in

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26 | Chapter 2

our outpatient clinic. Seroma formation, infection and co morbidity is reported using the files of

all 101 patients. Recurrence was scored after the patients were seen in follow-up and is therefore

only mentioned in the outpatient group (n=71).

Indications for surgery were complaints of bowel obstruction, i.e. patients felt pain or had difficulties

passing stool. Only a minority of the patients found the hernia aesthetically unacceptable.

The most prevalent comorbidity (table 1) is obesity (mean Body Mass Index [BMI] >29); 43 patients

had a BMI of more than 29. Nineteen patients had a history of cardiovascular disease. There were

11 diabetes, 27 patient smoked and 5 used corticosteroids. Seventy patients (70%) developed an

incisional hernia after a medial laparotomy. About 18 patients had a recurrent hernia after former

incisional hernia repair using another technique. There were 21 patients (20%) with a history of

open abdomen treatment.

Table 1: Baseline characteristics of patients

Baseline characteristics N (%) mean SD minimum maximumGender 56 (55) femaleDiabetes 11 (11)Cardiovascular disease 19 (19)Pulmonary disease 18 (18)Smokers 27 (27)Use of corticosteroids 5 (5)History of open abdomen treatment 21 (20)ASA-score* at time of operation 1,8 0,6 1 3BMI 29 9 19 48

The surgical procedure was technically possible in all patients and the mean operation time was

63 minutes. The median admission time was 4,5 days (Quartiles 3-6,25). The mean follow-up

was 64 months (SD 34 months). During follow-up, 27 patients (27%) were seen more frequently

in the outpatient department because of a seroma. A wound infection was found in 22 patients

(21%). Seven of these patients had to be operated again: three with a seroma and a wound-

infection, two with only a seroma and two with only a wound infection. In the majority of cases,

the patient with seromas and infections could be treated without surgical interference.

About six patients (6%) suffered chronic pain and, in one case, the mesh had to be removed.

Whether or not this resolved the pain is unknown because the patient was lost for follow up.

Most patients report pain or an unpleasant sensation when bending over, due to stiffness of



2

the mesh. None of them considered this invalidating. Migration of the mesh was not seen. Re-

herniation occurred in 11 patients (16%) (Table 2).

Table 2: Complications

N (%) Surgical interferenceSeroma 27 (27) 5Infection 22 (21) 5Wound edge necrosis 17 (17) 0Recurrence 11 (16)Chronic pain 6 (6) 1Re-admission 15 (15)Mortality 0Re-operation 16 (6) 16Post-surgical complications* 23 (23)

* non-procedure related complications

Discussion

Large abdominal wall defects are a challenge for surgeons. The incidence of incisional hernias

is high and the surgical techniques to correct them challenging. Conditions associated with the

development of incisional hernias are suture technique, wound infection, increased abdominal

wall tension, metabolic connective tissue disorder and abdominal aortic aneurysms (1;2;7;13).

In the last decade a lot of research has been done to find the best method to resolve incisional

hernias. Even in a large surgical department as ours, only 10 to 12 onlay procedures are performed

annually, which makes it difficult to evaluate techniques by randomised controlled trials. What

has been proven is that the use of a mesh to correct these hernias is necessary in order to avoid

high recurrence rates (2;3;7-10).

The Component Separation Technique (CST) was first described by Ramirez (14) in 1990 to

reconstruct the abdominal wall without the use of prosthetic material. It was first tested on

cadavers and is based on enlarging the abdominal wall surface through translation of muscular

layers.

Several in vivo studies were performed after the introduction of the CST. In 2007, De Vries Reilingh

wrote his thesis about the correction of large abdominal wall defects and studied a modified CST

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28 | Chapter 2

to close these defects. He added a laparoscopic element, thereby, diminishing the wound surface.

He states that autologous tissue repair like the CST should be reserved for patients in whom

prosthetic repair is contraindicated, i.e. in contaminated operations, as the rate of reherniation is

similar to that found after open suture repair (15). He found wound complication rates of 33%

and a recurrence rate of 32% using the CST (16).

In 2007, Van Geffen also wrote a thesis about the CST for treatment of patients with large

abdominal wall defects. He modulated the CST technique and combined it with an augmenting

mesh. He compared groups with and without the use of a mesh and found less recurrences in the

mesh group; however, the group size was too small to be significant. The overall study treated

95 patients and they found a recurrence of 15,6% after a median follow-up of 48 months (17).

Several studies (16-19) report a recurrence rate varying from 5-32% after the use of CST, but

most studies lack study size or duration of follow-up.

A recent Cochrane analysis performed by den Hartog et al. states that there is insufficient evidence

as to which type of mesh or in which position it should be used in open ventral hernia repair. Also,

insufficient evidence was found to advocate the use of CST (3).

Nevertheless, recent studies performed in Germany and the United States report good results

using laparoscopic repair and a modified CST with recurrence rates as low as 5% (11;19;20).

Conditions associated with recurrent herniation are obesity, previous abdominal aneurysm

surgery, suture repair, chronic constipation, chronic obstructive airway disease, smoking and

occupational lifting (21).

The wide overlap of the previously described onlay technique allows a large surface area for in

growth of connective tissue, leading to permanent fixation within the abdominal wall. We believe

that, with incisional hernias, the whole scar is insufficient and, therefore, needs to be corrected

as a whole. The wide placement decreases the risk of recurrence and allows for the shrinkage of

the mesh; however this might also lead to the formation of seromas.

Complications like wound-healing disorders, seroma, haematoma and mesh removal are more

common after an onlay procedure compared to other techniques (7;9). Seroma formation was

reported in different studies (1;7;22) to range from 0 to 63% after open mesh repair. In our

study, 28% patients suffered seroma formation; most of them could be treated conservatively

in the outpatient clinic. The high incidence of seroma formation may be caused by the extensive

dissection to separate the skin and subcutaneous tissue from the fascia and the subcutaneous



2

implantation of the large mesh. It is known that a large wound surface predisposes for seroma

formation(16).

Fistula formation is reported in 3% of cases in the literature (2). In our study, it did not occur.

This is probably due to the fact that the mesh was never placed directly on the intestines. Even

when the hernia could not be closed great caution was taken to prevent this. Omentum was then

placed underneath the mesh. When the intestines were, however, injured during the operation or

could not be covered, a mesh wasn’t used. Prosthesis removal ranges from 0-2.5% in literature;

in our study in only one patient the mesh had to be removed- this was due to pain.

In this study, 101 patients were included with large incisional hernias. This large cohort study

evaluates the correction of large incisional abdominal wall hernias, which were corrected with

this particular technique. Twelve patients were excluded because of bowel injury; this, however,

is not related to the correction technique but shows the challenge of performing an incisional

hernia correction in this group. A recurrence rate of 16% was found, which is comparable to

other techniques. Therefore, this technique, although it has its disadvantaged, is very useful in the

repairing incisional hernias in patients who need an uncomplicated and fast surgical procedure.

The advantages of the technique are the mean operation time of 63 minutes, no mortality and no

unacceptable technical difficulties to put in the mesh. Therefore, it seems to be an effective and

simple way to repair extremely large, as well as the more complicated, hernias.

Of course, the final indication for an abdominal wall correction needs to be tailored to the kind

of hernia the patient has; small or large, simple or complicated.

At this moment in time, there is no gold standard available, and we even state that, for incisional

hernias, there cannot be a gold standard because different types of incisional hernias and

different patient groups need a different treatment approach. Perhaps a superior classification of

the hernias can help to decide which therapy is best for which patient.

Dietz et al. described a classification system in order to subdivide different kinds of incisional

hernias (23;24). They enlist morphology, patient body type and risk factors in the assessment

of prognosis. After classifying different kinds of hernias and studying these groups separately, it

might be easier to make surgical recommendations for these different groups.

Quality of life (QOL) is a major endpoint in evaluating surgical techniques; however, no study

concerning incisional hernia repair has included this. Therefore, we decided to score the QOL

of the patients corrected with this technique for further investigation. We will also perform a

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30 | Chapter 2

subgroup analysis of the patients whose abdominal wall was corrected after open abdomen

treatment. Subsequently we hope to be able to make further recommendations for which

patients should be operated using this technique.



2

References

1. Kingsnorth A, LeBlanc K. (2003) Hernias: inguinal and incisional. Lancet: 362(9395):1561-71.

2. Cassar K, Munro A. (2002) Surgical treatment of incisional hernia. Br J Surg: 89(5):534-45.

3. den Hartog D, Dur AH, Tuinebreijer WE, Kreis RW. (2008) Open surgical procedures for incisional hernias. Cochrane.Database.Syst.Rev 2008(3):CD006438.

4. Urbach DR.(2005) Measuring quality of life after surgery. Surg Innov.: 12(2):161-5.

5. Wright JG. (1999) Outcomes research: what to measure. World J Surg: 23(12):1224-6.

6. Heniford BT, Walters AL, Lincourt AE, Novitsky YW, Hope WW, Kercher KW. (2008) Comparison of generic versus specific quality-of-life scales for mesh hernia repairs. J Am Coll.Surg: 206(4):638-44.

7. Luijendijk RW, Hop WC, van den Tol MP, de Lange DC, Braaksma MM, IJzermans JN et al. (2000) A comparison of suture repair with mesh repair for incisional hernia. N Engl J Med: 343(6):392-8.

8. Burger JW, Luijendijk RW, Hop WC, Halm JA, Verdaasdonk EG, Jeekel J. (2004) Long-term follow-up of a randomized controlled trial of suture versus mesh repair of incisional hernia. Ann Surg: 240(4):578-83.

9. Korenkov M, Paul A, Sauerland S, Neugebauer E, Arndt M, Chevrel JP et al. (2001) Classification and surgical treatment of incisional hernia. Results of an experts’ meeting. Langenbecks Arch Surg: 386(1):65-73.

10. Korenkov M, Sauerland S, Arndt M, Bograd L, Neugebauer EA, Troidl H. (2002) Randomized clinical trial of suture repair, polypropylene mesh or autodermal hernioplasty for incisional hernia. Br J Surg: 89(1):50-6.

11. Gananadha S, Samra JS, Smith GS, Smith RC, Leibman S, Hugh TJ. (2008) Laparoscopic ePTFE mesh repair of incisional and ventral hernias. ANZ J Surg: 78(10):907-13.

12. Barbaros U, Asoglu O, Seven R, Erbil Y, Dinccag A, Deveci U et al. (2007) The comparison of laparoscopic and open ventral hernia repairs: a prospective randomized study. Hernia: 11(1):51-6.

13. Liapis CD, Dimitroulis DA, Kakisis JD, Nikolaou AN, Skandalakis P, Daskalopoulos M et al. (2004) Incidence of incisional hernias in patients operated on for aneurysm or occlusive disease. Am Surg: 70(6):550-2.

14. Ramirez OM, Ruas E, Dellon AL. (1990) “Components separation” method for closure of abdominal-wall defects: an anatomic and clinical study. Plast.Reconstr.Surg: 86(3):519-26.

15. Vries Reilingh TS, Bodegom ME, van Goor H, Hartman EH, van der Wilt GJ, Bleichrodt RP. (2007) Autologous tissue repair of large abdominal wall defects. Br J Surg: 94(7):791-803.

16. Vries Reilingh TS, van Goor H, Rosman C, Bemelmans MH, de Jong D, van Nieuwenhoven EJ et al. (2003) “Components separation technique” for the repair of large abdominal wall hernias. J Am Coll.Surg: 196(1):32-7.

17. H.J.A.A.van Geffen, D.Kreb, R.K.J.Simmermacher, J.Olsman, Chr.van der Werken. (2009) Long term results of reconstructing large abdominal wall defects with the Companent Separation Method. In: Prof.Dr.V.Schumpelick, Prof.Dr.Robert J.Fitzgibbons, editors. Recurrent Hernia: 205-11.

18. Lowe JB, Garza JR, Bowman JL, Rohrich RJ, Strodel WE. (2000) Endoscopically assisted “components separation” for closure of abdominal wall defects. Plast.Reconstr.Surg: 105(2):720-9.

19. Moore M, Bax T, MacFarlane M, McNevin MS. (2008) Outcomes of the fascial component separation technique with synthetic mesh reinforcement for repair of complex ventral incisional hernias in the morbidly obese. Am J Surg: 195(5):575-9.

20. Benhidjeb T, Benecke C, Strik MW. (2008) Incisional hernia repair: sublay or intraperitoneal onlay mesh. Zentralbl.Chir: 133(5):458-63.

21. Vidovic D, Jurisic D, Franjic BD, Glavan E, Ledinsky M, Bekavac-Beslin M. (2006) Factors affecting recurrence after incisional hernia repair. Hernia: 10(4):322-5.

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32 | Chapter 2

22. Vries Reilingh TS, van Geldere D, Langenhorst B, de Jong D, van der Wilt GJ, van Goor H et al. (2004) Repair of large midline incisional hernias with polypropylene mesh: comparison of three operative techniques. Hernia: 8(1):56-9.

23. Dietz UA, Hamelmann W, Winkler MS, Debus ES, Malafaia O, Czeczko NG et al. (2007) An alternative classification of incisional hernias enlisting morphology, body type and risk factors in the assessment of prognosis and tailoring of surgical technique. J Plast.Reconstr.Aesthet.Surg: 60(4):383-8.

24. Winkler MS, Gerharz E, Dietz UA. (2008) Overview and evolving strategies of ventral hernia repair.]. Urologe A: 47(6):740-7.

Chapter 3

Health-related quality of life in patients treated

for incisional hernia with an onlay technique

M.M. Poelman

J.F. Schellekens

B.L.A.M. Langenhorst

W.H. Schreurs

Hernia. 2010 Jun;14(3):237-42.

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34 | Chapter 3

Abstract

Background An incisional hernia is a frequent complication of abdominal surgery. Repair of

incisional hernias comes with a high risk of reherniation and serious complications. With the

introduction of mesh repair, recurrence rates have decreased and subsequent clinical outcomes

have improved. Whereas further research needs to be done to improve complication rates and

recurrence, the focus has now been placed on quality-of-life outcomes in patients undergoing

these repairs. The aim of this study was to investigate the long-term health-related quality-of-life

(HRQL) of patients who were treated for incisional hernias using an onlay technique.

Patients & Methods Over a period of 10 years (1997-2007) 101 patients with an incisional hernia

were treated with an onlay marlex mesh, fixed on the fascia with skin staples. Of the 101 patients

there were 45 males and 56 females, their mean age was 55 years. Nine patients died and 13

were lost during follow up. Of the remaining 79 patients, 8 refused to participate. The mean

follow-up time was 64 months (normal distribution, SD 34 months). The Short Form 36 (SF-

36©) and the Karnofsky Performance Scale (KPS) and a semi-structured interview were used to

measure HRQL.

Results Seventy-one of the 101 patients were evaluated at our outpatient clinic. Twenty-one

patients (20%) had an open abdomen treatment in their medical history. The median admission

time was 4,5 days (Quartiles 3-6,25). Mean follow-up time was 64 months (SD 35 months). A

seroma was reported in 27 of the 101 patients (27%) and a wound infection in 22 patients (21%)

of which 5 patients had to be re-operated. Only if a patient was evaluated at our out-patient clinic

could reherniation be scored; this occurred in 11 of 71 patients (16%).

The evaluation of HRQOL showed equal SF-36© scores for patients treated for an incisional hernia

compared to their matched controls. Patients with a history of an open abdominal treatment did

not score significantly lower compared to patients without such a treatment. The median KPS

score was 75, indicating that activities could be performed with effort and patients had some

signs of disease.

Conclusion HRQL is the same in patients treated for an incisional hernia compared to the matched

controls. Therefore, the onlay technique seems to be an acceptable method to repair large

incisional hernias.


Health-related quality of life in patients treated for incisional hernia with an onlay technique | 35

3

Introduction

Incisional hernias are a frequent complication of abdominal surgery, with an incidence of 10-23%

(1, 2). Although they can be treated conservatively, patients frequently choose to have them

corrected surgically. Incisional hernias enlarge over time and might give aesthetic complaints.

They can cause serious complications like strangulation or incarceration of the bowel. The quality

of life of these patients, as well as their chances for re-employment, is reduced (3). Of all patients

with an incisional hernia, 20% is treated conservatively (4). The major reason to seek surgical care

is to improve the quality of life (5-7).

Repair of these hernias comes with a high recurrence rate, high morbidity and, therefore high

costs. Complications like seroma formation and wound infections are usual (8). These problems,

in combination with the technical difficulties, might discourage many surgeons to perform an

abdominal wall reconstruction. Still, these hernias, especially the larger ones, can give invalidating

complaints such as bulging of the abdominal wall, chronic wounds and immobility necessitating

surgical treatment (9). The treatment of large incisional hernias is a challenge for surgeons and a

risk for the patient undergoing the surgery.

Many aspects of incisional hernia surgery are to be answered, as there is no gold standard for

this procedure (1,3,10). This is probably, at least partially, due to the multifactorial aetiology

of abdominal wall defects. Different methods of hernioplasty and several prosthetic materials

are currently used. Recurrence rates up to 36% have been reported even after mesh repair

(3,8,11,12). A recent Cochrane review states that there is insufficient evidence as to which mesh

position or which type of mesh should be used (3).

A variety of measures can be used to determine the outcome of surgical treatment. They can be

categorized as utilization measures, clinical measures, traditional measures of convalescence and

functional status/health-related quality-of-life (HRQL) measures (5). Improvement of the quality

of life is a way for patients to judge the effect of their treatment (5-7). With improving clinical

outcomes, HRQL has become a major endpoint in the treatment of patients (5, 13). HRQL has

been assessed in patients with an open abdominal treatment, severe peritonitis and patients

undergoing inguinal hernia repair (14-16). Data on HRQL in patients treated for incisional hernia

are not widely available. The assessment of HRQL yields essential information of the somatic

success of treatment and helps to determine the overall effect of surgery on patients with

incisional hernias. The outcome might help to determine when to correct an incisional hernia and

with which technique.

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36 | Chapter 3

The aim of this study was to investigate the long-term HRQL in patients treated for incisional

hernias with an onlay procedure. We performed a matched-control retrospective study.

Methods

Patients

All patients who had an incisional hernia operation between January 1996 and January 2007

were selected and put onto a database. Out of this group, the patients who were operated using

an onlay polypropylene mesh, with a minimum size of 10x20 cm fixed with skin staples, were

included. This onlay-technique was only used when a large, complicated hernia was present;

smaller, simple hernias were corrected using laparoscopy or open techniques.

Follow-up

All patients still alive were sent a letter to ask if they were willing to visit our outpatient clinic for

an evaluation. Patients who opted not to participate were asked for what reason. After written

consent was given, patients were invited to our outpatient clinic for an interview and physical

examination of their abdomen. A recurrent hernia was diagnosed when a facial defect could be

palpated when lifting the head from the examination table to raise the abdominal pressure. If this

examination was not conclusive, which was the case in two patients, a CT-scan was performed.

Demographics, pre-, peri- and postoperative data were collected. Post-operative outcomes were

wound-edge necrosis, wound infection, fistulas, seromas, hematoma, re-admission and length of

stay, re-operation, mortality and reherniation in the follow-up.

HRQL questionnaires

HRQL was assessed using the Study Short Form 36 (SF-36©) and the Karnofsky Performance

Status (KPS). The SF-36© is one of the most widely used generic measures in HRQL and is currently

the gold standard for measuring quality of life in patients who have undergone incisional hernia

repair in the US (7, 17). The SF-36© has been validated for many diseases and has been translated

into several languages, including Dutch (18). The SF-36© consists of 36 multiple-choice items that

are used to calculate eight subscales: physical functioning (PF), role physical (RP), bodily pain (BP),

general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health

(MH). The eight subscales can be converted via a syntax into values ranging from 0 (poor health)

to 100 (best health), resulting in two major subscales: physical health and mental health. Three

of the eight SF-36© subscales (physical functioning, bodily pain and role physical) were considered

as main outcomes.



3

The KPS was first described in 1949 and measures functional performance on a decimal scale

from 0 to 100, where 100 is perfect health and 0 is death. Patients have to indicate which

statement applies best to their condition, where 100 indicates that the patient can fully function

and perform all activities of daily life independently, with no evidence of disease.

Patients were asked to score their health after the hernia correction and satisfaction of the

treatment on a ten-point scale, were 10 was the best and 1 the worst condition possible, to

measure the self-perceived health.

Statistical analysis

All data was put in an SPSS database. The Pearson χ² test was used to compare the study

population to the non-responders regarding patient characteristics.

A national database from the Netherlands Cancer Institute and the Netherlands Organization for

Applied Scientific Research provided values of the Medical Outcome Study Short Form 36 (SF-36©)

for a matched population without an incisional hernia. Patients were matched with controls from

the database with respect to age, sex and the presence of cancer.

These values were compared to the results of the patients treated for incisional hernias. A

matched-pair analysis was performed using the Wilcoxon signed rank test. Spearman correlation

coefficients were calculated between HRQL of life scores and history of open abdomen. Two-

tailed p<0.05 was considered significant. All statistical analysis was performed using SPSS©

software (version 14.0; SPP, Chicago, Illinois, USA).

Results

Patients

Between January 1996 and January 2007, 107 patients with an incisional hernia were treated

using this specific onlay technique. The same two surgeons operated all patients selected, except

six. These 6 patients were excluded from this study because it was not certain that exactly the

same technique was used. Therefore, 101 patients were included in this study.

Mean age at time of operation was 55 years (normal distribution, SD 14,4 years). There were 45

(44%) males and 56 (56%) females. Nine of these patients had died at time of evaluation. These

deaths were not related to the hernia correction. Thirteen patients were lost to follow up. Eight

patients refused to participate, three of them because they were dissatisfied and five because

of logistic reasons. Therefore, it was possible to evaluate only 71 of the 101 patients in our

outpatient clinic. There were 30 males and 41 females.

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38 | Chapter 3

Seroma formation, infection and co morbidity was reported using the medical records of all 101

patients. Recurrence could only be scored if a patient was seen at the out-patient clinic and is,

therefore, only mentioned in the out-patient controlled group (n=71).

The indications for surgery were complaints of bowel obstruction, i.e. patients felt pain or

had difficulties passing stool; only a minority of the patients found the hernia aesthetically

unacceptable.

The most prevalent co-morbidity (table 1) is obesity (mean BMI >29); 43 patients had a BMI

of more than 29. Nineteen patients had cardiovascular disease. There were 11 diabetics, 27

smokers and 5 patients used corticosteroids. Seventy patients (70%) developed an incisional

hernia after a medial laparotomy. Eighteen patients had a recurrent hernia after former incisional

hernia repair using another technique. There were 21 patients (20%) with a history of open

abdomen treatment.

Table 1: Baseline characteristics of patients

% mean SD minimum maximumgender 55% femalemalignancy at time of operation 15%diabetes 7%cardiac disease 16%pulmonary disease 18%smoker 25%use of corticosteroids 3%history of open abdomen treatment 20%ASA-score* at time of operation 1,8 0,6 1 3BMI 29 6 19 48

*American society of Anesthesiologists

The primary outcome for this study was the SF-36© score. Three of the eight SF-36© subscales

(physical functioning, bodily pain and role physical) were considered as main outcomes19 (table

1). Secondary outcomes were seroma formation, wound infection, recurrence, length of hospital

stay in days, aesthetic results, patient satisfaction, operating time in minutes and post-operative

pain.



3

Overall results for quality of life

The scores of the SF-36© subscales in patients treated for incisional hernias are not significantly

lower compared to the matched controls (Table 2). There was no difference between the two

groups; patients scored equal in all subscales. Patients with a history of an open abdominal

treatment did not score significantly lower on the SF-36© compared to patients without such a

treatment.

Karnovsky scale

The median score of KPS was 75 (range 30-90), indicating that activities could be performed with

effort and patients had some signs of disease.

Self-perceived health

Measuring self-perceived health on a 10-point-scale, 80% scored above 6 and 60% scored above

7,5. Scoring overall satisfaction of the surgical procedure, 75% scored above 6 and 50% scored

above 7,5.

Table 2: SF-36© outcome

Study group Controle Group

N mean sd N mean sd t-value p-valuePhysical functioning 69 71,0 24,0 71 74,1 26,8 0,72 0,47Role physical 67 63,4 42,7 71 68,7 41,6 0,73 0,47Bodily pain 69 68,2 24,4 71 68,2 25,4 0,01 0,99General health perceptions 67 61,0 24,1 71 64,3 21,6 0,86 0,39Vitality 69 63,7 21,5 71 64,3 22,4 0,17 0,87Social functioning 69 76,3 27,2 71 81,0 24,6 1,08 0,28Role emotional 65 74,4 39,9 71 75,6 36,9 0,19 0,85Mental health 69 75,8 17,9 71 72,5 20,5 1,01 0,31

Table 3: secondary outcomes; evaluated patients compared to total

patients seen in out-patient clinic n=71 using medical records N=101woundedge necrosis 11 17seroma formation 18 27wound-infection 16 22recurrence 11 unknown

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40 | Chapter 3

Discussion

Incisional hernia is a common complication after abdominal surgery, which causes impressive

morbidity for patients suffering from these hernias, especially when these hernias are large.

Complications like wound healing disorders, seroma, haematoma and mesh removal are more

common after an onlay procedure compared to other techniques (8,10). The quality of life and

chances for re-employment of these patients are reduced (3). It is therefore necessary to find the

best possible solution to treat them.

In the last decade, much research has been done to find the best method to resolve incisional

hernias. Even in a large surgical department as ours, only 10 to 12 onlay procedures are performed

annually, which makes it difficult to evaluate techniques by randomised controlled trials. What

has been proven is that the use of a mesh to correct these hernias is necessary in order to avoid

high recurrence rates (1,10,12). A gold standard for the position of the mesh and how to place it

in the abdomen, i.e open or laparoscopic, is not yet found (3). Although these technical questions

are useful to study, functional outcome and quality of life after hernia repair has become the

more important question.

Disease specific measures focus on a particular health condition and are useful to detect the

changes resulting from a specific treatment. There is currently only one incisional hernia quality-

of-life questionnaire available, named the Carolinas Comfort Scale© (CCS) (7). The CCS is not

validated in Dutch and could, therefore, not be used in our study. Generic measures cover a

broader spectrum of quality-of-life, provide a global assessment of a patient’s overall health and

allow comparisons to other health conditions, different interventions and populations (5). We,

therefore, chose to use the SF-36©.

Generic quality-of-life measurements like the SF-36© are used primarily to compare outcomes

across different interventions and populations. Mesh hernia repair can affect each of the domains

of the SF-36©. Although it is not a disease specific measurement, it is an adequate way to score

HRQL (7,17).

In our study, patients who were treated for an incisional hernia had an equal HRQL score,

measured with the SF-36©, compared to their matched controls. Both groups are matched based

on prevalence of cancer, age and sex. The comparable outcomes of this matched-pair analysis

might be explained partially by the high incidence of cancer (17,18,20,21) as it is known that



3

this has a great influence on the HRQL. Since the questionnaires were filled in anonymously,

it was impossible to perform an individual match. It was, therefore, not possible to perform

a subgroup analysis. Improvement of quality of life through surgery can only be measured by

a validated questionnaire before and after the surgical interference. A prospective study is,

therefore, necessary.

The average outcome of 75 on the KPS shows that patients have some signs of disease and are

able to take care of themselves, but are not always able to carry on normal activity or to do active

work. One patient even scored as low as 30, indicating that (s)he is severely disabled; hospital

admission is indicated although death is not imminent. One could wonder whether this is due to

the hernia correction.

The study by Burger et al. published in 2004 showed that, depending on which surgical method

was used, 64-77% of patients were satisfied after incisional hernia repair (12). The main reason

for dissatisfaction was a recurrent hernia. Of the 181 patients in this trial, 20-23% reported scar

pain and 18-39% suffered bowel pain in the last year. The cosmetic result was satisfying for 47-

52% of the patients (12).

In measuring self-perceived health, 80% of the patients found their overall health status

satisfactory. Scoring general satisfaction of this particular surgical procedure, 75% scored above

6. The recurrence rate was 16% (seven patients). Cosmetic satisfaction is to be examined.

A study published in 2005 using the SF-36© showed improved physical function scores four

months after mesh repair (22). In general, the extent to which postoperative pain interferes

with function has not been well described (7). In this study, six (6%) patients suffered chronic

pain. These patients were specifically asked whether they suffered pain from the numerous skin

staples. Although many patients reported to feel the staples, only 2 patients suffered major pain

due to the staples. One patient chose to have the mesh removed; whether or not this relieved the

pain is not known, as he did not visit the out patient clinic again.

Dietz et al described a classification system in order to subdivide different kinds of incisional

hernias (23,24). They enlist morphology, patient body type and risk factors in the assessment

of prognosis. After classifying different kinds of hernias and studying these groups separately, it

might be easier to make surgical recommendations for these different groups.

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42 | Chapter 3

In this study, 30 patients were lost to follow-up. Although the complication rate was not higher

in this group (table 3), it is possible that their HRQL was worse than in the group which we

evaluated. This might have a positive impact on the outcome of this study. In the attempt to state

something about the HRQOL in patients whose incisional hernia was corrected with an onlay

mesh, we might have to conclude that this group is to small to reject the null hypothesis.

Quality of life is an important but difficult end-point in surgery. Overall, the patients in this study

had significant co-morbidity and also suffered from their incisional hernias. Most of them choose

to have their hernia corrected with this onlay technique because it is fast and simple and allows

a short hospital stay. Although this technique has it disadvantages, it is a very useful in correcting

an incisional hernia in patients who need a uncomplicated and fast procedure. Is it possible that

their expectations influence the level of satisfaction? We do not know. We do not even know if

is relevant. What we do know is that, after incisional hernia correction, 80% of the patients had

a satisfactory health status.

The management of an incisional hernia is currently not standardized (10) and it is probably

not possible to allocate a gold standard for al incisional hernias as a whole. They cannot be

considered as one aetiology. Different types of incisional hernias and different patient groups

need a different treatment approach. In future studies, besides complications and reherniation

rate, HRQOL should be a major endpoint, scored before and after surgical interference.



3

References

1. Cassar K, Munro A. Surgical treatment of incisional hernia. Br J Surg 2002; 89: 534-45.

2. Kingsnorth A, LeBlanc K. Hernias: inguinal and incisional. Lancet 2003; 362: 1561-71.

3. den Hartog D, Dur AH, Tuinebreijer WE, Kreis RW. Open surgical procedures for incisional hernias. Cochrane Database Syst Rev 2008; CD006438.

4. Nieuwenhuizen J, Kleinrensink GJ, Hop WC, Jeekel J, Lange JF. Indications for incisional hernia repair: an international questionnaire among hernia surgeons. Hernia 2008; 12: 223-5.

5. Urbach DR. Measuring quality of life after surgery. Surg Innov 2005; 12: 161-5.

6. Wright JG. Outcomes research: what to measure. World J Surg 1999; 23: 1224-6.

7. Heniford BT et al. Comparison of generic versus specific quality-of-life scales for mesh hernia repairs. J Am Coll Surg 2008; 206: 638-44.

8. Luijendijk RW et al. A comparison of suture repair with mesh repair for incisional hernia. N Engl J Med 2000; 343: 392-8.

9. Vries Reilingh TS et al. Repair of large midline incisional hernias with polypropylene mesh: comparison of three operative techniques. Hernia 2004; 8: 56-9.

10. Korenkov M et al. Classification and surgical treatment of incisional hernia. Results of an experts’ meeting. Langenbecks Arch Surg 2001; 386: 65-73.

11. Korenkov M et al. Randomized clinical trial of suture repair, polypropylene mesh or autodermal hernioplasty for incisional hernia. Br J Surg 2002; 89: 50-6.

12. Burger JW et al. Long-term follow-up of a randomized controlled trial of suture versus mesh repair of incisional hernia. Ann Surg 2004; 240: 578-83.

13. Velanovich V. The quality of quality of life studies in general surgical journals. J Am Coll Surg 2001; 193: 288-96.

14. Kriwanek S et al. Long-term outcome after open treatment of severe intra-abdominal infection and pancreatic necrosis. Arch Surg 1998; 133: 140-4.

15. Scheingraber S, Kurz T, Dralle H. Short- and long-term outcome and health-related quality of life after severe peritonitis. World J Surg 2002; 26: 667-71.

16. van Hanswijck dJ, Lloyd A, Horsfall L, Tan R, O’Dwyer PJ. The measurement of chronic pain and health-related quality of life following inguinal hernia repair: a review of the literature. Hernia 2008.

17. Aaronson NK et al. Translation, validation, and norming of the Dutch language version of the SF-36 Health Survey in community and chronic disease populations. J Clin Epidemiol 1998; 51: 1055-68.

18. Visschers RG et al. Health-related quality of life in patients treated for enterocutaneous fistula. Br J Surg 2008; 95: 1280-6.

19. Bitzer EM, Lorenz C, Nickel S, Dorning H, Trojan A. Patient-reported outcomes in hernia repair. Hernia 2008; 12: 407-14.

20. Kriegsman DM, Deeg DJ, Stalman WA. Comorbidity of somatic chronic diseases and decline in physical functioning:; the Longitudinal Aging Study Amsterdam. J Clin Epidemiol 2004; 57: 55-65.

21. Kriegsman DM, Deeg DJ, van Eijk JT, Penninx BW, Boeke AJ. Do disease specific characteristics add to the explanation of mobility limitations in patients with different chronic diseases? A study in The Netherlands. J Epidemiol Community Health 1997; 51: 676-85.

22. Conze J et al. Randomized clinical trial comparing lightweight composite mesh with polyester or polypropylene mesh for incisional hernia repair. Br J Surg 2005; 92: 1488-93.

23. Dietz UA et al. An alternative classification of incisional hernias enlisting morphology, body type and risk factors in the assessment of prognosis and tailoring of surgical technique. J Plast Reconstr Aesthet Surg 2007; 60: 383-8.

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24. Winkler MS, Gerharz E, Dietz UA. [Overview and evolving strategies of ventral hernia repair.]. Urologe A 2008; 47: 740-7.

Chapter 4

Open abdomen treatment:

planned ventral hernia or delayed fascial closure?

A review of the literature compared with daily practice

M.M. Poelman

H.J. Bonjer

W.H. Schreurs

Submitted

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46 | Chapter 4

Abstract

Introduction Open abdomen treatment is leaving the fascial edges and skin intentionally open after

a laparotomy. The advantages of this treatment are a reduction of the intra-abdominal pressure,

drainage of abdominal cavity and visualization of the intra-abdominal contents postoperatively.

Open abdomen treatment may lead to several serious complications. To prevent evisceration the

open abdomen requires temporary abdominal closure (TAC). The aim of TAC is either delayed

primary fascial closure or development of a ‘planned ventral hernia’. There is no gold standard for

TAC and several techniques are available. Although many studies have evaluated the success rate

of TAC-methods in terms of primary closure rate, little is known about the (long-term) results.

Does delayed fascial closure really benefit the severely ill patient and at what cost should it be

achieved?

The aim of this research was to compare the outcomes of primary fascial closure and planned

ventral hernia after OAT.

Methods Retrospective analysis of our own patients in a large teaching and a university hospital.

Review of the existing literature on OAT and TAC.

Discussion Level 1 and 2 evidence for OAT and the management after this treatment is non-

existent. If OAT is necessary to prevent the patient from dying, the temporary closure should

do the same. The way the abdomen is temporally closed, should not be dependent on the skills

of the surgeon on duty. It has to be a very easy procedure and should not have a large risk of

complications itself. TAC with anticipation of a planned ventral hernia might be a good and

simple option. We plea to keep it simple.


Open abdomen treatment: planned ventral hernia or delayed fascial closure? | 47

4

Introduction

Open abdomen treatment (OAT) is a sometimes necessary but undesirable treatment in severely

ill patients. Intentional opening of the abdominal cavity is a lifesaving procedure in many acute

situations leading to intra-abdominal hypertension and abdominal compartment syndrome. In

case of visceral or retroperitoneal oedema due to shock or reperfusion, the intra-abdominal

pressure may rise to dangerous levels, leading to organ dysfunction. Leaving the abdomen open

allows for visceral and renal perfusion as well as adequate pulmonary function (1).

Open abdomen treatment is leaving the fascial edges and skin intentionally open after a

laparotomy. The advantages of this treatment are a reduction of the intra-abdominal pressure,

drainage of abdominal cavity and visualization of the intra-abdominal contents postoperatively.

Open abdomen treatment is the standard of care in challenging clinical situations that can be

summarized in the following four clinical scenarios. The septic contaminated abdomen that cannot

be closed or when second-look operation is mandatory. The patient with a tense abdomen after

massive resuscitation or a prolonged surgical procedure that is at risk of developing abdominal

compartment syndrome and may be a candidate for prevention.

Open abdomen treatment may lead to several complications such as dehydration, evisceration

and the most serious are the development of enteroatmospheric fistulas and giant ventral hernia,

both associated with prolonged treatment and failure to close the open abdomen.

To prevent evisceration the open abdomen requires temporary abdominal closure (TAC), which is

used to postpone definite closure until predisposing factors causing pathologic elevation of the

intra abdominal pressure or sepsis are resolved. The aim of TAC is either delayed primary fascial

closure or development of a ‘planned ventral hernia’. The ideal TAC stabilizes the abdominal

wall, prevents for lateral retraction of the abdominal wall muscles, minimizes trauma to the skin,

fascia and bowel and is easy to apply, remove and replace. There is no gold standard for TAC and

several techniques are available, including the Bogota bag, absorbable mesh and the KCI VAC

dressing (2) (3).

Although many studies have evaluated the success rate of TAC-methods in terms of primary

closure rate, little is known about the (long-term) results. Does delayed fascial closure really

benefit the severely ill patient and at what cost should it be achieved? What is known about the

long-term results?

The results of a planned ventral hernia are hard to find either: does this treatment negatively

influence the patients’ prognosis? On the long run, should a ventral hernia repair be performed

after the patient recovered or is a conservative management acceptable? And what about quality

of life (QOL) in these patients?

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48 | Chapter 4

The aim of this research was to compare the outcomes of primary fascial closure and planned

ventral hernia after OAT. The incidence and indications for OAT as well as the management of

the abdominal wall after this treatment was started were studied in two hospitals: a university

hospital and a large teaching hospital. Evaluation of the results of our strategy of temporary

closing of the abdomen was performed. Furthermore the management after a ‘planned ventral

hernia’ developed was evaluated.

The literature on OAT was reviewed to find evidence to support a certain temporary abdominal

coverage and a systematic review was performed to see if there is any evidence to advocate a

certain treatment of the abdominal wall after OAT.

Methods

An evaluation of all the patients who had an OAT was done. The selection procedure took place

in two hospitals; a university hospital and a large teaching hospital.

In the both hospitals a search was performed for all patients who were admitted to the Intensive

Care Unit after a laparotomy. The patient files were searched for the following terms: ‘open

abdomen treatment’ and ‘vacuum closure of the abdomen’. The surgical files for the code “re-

exploration of the abdomen, because of post-operative complications” were also selected.

Patients who met all these criteria were included. In the university hospital patients were included

between 2005 and 2010, in the teaching hospital between 2007 and 2010.

Results

Incidence

During this period 2994 laparotomies were performed in both hospitals (1251 in the University

hospital (UH) and 1743 in the Teaching Hospital (TH)).

After laparotomy 883 patients had been admitted to the ICU (264 UH, 559 TH), and all these

files were studied. Finally 55 patients (UH 29, TH 26) met all the criteria and were selected for

evaluation.

Six patients were excluded because there was no follow up; two were transferred to another

hospital after surgery and lost for follow up and four patients died within the first 8 hours after

surgery.



4

Resulting in 49 patients who were included in this study: 21 females and 28 males. Mean age at

time of surgery was 70 years for females and 62 years for males. Eleven patients died during the

hospital admittance. Patients’ characteristics are listed in table 1. The mean length of hospital stay

was 42,5 days (table 2).

Table 1: baseline characteristics

Patient characteristics Number ExtremesGender male/female 28/22Age (mean) 65,82Cardiac disease(s) 32%Pulmonary diseases/smokers 36%Malignancy 34%BMI (mean) 25,80 16,2 - 41,52Corticosteroid use 5%Diabetes 12%

Table 2: results

Results N= Days ExtremesDeaths during admittance 11Length of hospital stay (mean) 65,5 42,5 3 - 245Length of stay in ICU 22,8 22,7 1 - 86

Indications

These patients were all reported ASA 3, 4 and 5 according to the ASA physical status classification.

Most patients required an acute surgical intervention because of sepsis and/or shock. There were

various reasons why the fascia could not be closed (table 3); anastomotic dehiscence frequently

caused abdominal sepsis and/or an abdominal compartment syndrome. In some patients a known

bowel perforation was put underneath a Vicryl mesh and the fascia was left open to drain the

abdominal cavity. Damage control surgery has not been reported.

Table 3: Causes of open abdomen treatment

Indication for Open Abdomen Treatment N=Abdominal sepsis after anastomotic dehiscence 20Short bowel perforation (iatrogenic and spontaneous) 8Bowel ischemia due to vascular occlusion 4ACS due to bleeding 5Fascial dehiscence 5Other 7

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50 | Chapter 4

Management of the open abdomen

In all but two patients temporary closure was achieved with an absorbable mesh i.e. Vicryl. The

mesh was sewn at the fascial edges or stapled onto the skin if the fascia tensile strength was to

low. A Vacuum system and a Bogota bag were both only used once.

Mortality and morbidity rate

There were 13 patients with entero-atmospheric fistulas: Eight patients developed fistulas after

the OAT was started, in 5 patients an OAT was started because of the fistula formation. Sixteen

patients were treated for intra-abdominal abscesses after the OAT was started. Eleven patients

died during their hospital stay, 4 died within 48 hours after the OAT was started. Causes of death

were: 7 sepsis, 2 intra-abdominal bleeding, 1 myocardial infarction, 1 necrotizing pancreatitis.

Follow up

Of the 49 patients, 11 died during hospital stay: cause of death was due to their initial disease. Of

the remaining 38 patients, 19 patients did not have a ventral hernia repair until now. Of the 19

patients that did have a surgical incisional hernia repair, 9 were reconstructed using a large onlay

mesh, we reported on these patients earlier (6). Five patients had a primary suture closure (all

after planned closure of their ileostomy or colostomy), two had a Ramirez, one had a sublay repair

and one had an inlay repair. Of these 19 patients, three recurrences were reported in the follow-

up: one after the onlay mesh repair, one after primary suture closure and one after sublay repair.

The patients still alive were contacted to ask them about their quality of life. We specifically

asked them if they still had problems concerning their abdominal wall. Five patients were lost for

follow up because they died of other causes in the mean time. Twenty-seven of the 31 patients

responded (table 4).

As table 4 shows, no difference between the patients who had and the patients who hadn’t

a correction of the incisional hernia could be demonstrated. The patients equally dislike their

abdominal wall appearance and still have the same wish for surgical interference. Patients without

surgical correction tend to have more incarceration of bowel in the hernia, however with these

small numbers of patients, statistical significance cannot be reached.

Table 4: Follow-up

After incisional hernia repair. N=14 After conservative treatment. N=13VAS score (mean) 2 (0-7) 1 (0-7)Use of a bondage 3 2Incarceration of a bowel 1 4Cosmetics; unhappy with the result 12 11Wish for surgical repair 5 5



4

Discussion

Incidence

Little is known about the incidence of open abdomen treatment. Some articles suggest that 25%

of all patients who undergo a laparotomy because of a trauma will be treated with a (temporary)

open abdomen, according to the damage control principle (4).

Leaving the abdomen open because of a damage control purpose however is thought to be

another aetiology than an OAT because of sepsis or ACS. It has been shown that trauma patients

whose abdomen was left open were more likely to have primary fascial closure (5). Nevertheless,

these groups of patients are frequently studied together. In our study we found an incidence of

less than 2% (UH 1.9%, TH 1.5%,) of all performed laparotomies during the study period.

A single centre study from England, reports only 29 patients in 6 years whose abdominal walls

were left open because of sepsis (6). A Swedish study reports 151 patients with an open abdomen

treatment (for more than five days; the majority because of sepsis or ACS) in 4 hospitals within

41 months (7). Prichayudh et al reported only 37 patients, with sepsis or ACS, who had an open

abdomen treatment in over 6 years in a Thai hospital (8). Other retrospective studies do not

specifically search for patients treated with an open abdomen, but search for the device chosen

to treat their open abdomen, for example, the use of a Vacuum-dressing (9) (10). Studies on the

number of patients requiring OAT according to the number of performed laparotomies were not

found.

Temporary abdominal closure

OAT is mend to be a live saving procedure, however, once the abdomen is left open a potentially

dangerous situation is created for the individual patient. Early complications of an open abdomen

treatment are increased water and electrolyte loss, evisceration and entero-cutaneous fistula

formation. Late complications are entero-cutaneous fistula formation, lateral retraction of the

fascial edges and development of a large ventral hernia (6). The last one is rather a consequence

than a complication, as it is not an adverse or unforeseen effect. Entero-cutaneous or entero-

atmospheric fistula formation is the most severe complication.

Therefore temporally closure is demanded. The aim of the abdominal coverage is to make

sure that the abdominal content stays inside, to allow for drainage, to keep the fascial edges

together and to prevent the formation of adhesions between the viscera and the abdominal

wall. Furthermore, the coverage should not damage the viscera underneath it and should be

easy to apply and remove. The temporary closure may facilitate delayed primary fascial closure,

this is however not the main goal. If the plan for delayed closure fails, a ‘planned ventral hernia’

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52 | Chapter 4

is created. Articles examining the different temporary abdominal coverages are widely available

however, they tend to differentiate for the cause of the open abdomen treatment and usually

study small numbers (3).

A method to cover and protect a laparotomy wound is the application of a Bogota-bag. A Bogota

bag is a sterile plastic bag used for closure of abdominal wounds. It is generally a sterilized, 3 liter

genitourinary irrigation bag that is sewn to the skin or fascia of the anterior abdominal wall. Its

use was first described by Oswaldo Borraez while a resident in Bogota, Colombia.

This method is cheap, easy to use and always available. Disadvantage is it does not prevent the

fascia to shift laterally. The Bogota bag is very popular in the treatment of gastroschisis in new-

born.

Another method to cover the open abdomen is the use of a mesh. Absorbable meshes have

been used for many years to close the abdomen. They are easy to handle, widely available and

resistant to infection. An absorbable mesh allows for the development of a ‘planned ventral

hernia’ when a delayed primary fascial closure cannot be achieved. The disadvantage of the

use of an absorbable mesh is the risk for entero-atmospheric fistula formation (11). The risk is

reported to be up to 7% but is also related to the severity of the abdominal injury. Advantage of

an absorbable mesh is that it can be left in situ.

The third method to cover an open abdomen is the use of a Vacuum system. The technique has

first been reported in the mid-eighties and has evaluated since (12). A non-adherent plastic drape

is placed beneath the anterior abdominal wall to protect the viscera. Coverage is created with the

use of sponges and drapes, and a controlled sub-atmospheric pressure is connected to a small

opening in the drape. This technique facilitates the removal of fluid collections, reduces oedema

and accelerates healing by the formation of granulation tissue. It is a widely used technique that

gained popularity in the last decade. Is thought to be associated with the highest rates of delayed

primary fascial closure and the lowest mortality rates, yet this is only level IV evidence (7).

The latest modification is the combination of a mesh with a vacuum system (13) (14) (7). These

studies report a high fascial closure rate, however patients had to be taken into the operation

room every other day to change the vacuum system en tighten the mesh (14). Complications

like fistula formation occurred in about 5%. Both last mentioned procedures are also technically

demanding when ileo- or colostomies are present.

The results after delayed primary fascial closure are unknown. Most studies choose the achieved

fascial closure rate as endpoint of their research. Morbidity and mortality is unknown as are

success rates and failures resulting in an incisional hernia. Follow-up in these studies is non-

existing or very short.



4

Delayed fascial closure or ‘planned ventral hernia’?

When delayed primary closure of the fascia is not achieved, a ventral hernia exists. A split skin

graft is sometimes used to close the defect when granulation tissue is present. Some patients

might want to have this hernia repaired. Several techniques are known to repair large incisional

hernias, such as a modified component separation technique, onlay and sublay procedures (15)

(16) all with the use of a synthetic mesh. The overall results of all surgical techniques are at

best moderate; recurrence rates up to 30% have been reported and complications like wound

infections frequently occur.

There is no study reporting the conservative treatment of the ‘planned ventral hernia’. Patients

might be fine once the abdominal wall has recovered and scar tissue might be strong enough to

keep the abdominal content into place. The use of bondage can also help these patients.

Quality of life (QOL) is a major endpoint in evaluating surgical techniques; however, only few

studies concerning the reconstruction of large ventral hernias included QOL questionnaires (17).

QOL in patients with a large ventral hernia who are treated conservatively is unknown.

OAT is a known treatment in case of ACS and in damage control surgery. Patients who had an

open abdomen treatment are often compared with patients with large ventral hernias, while we

believe this is a different modality.

Once the abdomen has been left open, the choice of a temporary abdominal closure depends on

the planned treatment strategy. When the surgeon aims for delayed fascial closure, the use of a

vacuum system is thought to give the highest chance of a successful closure. As a consequence,

patients have to undergo surgery every other day. If delayed primary fascial closure can be

obtained, the long-term results for developing an incisional hernia are unknown.

Frequent surgical intervention can be too invasive for critically ill and/or aged patients. In that

case achieving primary fascial closure is, or should not be the main goal and thus an absorbable

mesh is used. The mesh is easy to handle, allows for drainage and prevents the fascial edges to

shift too laterally. Using an absorbable mesh, a planned ventral hernia can be created, while the

patient recovers.

Patients with a planned ventral hernia may need a surgical correction, although conservative

management can be a good option to. Indications for surgical repair are usually pain, bowel

obstruction or aesthetic complaints. Conservative management has never been reported, so the

non-surgical treatment of large ventral hernias is unknown. Quality of life in this patient group

has not been evaluated. In our study no difference was found between the two patients groups

according to patient satisfaction, pain and cosmetics.

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54 | Chapter 4

Conclusion

Level 1 and 2 evidence for OAT and the management after this treatment is non-existent. In

general, the indications for open abdomen treatment are known; i.e. ACS and damage control.

Once the fascia has been left open, the temporary coverage can be done using an absorbable

mesh, a vacuum system or a combination of both.

If OAT is necessary to prevent the patient from dying, the temporary closure should do the same.

The way the abdomen is temporally closed, should not be dependent on the skills of the surgeon

on duty. It has to be a very easy procedure and should not have a large risk of complications

itself. The first goal should be survival of the severely ill patient. The use of an absorbable mesh

stapled to the skin or sewn at the fascia is a simple procedure and does not dependent on the

skills of the individual surgeon. Until evidence is available to advocate another procedure, we

therefore plea to keep it simple. If a patient survives, a reconstruction of the abdominal wall may

be necessary. However, a conservative treatment might be a good option to. For now options

should be discussed with the patient and treatment should be personalized. Further research is

necessary on how to manage patients with OAT. Survival and QOL should be major endpoints.



4

References

1. Schein M, Ivatury R. Intra-abdominal hypertension and the abdominal compartment syndrome. Br J Surg 1998, Aug;85(8):1027-8.

2. Stevens P. Vacuum-assisted closure of laparostomy wounds: A critical review of the literature. Int Wound J 2009, Aug;6(4):259-66.

3. Boele van Hensbroek P, Wind J, Dijkgraaf MG, Busch OR, Goslings JC, Carel Goslings J. Temporary closure of the open abdomen: A systematic review on delayed primary fascial closure in patients with an open abdomen. World J Surg 2009, Feb;33(2):199-207.

4. Miller PR, Meredith JW, Johnson JC, Chang MC. Prospective evaluation of vacuum-assisted fascial closure after open abdomen: Planned ventral hernia rate is substantially reduced. Ann Surg 2004, May;239(5):608-14; discussion 614-6.

5. Tsuei BJ, Skinner JC, Bernard AC, Kearney PA, Boulanger BR. The open peritoneal cavity: Etiology correlates with the likelihood of fascial closure. Am Surg 2004, Jul;70(7):652-6.

6. Anderson O, Putnis A, Bhardwaj R, Ho-Asjoe M, Carapeti E, Williams AB, George ML. Short- and long-term outcome of laparostomy following intra-abdominal sepsis. Colorectal Dis 2011, Feb;13(2):e20-32.

7. Acosta S, Bjarnason T, Petersson U, Pålsson B, Wanhainen A, Svensson M, et al. Multicentre prospective study of fascial closure rate after open abdomen with vacuum and mesh-mediated fascial traction. Br J Surg 2011, Jan 14.

8. Prichayudh S, Sriussadaporn S, Samorn P, Pak-Art R, Sriussadaporn S, Kritayakirana K, Capin A. Management of open abdomen with an absorbable mesh closure. Surg Today 2011, Jan;41(1):72-8.

9. Fieger AJ, Schwatlo F, Mündel DF, Schenk M, Hemminger F, Kirchdorfer B, et al. [Abdominal vacuum therapy for the open abdomen - a retrospective analysis of 82 consecutive patients]. Zentralbl Chir 2011, Feb;136(1):56-60.

10. Caro A, Olona C, Jiménez A, Vadillo J, Feliu F, Vicente V. Treatment of the open abdomen with topical negative pressure therapy: A retrospective study of 46 cases. Int Wound J 2011, Jun;8(3):274-9.

11. Mayberry JC, Burgess EA, Goldman RK, Pearson TE, Brand D, Mullins RJ. Enterocutaneous fistula and ventral hernia after absorbable mesh prosthesis closure for trauma: The plain truth. J Trauma 2004, Jul;57(1):157-62; discussion 163-3.

12. Padalino P, Dionigi G, Minoja G, Carcano G, Rovera F, Boni L, Dionigi R. Fascia-to-fascia closure with abdominal topical negative pressure for severe abdominal infections: Preliminary results in a department of general surgery and intensive care unit. Surg Infect (Larchmt) 2010, Dec;11(6):523-8.

13. Seternes A, Myhre HO, Dahl T. Early results after treatment of open abdomen after aortic surgery with mesh traction and vacuum-assisted wound closure. Eur J Vasc Endovasc Surg 2010, Jul;40(1):60-4.

14. Petersson U, Acosta S, Björck M. Vacuum-assisted wound closure and mesh-mediated fascial traction--a novel technique for late closure of the open abdomen. World J Surg 2007, Nov;31(11):2133-7.


16. Poelman MM, Langenhorst BL, Schellekens JF, Schreurs WH. Modified onlay technique for the repair of the more complicated incisional hernias: Single-centre evaluation of a large cohort. Hernia 2010, Aug;14(4):369-74.

17. Zarzaur BL, DiCocco JM, Shahan CP, Emmett K, Magnotti LJ, Croce MA, et al. Quality of life after abdominal wall reconstruction following open abdomen. J Trauma 2011, Feb;70(2):285-91.

Chapter 5

The INCH-Trial: a multicenter randomized controlled trial

comparing the efficacy of conventional open surgery and

laparoscopic surgery for incisional hernia repair

Poelman M

Apers J

van den Brand H

Cense H

Consten E

Deelder J

Dwars B

van Geloven N

de Lange E

Lange J

Simmermacher R

Simons M

Sonneveld E

Schreurs H

Bonjer J

BMC Surgery 2013 13:18 (7 June 2013)

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58 | Chapter 5

Abstract

Background Annually approximately 100.000 patients undergo a laparotomy in the Netherlands.

About 15,000 of these patients will develop an incisional hernia. Both open and laparoscopic

surgical repair have been proven to be safe. However, the most effective treatment of incisional

hernias remains unclear. This study, the ‘INCH-trial’, comparing cost-effectiveness of open and

laparoscopic incisional hernia repair, is therefore needed.

Methods / Design A randomized multi-center clinical trial comparing cost-effectiveness of open

and laparoscopic repair of incisional hernias. Patients with a symptomatic incisional hernia,

eligible for laparoscopic and open incisional hernia repair. Only surgeons, experienced in both

open and laparoscopic incisional hernia repair, will participate in the INCH trial. During incisional

hernia repair, a mesh is placed under or on top of the fascia, with a minimal overlap of 5 cm.

Primary endpoint is length of hospital stay after an incisional hernia repair. Secondary endpoints

are time to full recovery within three months after index surgery, post-operative complications,

recurrences, mortality and quality of life.

Our hypothesis is that laparoscopic incisional hernia repair comes with a significant shorter

hospital stay compared to open incisional hernia repair. A difference of two days is considered

significant. One-hundred-and-thirty-five patients are enrolled in each treatment arm. The

economic evaluation will be performed from a societal perspective. Primary outcomes are costs

per patient related to time-to-recovery and quality of life.

The main goal of the trial is to establish whether laparoscopic incisional hernia repair is superior

to conventional open incisional hernia repair in terms of cost-effectiveness. This is measured

through length of hospital stay and quality of life. Secondary endpoints are re-operation rate due

to post-operative complications or recurrences, mortality and quality of life.

Discussion The difference in time to full recovery between the two treatment strategies is thought

to be in favor of the laparoscopic incisional hernia repair. Laparoscopic incisional hernia repair is

therefore thought to be a more cost-effective approach.


The INCH-Trial: a multicenter randomized controlled trial comparing the efficacy of conventional open | 59

5

Introduction

Incisional hernias are defects of the fascia of the abdominal wall, covered by skin, which can

develop after abdominal surgery. Bulging through the scar is visible and palpable when patients are

standing or coughing (1-2). These hernias occur in at least 15% of patients after open abdominal

surgery within ten years after surgery. Incisional hernias may be asymptomatic, but frequently

they cause pain and give aesthetic complaints. They can also cause serious complications like

strangulation of the bowel. The quality of life in these patients as well as their chances for

employment is reduced (2).

Pre-disposing factors to get an incisional hernia are obesity, which is increasing rapidly in the

Western world, and a post-operative surgical site infection (3). There are no differences between

men and women in developing an incisional hernia. Ethnical differences are not known. The

pathogenesis of incisional hernias is complex; altered collagen metabolism and extra-cellular

matrix disorders causing wound-healing disorders have been found in patients who developed

incisional hernias (4).

A population based study showed a 3,7% yearly increase in the incidence of incisional hernia repair

per 10.000 people (5) in the United States. Since obesity plays an important role in developing

an incisional hernia and is an increasing problem in the Netherlands, we expect the incidence of

incisional hernias to increase in the Netherlands as well. Mean age at time of the surgical repair is

58 years old; mean SD 15 years (6). The majority of these patients will have to go back to work.

Eighty per cent of the patients with an incisional hernia undergo surgical repair (5). The

morbidity of open incisional hernia repair is more than 20% involving recurrence and mesh

infection. Laparoscopic surgery tends to be safe and is associated with less infections and shorter

hospitalization. It is highly feasible in obese patients, because of a good exposure of the incisional

hernia. However, the surgical procedure can be difficult and the operating time might be longer.

Up till now it is not clear what is the best treatment strategy for incisional hernias. The potential

benefits of a more defined treatment strategy includes a shorter hospital admission, cost reduction

and less post-operative complications.

Two recent meta-analysis (7,8) state that laparoscopic repair is at least as effective and might be

superior to the open approach in a number of outcomes. Total hospital stay was shorter and less

post-operative complications were seen. The largest study in the meta-analysis (8) has several

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60 | Chapter 5

shortcomings; randomization is not listed and there was no sample size calculation. Most studies

only provide short-term follow-up evaluation and cost-effectiveness is not evaluated. This study,

comparing the cost-effectiveness of open and laparoscopic incisional hernia repair, is therefore

needed.

Criteria to recommend a surgical repair should be stated and the natural course of an incisional

hernia should be examined.

This is a multi-centre study with surgeons who are experienced in open as well as laparoscopic

surgery. The study group exists of dedicated laparoscopic surgeons, committed to improve hernia-

care. First, we want to know if laparoscopic repair is more effective than open repair. The future

of this study will allow evidence-based change of practice.

Methods / Design

A randomized multi-centre trial comparing the cost-effectiveness of two surgical techniques for

the repair of incisional hernias: laparoscopic vs. conventional open repair.

Inclusion criteria:

The following patients will be eligible for the randomization to either open or laparoscopic repair:

Adult patients who are referred to the surgical clinic for assessment of an incisional hernia, either

primary or recurrent. Imaging of the abdomen will only be done when it is unclear whether an

incisional hernia is present. The need for surgery will be determined; pain, severe discomfort

and episodes of visceral incarceration are indications for surgery. Only symptomatic patients will

get a surgical correction of the incisional hernia. Patients whose incisional hernia is suitable for

laparoscopic repair are included in the trial, this decision is at the discretion of the surgeon.

After consenting to the study, the patient will be randomized to either open or laparoscopic

repair. Patients who are excluded or who don’t want to participate will be registered. (figure 1;

flowchart).



5

patients with an incisional hernia

symptomatic

elegible for randomisation

laparoscopic incisional hernia

repairopen incisional hernia repair

excluded patients. register patient in

the databse

asymptomatic

register patient in the database

Figure 1: flowchart.

Exclusion criteria:

1. Pregnancy

2. Age less than 18 years old 18

3. Abdominal ostomy

4. History of open abdomen treatment

5. Mentally or cognitively unable to be consented

6. A life expectancy of less than one year

7. Immune-compromised patients

8. ASA>3 (ASA: scoring system of the American Society of Anaesthesiologists)

Treatment:

Patients will be randomized, using a computer-program, to one of the following surgical

approaches:

I) Open repair of the incisional hernia: the employed open technique is at the discretion of the

participating surgeon. There is no evidence, which open technique, is best; bridging as well as

augmenting techniques might be used. Onlay, sublay as well as CST technique are allowed as

long as a mesh is used. An overlap of at least 5cm of the mesh over the fascia is preferable.

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62 | Chapter 5

II) Laparoscopic repair of incisional hernias will entail employment of mesh that is placed

subfascially with a minimal overlap of 5cm. Choice and fixation of the mesh is at the discretion

of the surgical team. During laparoscopic surgery a photograph will be taken of the hernia defect

before and after the correction is done. When laparoscopic repair is not successfully achieved

or complications occur, the surgeon may decide to change to the open surgical procedure (i.e.

conversion); this is common practice in laparoscopic surgery.

In each approach, the use of a mesh is preferable, as this has shown to reduce the recurrence-

rate (9). Every detail of the technique should be described. Dutch hernia experts will perform the

surgical corrections.

Case Record Form:

At first presentation in the outpatient clinics: age/ sex/ co-morbidity/ pre-illness/ working-social

activities/ surgical history/ symptoms of the incisional hernia/ classification of the incisional hernia:

The European Hernia Society (EHS) tried to categorize incisional hernias, in order to be able to

compare different scientific incisional hernia research (10). A classification system of abdominal

wall hernias was formulated (figure 2). This classification will be used in the INCH-trial.

Postoperatively: open or laparoscopic/ length of the scar/ duration of surgery/ type of mesh used/

size of the mesh/ type of mesh fixation/ presence of bleeding/ accidental bowel lesion/ use of

tubes/ use of per-operative antibiotics/ possible re-operation.

Inpatient: daily VAS score/ use of analgesics/ length of hospital stay/ morbidity/ mortality/ QOL at

two days post-surgery.

During Follow-up at 2 weeks and 3 months: healthcare and lost productivity costs/ QOL at 2

weeks and 3 months post-surgery will be measured through the Short Form 36 and the Carolina

Comfort Scale/ time to return to work/ recurrence/ pain/ wound infection/ patient satisfaction/

other morbidity.

During long-term follow-up at 1, 3 and 5 years: Recurrence/ pain/ wound infection/ patient

satisfaction/ other morbidity.



5

54

Figure 2

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64 | Chapter 5

Primary outcomes

--Length of hospital stay. This is the time until discharge. A patient can be discharged when he/

she is able to move normally, tolerate a normal diet and has a VAS painscore< 5 without the use

of opiates.

--Quality of life measures through SF-36 and CCS.

Secondary endpoints

-Re-operation rate for recurrence or complications of the incisional hernia repair. The analysis

will be continued after the cost-effectiveness study has ended, a longer follow-up is needed to

examine the recurrence-rate.

-28 days post surgery morbidity and mortality,

-Shape of the abdomen: a digital photograph of the abdomen using raster-stereography will be

taken pre- and post-operatively to analyse the change in the abdominal shape.

-Total mean costs will be related to the following effect measures in the cost-effectiveness

analyses:

1) Time to full recovery

2) Quality-adjusted life-years (QALYs) based on the SF-36D(11)

Intention to treat analysis will be performed. Blinding is impossible as the surgical difference is

visible from the outside.

Economic evaluation

The aim of the economic evaluation is to describe the costs of laparoscopic and open repair of

incisional hernias, and to relate the costs to the clinical effects of the treatments. The time horizon

of the economic evaluation is 3 months. A societal perspective is chosen for this economic

evaluation. For the measurement and valuation of the costs the Dutch costing guidelines will be

used (12).

Cost measurement and valuation Health care utilization will be measured using hospital data

and cost diaries during hospitalization and after 2 weeks and 3 months of follow-up. Health care

costs include costs of the operation, hospital stay, medical supplies, additional examinations (CT,

X-ray, laboratory, etcetera), medication, GP care, emergency visits and ambulatory hospital care.

Absenteeism from paid and unpaid work and presenteeism at baseline and after 2 weeks and 3

months of follow-up will also be measured.



5

For the valuation of health care utilization standard prices published in the Dutch costing

guidelines will be used (12). Medication use will be valued using prices of the Royal Dutch

Society for Pharmacy. A detailed cost price calculation will be performed to estimate the costs of

laparoscopic and open repair of incisional hernias.

Analysis of cost-effectiveness

The analysis will be done according to the intention-to-treat principle. Missing cost and effect

data will be imputed using multiple imputations according to the MICE algorithm developed

by Van Buuren (13). Costs typically have a highly skewed distribution. Policy makers want to

have information on the difference in mean total costs between the two treatment-groups to

be able to estimate the total health care budget needed for a specific condition (14). Therefore,

bias-corrected and accelerated bootstrapping with 5000 replications will be used to calculate

95% confidence intervals around the mean difference in total costs between the treatment

groups. Incremental cost-effectiveness ratios (ICERs) will be calculated by dividing the difference

in mean total costs between the treatment groups by the difference in mean effects between the

treatment groups. Bootstrapping will be used to estimate the uncertainty surrounding the ICERs,

which will be graphically presented on cost-effectiveness planes. Cost-effectiveness acceptability

curves and net monetary benefits will also be calculated. Cost-effectiveness acceptability curves

show the probability that collaborative care is cost-effective in comparison with usual care for a

range of different ceiling ratios thereby showing decision uncertainty (15).

The baseline data of both treatment groups will be described and 95% confidence intervals will

be calculated. Additional as-treated analyses will be done, because patients who were planned

to have a laparoscopic repair might have had an open correction and vice versa. Differences in

primary and secondary endpoints between the two treatment groups will be calculated as well

as their 95% confidence intervals. Student’s t tests, Chi square tests or Fisher exact tests will

be applied where appropriate. The risk of re-operation will also be studied by application of a

multiple logistic regression model.

Statistics

Sample size calculation: This is a superiority design: Our hypothesis is that length of hospital stay

is shorter after incisional hernia repair, and therefore the laparoscopic approach will be superior

in terms of cost-effectiveness. Statistics are based on an average hospital stay of 2 days (SD 5)

after laparoscopic repair (8). The outcome is considered superior if there is a difference in hospital

stay of more than 2 days. Therefore, 135 patients in each treatment arm are needed (alpha

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66 | Chapter 5

0,05/ power 0,9) (16). Loss to follow-up may occur; we will therefore aim for an inclusion of 300

patients.

Randomisation will be performed through a computer-guided system. A stratified block-

randomisation will be used per centre. The randomisation code will be noted on the patients file.

Peritonitis carcinomatosa, unplanned surgical procedures for pathology that was not discovered

during pre-operative analysis, absence of an incisional hernia are reasons for post-randomization

exclusion.

Feasibility

Twelve hospitals, both university medical centres and community hospitals, will participate in this

trial. The study group consists of hernia experts from these 12 centres, who frequently perform

laparoscopic as well as open hernia surgery. These hospitals perform about 20-30 incisional

hernia corrections a year, and aim for an inclusion of 10-15 patients each year.

We aim for 125 patients per year, hence 12-13 inclusions every month. This is highly feasible,

because these 12 centres together perform over 300 incisional hernia repairs annually. We aim

for participation of more centres along the way, but only experienced laparoscopic surgeons can

participate.

Time schedule

Study preparation and formation of a core study group is already in progress. Initiation of the

INCH-trial around 1-8-2012 after METC permission is obtained in each hospital. We aim for an

inclusion rate of 10-15 patients per month. About 28 months are needed to include the amount

of patients needed to calculate the difference in length of hospital stay. After this period the trial

will continue; to meet the secondary end-point a longer follow-up period is needed. The follow-

up will be continued at 3 and 5 year after index surgery. Patients who don’t want to participate

and patient who are excluded will be registered.

Ethical approval and safety monitoring

According to the ‘Good Clinical Practice’ rules, ethical approval has been asked and obtained

from our Medical Ethical Board (METC). This independent board will supervise the trail and make

decisions about all possible changes in the study through amendments. The board will also

monitor the possible complications.



5

No experimental surgery is performed; all the surgical techniques used are already part of our

daily practice. All hospitals record (post-operative) morbidity according to guidelines of the Dutch

Society of Surgeons. Adverse effects will be registered and told to the METC.

SAE’s All individual Serious Adverse Events (SAE’s) will be registered and reported to the CCMO.

Sepsis and possible re-operation due to a missed bowel perforation after laparoscopic incisional

hernia repair, as well as death in the direct post-operative phase will be reported within 7 days.

Permission has been obtained for ‘line listing’ for all other individual SAE’s; the METC permits to

report all other events once every 6 months.

Criteria for participating centres Participating surgeons have already performed at least 50 open

and 50 laparoscopic incisional hernia repairs. They will hand over an unedited recording of a

laparoscopic incisional hernia repair of their own. The principle investigators will review their

recordings. Guidelines to perform a safe laparoscopic procedure will be made. Participating

surgeons have to follow the guidelines.

Goal

The goal of the trial is to establish whether laparoscopic incisional hernia repair is superior to

conventional open incisional hernia repair in terms of cost-effectiveness. This is measured through

length of hospital stay and quality of life. Secondary endpoints are re-operation-rate (due to

complications or recurrence), morbidity, mortality and shape of the abdomen.

In current surgical practice there is on going discussion about the possible benefits of laparoscopic

incisional hernia surgery. Scientific evidence is lacking to determine whether laparoscopic

correction is superior to conventional open techniques in terms of cost-effectiveness.

Discussion

The difference in time to full recovery between the two treatment strategies is thought to be in

favor of the laparoscopic incisional hernia repair. Laparoscopic incisional hernia repair is therefore

thought to be a more cost-effective approach.

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68 | Chapter 5

References

1. Cassar K, Munro A. Surgical treatment of incisional hernia. Br J Surg 2002; 89: 534-45.

2. Den Hartog D, Dur AH, Tuinebreijer WE, Kreis RW. Open surgical procedures for incisional hernias. Cochrane Database Syst Rev 2008 jul 16;(3):CD006438.

3. Llaguna OH, Avgerinos DV, Lugo JZ, Matatov T, Abbadessa B, Martz JE, Leitman IM. Incidence and risk factors for the development of incisional hernia following elective laparoscopic versus open colon resections. Am J surg aug 2010 Aug;(200)2: 265-269.

4. Rosch R, Junge K, Knops M, Lynen P, Klinge U, Schumpelick V. Analysis of collagen-interacting proteins in patients with incisional hernias. Ach surg 2003 vol 387;427-432.

5. Nieuwenhuizen J, Kleinrensink GJ, Hop WC, Jeekel J, Lange JF. Indications for incisional hernia repair: an international questionnaire among hernia surgeons. Hernia 2008; 12: 223-5.

6. Flum DR, Horvath K, Koepsell T. Have outcomes of incisional hernia repair improved with time? Annals of surgery 2003; vol 237, No 1, 129-135.10.

7. Forbes SS, Eskicioglu C, McLeod RS, Okrainec A. Meta-analysis of randomized controlled trials comparing open and laparoscopic ventral incisional hernia repair with mesh. Br J Surg 2009; 96: 851-858.

8. Sajid MS, Bokhari SA, Mallick AS, Cheek S, Baig MK. Laparoscopic versus open repair of incisional/ventral hernia: a meta-anaysis. Am J Surg 2009: 197: 64-72.

9. Luijendijk RW, Hop WCJ, van den Tol MP, de Lange DCD, Braaksma MMJ, IJzermans JNM, Boelhouwer RU, de Vries BC, Salu MKM, Wereldsma JCJ, Bruijninckx DCMA, Jeekel J. A comparison of suture repair with mesh repair for incisional hernia. N Engl J Med 2000; 343: 392-8.

10. Muysoms FE, Miserez M, Berrevoet F, Campanelli G, Champault GG, Chelala E, Dietz UA, Eker HH, El Nakadi I, et al. Classification of primary and incisional abdominal wall hernias. Hernia 2009;13:407–414.11.

11. Brazier J, Robert J, Deverill M. The estimation of a preference-based measure of health from the SF-36. J Health Econ 2002 Mar;21(2):271-92.

12. Oostenbrink, J. B., Bouwmans, C. A. M., Koopmanschap, M. A., and Rutten, F. F. H. Handleiding voor kostenonderzoek: Methoden en standaard kostprijzen voor economische evaluaties in de gezondheidszorg. Geactualiseerdeversie 2004 [Handbook for cost studies: methods and standard costs for economic evaluation in health care. Updatedversion 2004. Den Haag, The Netherlands: College voor Zorgverzekeringen; 2004.

13. vanBuuren, S. and Oudshoorn, C. G. M. Multivariate Imputation by Chained Equations. Leiden: TNO;2000.

14. Thompson SG, Barber JA. How should cost data in pragmatic randomised trials be analysed? BMJ 2000 Apr 29;320(7243):1197-200.

15. Fenwick E, Byford S. A guide to cost-effectiveness acceptability curves. Br J Psychiatry 2005 Aug;187:106-8.

16. Dupont WD, Plummer WD. Power and Sample Size Calculations forStudies Involving Linear Regression. Controlled Clinical Trials 1998; 19:589-601.

Chapter 6

Comparison of the Dutch and English version of the

Carolinas Comfort Scale; a specific quality of life-

questionnaire for abdominal hernia repairs with mesh

K Nielsen

MM Poelman

FM den Bakker

HJ Bonjer

WH Schreurs

Hernia 2013 Oct 29

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70 | Chapter 6

Abstract

Purpose Repair of abdominal wall hernias with mesh is one of the most common procedures in

general surgery. The introduction of hernia repair with mesh has lowered recurrence rates and

shifted the focus to quality of life after surgery, raising the need for a specific tool measuring

quality of life. The Carolinas Comfort Scale (CCS) is a questionnaire designed specifically for

patients having hernia repair with mesh. The aim of this study is to validate the Dutch CCS and

to compare it to the generic short-form-36 (SF-36).

Methods The CCS questionnaire was translated into Dutch. Patients undergoing mesh hernia

repair between April 2010 and December 2011 completed the CCS, the SF-36 and 4 questions

comparing these two questionnaires in the first week after surgery. After three weeks, the CCS

was repeated. Correlations between the two surveys were calculated using the Spearman’ s rank

correlation test with a 95% confidence interval to determine validity.

Results The response rate was 60.3% (100/168). The CCS showed excellent reliability

with a Crohnbach’s α of 0.948. Significant correlation existed between the CCS and the

domains physical functioning, bodily pain, role physical, vitality and social functioning of

the SF-36. Seventy-nine percent of the patients preferred the CCS to the SF-36, and 83%

considered the CCS a better reflection of their quality of life after hernia repair with mesh.

Conclusion The Dutch CCS appears a valid and clinically relevant tool for assessing quality of life

after repair of abdominal wall hernia with mesh.


Comparison of the Dutch and English version of the Carolinas Comfort Scale; a specific quality of life-questionnaire | 71

6

Introduction

Surgical repair of inguinal, umbilical and incisional hernias is the most common procedure in

general surgery. Annually, more than 20 million groin hernias (inguinal and femoral) are repaired

worldwide, with a respective lifetime risk of 27% and 3% in men and women (1;2). Umbilical

hernias account for 10% of all primary hernias (3). Incisional hernias occur in 20% of patients

within 10 years after abdominal surgery (4). About 80% of these patients with incisional hernias

require surgical repair(5).

Patients with hernias of the abdominal wall seek medical care for various reasons, discomfort

being the most important (6-8). Also, patients have notice a lump in the groin, umbilicus

or at a scar after abdominal surgery. Surgical repair is advised depending on the size of the

hernia, age, co-morbidities, the living proximity to a medical centre and personal preference

of the patient. The compelling reason for surgery in these asymptomatic patients is prevention

of incarceration of visceral contents in the hernia. Particularly in the elderly, a conservative

approach, coined watchful waiting, is evaluated considering that the risk of incarceration

is low: less than 1% in patients with asymptomatic groin hernias (9-11). For umbilical and

incisional hernias this risk is still to be determined. A small group of patients with hernias of the

abdominal wall presents with tenderness of pain. These patients are usually managed surgically.

Surgery of abdominal wall hernias has been hampered for almost a century by high recurrence

rates. These recurrences have overshadowed other important aspects of surgery for hernias such

as chronic pain and loss of compliance of the abdominal wall.

The introduction of ‘tension-free’ repairs, employing meshes, by Lichtenstein in the 1970’s has

changed the surgical approach to hernias greatly and lowered recurrence rates significantly (12-

14). Traditionally, tension repairs of inguinal hernias were associated with recurrence rates as

high as 25 %. These rates decreased to less than 5 % upon use of mesh (15-18). Chronic pain

after inguinal hernia repair was rarely reported in the past but occurs frequently in up to 20 %

of all patients within the first year after surgery subsiding to less than 5 % at 5 years (4;19-21).

Management of pain in these patients has proven very complex.

Umbilical hernias are still repaired preferentially without mesh which is, however, associated with

high recurrence rates of up to 40% (22). The value of mesh in umbilical hernia surgery is currently

under review.

Incisional hernias, which occur in 15 to 20 % of patients after traditional open surgery, form

a distinct entity of abdominal wall hernias (23). Patients with incisional hernias present with a

swelling at the site of previous surgery. Pain is relatively rare in these patients. Incisional hernias

over 3 centimetres in diameter require repair with mesh. Although the use of mesh has reduced

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72 | Chapter 6

the rate of recurrences, patients continue to experience recurrent hernias in 10 to 15 % after

repair with mesh (2;9;12;23). Initially, heavy weight meshes such as small pore polypropylene

were utilized. These meshes are rigid and affect the compliance of the abdominal wall. In addition,

bowels tend to adhere to polypropylene meshes resulting in adhesive bowel obstruction and, in

rare instances, fistulas to the gut.

Introduction of mesh in surgery for hernias of the abdominal wall has shifted the focus from

recurrent hernias to quality of life. While the rate of recurrence can be determined accurately,

measuring quality of life is more demanding. Various generic tools such as Short Form-36 (SF-36)

exist but have proven not very valuable to quantify outcomes of hernia surgery (24-26).

To measure the influence of a specific surgical intervention, there is a need for disease specific

instruments with a focus on particular health outcomes. The Carolinas Comfort Scale has been

developed to evaluate the sensation of the mesh, pain and movement limitations after hernia

surgery with mesh in different aspects of daily life (6). Experience with this tool, which is currently

only available in English, is limited (6;27;28). The objective of this study is to translate and validate

the Carolinas Comfort Scale in Dutch and to assess the value of the Dutch version of the Carolinas

Comfort Scale compared to the SF-36 in a group of patients with hernias of the abdominal wall.

Material and Methods

The Medical Centre Alkmaar local ethics board approved of this study. Patients who had

undergone surgical abdominal hernia repair with a mesh between April 2010 and December

2011 at the Medical Centre Alkmaar participated in this study after gaining informed consent.

Inclusion criteria were surgical repair of inguinal, femoral, incisional or umbilical hernias with a

mesh within previous six months, being 18 years of age or older and able to read and understand

the Dutch language. Exclusion criteria were a life expectancy of less than 24 months and immune

suppression therapy within two weeks before surgery.

The English version of the Carolinas Comfort Scale was translated into Dutch (Appendix). The

translation was produced by a forward-backward procedure.

While patients were admitted in the hospital, they were asked by the study coordinator to

participate in the study. All patients were asked to complete the SF-36 and the Carolinas Comfort

Scale at home, without the presence of an interviewer, 4-7 days after surgery. A self addressed

stamped envelope was added to return completed forms. In this study we assess construct validity

by comparing the Carolinas Comfort Scale to a well-known validated quality of life questionnaire,

the SF-36. Construct validity refers to whether the new test actually measures the theoretical



6

construct that it purports to measure. Subsequently, all patients were asked to complete the

Carolinas Comfort Scale again three weeks after completing the first survey to determine test-

retest reliability. The test was mailed to the home address, including the self addressed and

stamped envelope, so all patients could complete the test at home without an interviewer present.

Questionnaires The SF-36 is a multi-purpose short form health survey containing 36 questions

about 8 domains of quality of life: physical functioning, role-physical, bodily pain, general health,

vitality, social functioning, role-emotional and mental health. These domains are scored on a scale

of 0-100, with the maximal score representing optimal functioning (24).

The Carolinas Comfort Scale (table 1) is a 23 item questionnaire that measures severity of pain,

sensation and movement limitations from the mesh in eight different categories of normal daily

life: lying down, bending over, sitting up, activities of daily living, coughing or taking a deep

breath, walking, climbing the stairs and physical or sport exercise. The score is based on a scale

0-115 with 0 being the best possible level of functioning (6).

Four questions were added to compare the Carolinas Comfort Scale and the SF-36;

1. Which questionnaire did you like best?

1. Which questionnaire is easier to understand?

2. Which questionnaire is more reflective of the problems you have with your mesh?

3. Given the choice, which questionnaire would you prefer?

Statistical analyses

To determine the construct validity of the test, the total score of the Carolinas Comfort Scale was

compared to all domains of the SF-36 using Spearman’s rank correlation coefficient test.

Cronbach’s α was used to measure reliability, or internal consistency, of the test score. This test is

commonly used to determine overall correlation between items in a scale. An outcome of 0.7 or

more is considered acceptable. In addition, we conducted a factor analysis based on all questions

of the Carolinas Comfort Scale. Test-retest reliability was estimated by Spearman’s correlation

coefficients of two assessments completed three weeks apart from each other. A principal

component analysis was performed to study if the Carolina’s Comfort Scale is unidimensional.

All data were analyzed using SPSS version 15.0 (Chicago, SPSS Inc). The significance level was

set to 0.05.

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74 | Chapter 6

Table 1: Carolinas Comfort Scale*0 = No symptoms; 1 = Mild but not bothersome symptoms; 2 = Mild and bothersome symptoms; 3 = Moderate and/or daily symptoms; 4 = Severe symptoms; 5 = Disabling symptoms

1. While lying down, do you have Sensation on the mesh 0 1 2 3 4 5 n/aPain 0 1 2 3 4 5 n/a

2. While bending over, do you have Sensation on the mesh 0 1 2 3 4 5 n/aPain 0 1 2 3 4 5 n/aMovement limitations 0 1 2 3 4 5 n/a

3. While sitting up, do you have Sensation on the mesh 0 1 2 3 4 5 n/aPain 0 1 2 3 4 5 n/aMovement limitations 0 1 2 3 4 5 n/a

4. While performing activities of daily life, do you have

Sensation on the mesh 0 1 2 3 4 5 n/a

Pain 0 1 2 3 4 5 n/aMovement limitations 0 1 2 3 4 5 n/a

5. While coughing or deep breathing, do you have Sensation on the mesh 0 1 2 3 4 5 n/aPain 0 1 2 3 4 5 n/aMovement limitations 0 1 2 3 4 5 n/a

6. While walking, do you have Sensation on the mesh 0 1 2 3 4 5 n/aPain 0 1 2 3 4 5 n/aMovement limitations 0 1 2 3 4 5 n/a

7. While walking up the stairs, do you have Sensation on the mesh 0 1 2 3 4 5 n/aPain 0 1 2 3 4 5 n/aMovement limitations 0 1 2 3 4 5 n/a

8. While exercising, do you have Sensation on the mesh 0 1 2 3 4 5 n/aPain 0 1 2 3 4 5 n/aMovement limitations 0 1 2 3 4 5 n/a

* The Carolinas Comfort Scale was created by and is licensed from the Division of Gastrointestinal and Minimally Invasive Surgery of Carolinas Medical Center in Charlotte, North Carolina.

Results

In total, 166 patients were asked to participate in this study. One hundred patients returned

completed questionnaires, 95 males and 5 females. The response rate was 60.3%. Ninety percent

of the patients had an inguinal hernia, 6% had an incisional hernia, 3% an umbilical hernia and

1% a femoral hernia.



6

Acceptability

Of the 100 patients who returned the Carolinas Comfort Scale the first time there were no

missing items in question 1-7. In 65% of the returned forms patients scored either n/a

or there were missing items in the category ‘physical exercise and sports’ and therefore this

question was left out in the analysis. Four per cent of the SF-36 had at least one missing item.

When comparing the two questionnaires, 75% preferred the Carolinas Comfort Scale and 79%

thought the Carolinas Comfort Scale was easier to understand (table 2). Eighty-three per cent of

the patients thought the Carolinas Comfort Scale to be more specific for their situation and 79%

would rather fill out the Carolinas Comfort Scale than the SF-36.

Table 2: Outcome questionnaire comparing CCS and SF 36

CCS SF36Which questionnaire did you like best? 75% 25%Which questionnaire is easier to understand? 79% 21%Which questionnaire is more reflective of the problems you have with your mesh? 83% 17%Given the choice, which questionnaire would you rather fill out? 79% 21%

Table 3: Test-retest validity (n=92)

Domain Correlation coefficient 95% Confidence interval P valueLaying down 0.286

0.4450.071-0.5230.204-0.613

< 0.01< 0.01

Bending over 0.2880.5290.563

0.083-0.5150.300-0.6840.428-0.702

< 0.01< 0.01< 0.01

Sitting 0.3310.3720.515

0.115-0.5660.166-0.5960.322-0.641

< 0.01< 0.01< 0.01

Activities of daily living 0.4560.5310.537

0.269-0.6180.332-0.6900.365-0.688

< 0.01< 0.01< 0.01

Coughing or deep breathing 0.2470.3920.333

0.026-0.4470.159-0.5950.139-0.488

0.017 < 0.01< 0.01

Walking 0.2250.4380.481

0.037-0.4220.263-0.5750.323-0.621

0.03< 0.01< 0.01

Walking stairs 0.3730.3780.417

0.149-0.5460.164-0.5440.211-0.641

< 0.01< 0.01< 0.01

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76 | Chapter 6

Reliability

The Carolinas Comfort Scale showed an excellent internal consistency, with a Cronbach’s α

coefficient of 0.948 (>0.7). The Cronbach’s coefficients ranged from 0.944-0.951 when a variable

was deleted.

Test- retest reliability

Ninety-two patients (92 %) completed the second Carolinas Comfort Scale three weeks after

surgery. Spearman’s correlation coefficient showed a correlation of 0.53 (ci 0.387-0.669, p <

0.01) for the total score of the Carolinas Comfort Scale in the test- retest validation (figure 1).

The correlation coefficients for the separate questions between the two different administrations

ranged from 0.247-0.563. This correlation was significant in all questions (table 4).

Figure 1: test-retest reliability. Total scores of the initial survey (CCS1) compared to the total score of the second survey (CCS2). This figure shows a trend towards recovery three weeks after surgery; most dots are located below the line of optimal agreement.



6

Construct validity

The validity of the Carolinas Comfort Scale was determined by comparing the scores of the

Carolinas Comfort Scale and the different domain scores of the SF-36. Spearman’s rank showed

a correlation between the different domains of the SF-36 and the Carolinas Comfort Scale

ranging from -0.006 to -0.479 (table 4). The best correlations were found in the domains physical

functioning and bodily pain (-0.479 and -0.437 respectively). In the domains role physical, vitality

and social functioning the correlation with the Carolinas Comfort Scale was also significant. Only

the domains general health, role emotional and mental health showed no significant correlations.

Table 4: Correlations between CCS and different domains of SF 36

Category Correlation 95% confidence interval p ValuePhysical Functioning -0.479 -0.658- -0.305 0.000*Role-Physical functioning -0.259 -0.450- -0.019 0.01*Bodily Pain -0.437 -0.596- -0.222 0.00*General Health -0.054 -0.283- 0.124 0.592Vitality -0.201 -0.406- 0.002 0.046*Social Functioning -0.275 -0.468- -0.041 0.006*Role Emotional -0.066 -0.255- 0.168 0.519Mental Health -0.102 -0.319- 0.104 0.316

* significant correlation

Principal component analysis

The principal component analysis determined three components, with the first component

explaining 52% of the variance (question 1a; sensation of the mesh while lying down). After

deleting this item the Crohnbach’s alpha was 0.951. All factor loadings for this first component

were > 0.3 for the unrotated solution.

Discussion

To validate the Carolina’s Comfort Scale in Dutch we compared our results to the results of

Heniford et al (6). The Carolinas Comfort Scale appears to be a valid and specific instrument

to measure quality of life after hernia surgery. The unique and additive value of the Carolinas

Comfort Scale is its focus on pain, presence of mesh sensation and limitations of movements

during walking, laying down, bending over and straining. In contrast, the SF-36 is a generic tool

to determine quality of life assessing more general variables such as bodily pain, mental health,

social and role functioning. Bodily pain does not specifically reflect pain related to surgical repair

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78 | Chapter 6

of a hernia. The impact of hernia surgery on mental health, role functioning and social functioning

seems limited rendering the SF-36 less suitable to assess outcome in patients after hernia surgery

(24-26). This is confirmed by the lack of correlation between the Carolinas Comfort Scale scores

and the domains general health, role-emotional and mental health which is fairly similar to the

findings of Heniford et al (6).

The use of simple and unequivocal questions is essential in questionnaires to generate consistent

and reliable findings that are reproducible. This is quantified by ‘test-retest reliability’. Ideally,

tests and retests are studied in patients with unchanged health conditions. In this study we

found a moderate ‘test-retest reliability’ of 0.53, whereas a reliability of 0.7 is desired (29). We

noted lower scores, reflecting less discomfort or fewer restrictions, during the retest, which was

done three weeks after the first test (figure 1). This is in accordance with expectations regarding

recovery time after hernia surgery. In our study, the period of three weeks between the test and

the retest appears too long because the condition of the patient at three weeks after surgery

was improved compared with the condition at the time of the first test. However, we believe

that if the period between the questionnaires is shorter, patients can remember their previous

answers. Heniford et al. used an interval between the two questionnaires of 6 months. It should

be stressed that our test-retest reliability is within the range reported by Heniford et al (6) and this

outcome is important in the comparison of the English and Dutch survey.

Questions left unanswered in questionnaires are another indicator of quality. In this study,

four percent of the returned SF-36 questionnaires had one or more missing answers while all

Carolinas Comfort Scale questionnaires were complete except for physical exercise. This question

was deemed inappropriate considering that patients had been instructed not to initiate physical

exercise during the first six weeks after surgery.

All items of a questionnaire, which is designed to measure in the same general construct, should

produce similar scores. This is called the internal consistency of a test. The Carolinas Comfort

Scale shows an excellent internal consistency, comparable to the original paper (6). Deleting

question 1a of the Carolinas Comfort Scale can even increase this high outcome. However, we

are very satisfied with an internal consistency of 0.944 and we prefer to use a questionnaire

comparable to the English version over a slightly improved internal consistency. Over three

quarters of all patients preferred the Carolinas Comfort Scale in comparison to the SF-36 (table

2). This is another indication of its feasibility.

A possible limitation of this study was a preponderance of patients with inguinal hernias. However,

the Carolinas Comfort Scale was designed for surgical abdominal wall hernia repair with mesh in

general and evidence exists of successful employment of the questionnaire in patients with both

inguinal as with incisional hernias (27;28).



6

In conclusion, the Carolinas Comfort Scale seems a short, feasible and effective questionnaire

to measure quality of life after surgical repair of abdominal wall hernias with mesh in a Dutch

population, compared to the English version. Adoption of this disease specific questionnaire by

more countries will facilitate international studies and evaluation of quality of life outcomes of

hernia surgery.

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80 | Chapter 6

References

1. Primatesta P, Goldacre MJ (1996) Inguinal hernia repair: incidence of elective and emergency surgery, readmission and mortality. Int J Epidemiol 25:835-839

2. Kingsnorth A, LeBlanc K (2003) Hernias: inguinal and incisional. Lancet 362:1561-1571

3. Muschaweck U (2003) Umbilical and epigastric hernia repair. Surg Clin North Am 83:1207-1221

4. den Hartog D, Dur AHM, Tuinebreijer WE, Kreis RW (2008) Open surgical procedures for incisional hernias. Cochrane Database Syst RevCD006438

5. Nieuwenhuizen J, Kleinrensink GJ, Hop WCJ, Jeekel J, Lange JF (2008) Indications for incisional hernia repair: an international questionnaire among hernia surgeons. Hernia 12:223-225

6. Heniford BT, Walters AL, Lincourt AE, Novitsky YW, Hope WW, Kercher KW (2008) Comparison of generic versus specific quality-of-life scales for mesh hernia repairs. J Am Coll Surg 206:638-644

7. Urbach DR (2005) Measuring quality of life after surgery. Surg Innov 12:161-165

8. Wright JG (1999) Outcomes research: what to measure. World J Surg 23:1224-1226

9. Fitzgibbons RJJ, Giobbie-Hurder A, Gibbs JO, Dunlop DD, Reda DJ, McCarthy MJ, Neumayer LA, Barkun JST, Hoehn JL, Murphy JT, Sarosi GAJ, Syme WC, Thompson JS, Wang J, Jonasson O (2006) Watchful waiting vs repair of inguinal hernia in minimally symptomatic men: a randomized clinical trial. JAMA 295:285-292

10. Thompson JS, Gibbs JO, Reda DJ, McCarthy MJ, Wei Y, Giobbie-Hurder A, Fitzgibbons RJJ (2008) Does delaying repair of an asymptomatic hernia have a penalty? Am J Surg 195:89-93

11. van den Heuvel B, Dwars BJ, Klassen DR, Bonjer HJ (2011) Is surgical repair of an asymptomatic groin hernia appropriate? A review. Hernia 15:251-259

12. Burger JWA, Luijendijk RW, Hop WCJ, Halm JA, Verdaasdonk EGG, Jeekel J (2004) Long-term follow-up of a randomized controlled trial of suture versus mesh repair of incisional hernia. Ann Surg 240:578-583

13. Heniford BT, Park A, Ramshaw BJ, Voeller G (2003) Laparoscopic repair of ventral hernias: nine years’ experience with 850 consecutive hernias. Ann Surg 238:391-399

14. EU Hernia Trialists Collaboration. (2000) Mesh compared with non-mesh methods of open groin hernia repair: systematic review of randomized controlled trials. Br J Surg 87:854-859

15. Eklund A, Rudberg C, Leijonmarck CE, Rasmussen I, Spangen L, Wickbom G, Wingren U, Montgomery A (2007) Recurrent inguinal hernia: randomized multicenter trial comparing laparoscopic and Lichtenstein repair. Surg Endosc 21:634-640

16. Fleming WR, Elliott TB, Jones RM, Hardy KJ (2001) Randomized clinical trial comparing totally extraperitoneal inguinal hernia repair with the Shouldice technique. Br J Surg 88:1183-1188

17. Langeveld HR, van’t Riet M, Weidema WF, Stassen LPS, Steyerberg EW, Lange J, Bonjer HJ, Jeekel J (2010) Total extraperitoneal inguinal hernia repair compared with Lichtenstein (the LEVEL-Trial): a randomized controlled trial. Ann Surg 251:819-824

18. Schmedt CG, Sauerland S, Bittner R (2005) Comparison of endoscopic procedures vs Lichtenstein and other open mesh techniques for inguinal hernia repair: a meta-analysis of randomized controlled trials. Surg Endosc 19:188-199

19. Bittner R, Arregui ME, Bisgaard T, Dudai M, Ferzli GS, Fitzgibbons RJ, Fortelny RH, Klinge U, Kockerling F, Kuhry E, Kukleta J, Lomanto D, Misra MC, Montgomery A, Morales-Conde S, Reinpold W, Rosenberg J, Sauerland S, Schug-Pass C, Singh K, Timoney M, Weyhe D, Chowbey P (2011) Guidelines for laparoscopic (TAPP) and endoscopic (TEP) treatment of inguinal hernia [International Endohernia Society (IEHS)]. Surg Endosc 25:2773-2843

20. Burger JWA, Lange JF, Halm JA, Kleinrensink GJ, Jeekel H (2005) Incisional hernia: early complication of abdominal surgery. World J Surg 29:1608-1613



6

21. Simons MP, Aufenacker T, Bay-Nielsen M, Bouillot JL, Campanelli G, Conze J, de Lange D, Fortelny R, Heikkinen T, Kingsnorth A, Kukleta J, Morales-Conde S, Nordin P, Schumpelick V, Smedberg S, Smietanski M, Weber G, Miserez M (2009) European Hernia Society guidelines on the treatment of inguinal hernia in adult patients. Hernia 13:343-403

22. Aslani N, Brown CJ (2010) Does mesh offer an advantage over tissue in the open repair of umbilical hernias? A systematic review and meta-analysis. Hernia 14:455-462

23. Sajid MS, Bokhari SA, Mallick AS, Cheek E, Baig MK (2009) Laparoscopic versus open repair of incisional/ventral hernia: a meta-analysis. Am J Surg 197:64-72

24. Brazier JE, Harper R, Jones NM, O’Cathain A, Thomas KJ, Usherwood T, Westlake L (1992) Validating the SF-36 health survey questionnaire: new outcome measure for primary care. BMJ 305:160-164

25. Patrick DL, Deyo RA (1989) Generic and disease-specific measures in assessing health status and quality of life. Med Care 27:S217-S232

26. Burney RE, Jones KR, Coon JW, Blewitt DK, Herm A, Peterson M (1997) Core outcomes measures for inguinal hernia repair. J Am Coll Surg 185:509-515

27. Belyansky I, Tsirline VB, Klima DA, Walters AL, Lincourt AE, Heniford TB (2011) Prospective, comparative study of postoperative quality of life in TEP, TAPP, and modified Lichtenstein repairs. Ann Surg 254:709-714

28. Hope WW, Lincourt AE, Newcomb WL, Schmelzer TM, Kercher KW, Heniford BT (2008) Comparing quality-of-life outcomes in symptomatic patients undergoing laparoscopic or open ventral hernia repair. J Laparoendosc Adv Surg Tech A 18:567-571

29. BB Gerstman (2008) Basic Biostatistics: Statistics for Public Health Practice. Jones and Bartlett Publishers. Sudbury, Canada,

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82 | Chapter 6

Appendix

CarolinasComfortScale™

Dit is een vragenlijst over uw kwaliteit van leven.

Beantwoord alstublieft ALLE vragen voor elk van de 8 activiteiten. Gebruik nvt (niet van toepassing)

als u een activiteit niet verricht. Omcirkel het juiste antwoord. (0= niet, 5= heel erg)

1. Als u gaat liggen, voelt u dan

a.) de mat zitten 0 1 2 3 4 5 nvt

b.) Pijn 0 1 2 3 4 5 nvt

2. Wanneer u bukt, voelt u dan:


b.) Pijn 0 1 2 3 4 5 nvt

c.) een bewegingsbeperking 0 1 2 3 4 5 nvt

3. Wanneer u gaat zitten, voelt u dan:


b.) pijn 0 1 2 3 4 5 nvt


4. In uw dagelijks leven (bijvoorbeeld bij het uit bed stappen, douchen, aankleden) voelt u dan:


b.) pijn 0 1 2 3 4 5 nvt




6

5. Wanneer u hoest of diep adem haalt, voelt u dan:


b.) pijn 0 1 2 3 4 5 nvt


6. Wanneer u loopt of staat, voelt u dan:


b.) pijn 0 1 2 3 4 5 nvt


7. Wanneer u de trap op of af loopt, voelt u dan:


b.) pijn 0 1 2 3 4 5 nvt


8. Wanneer u sport (anders dan werkgerelateerd), voelt u dan:


b.) pijn 0 1 2 3 4 5 nvt


Chapter 7

Laparoscopic incisional hernia repair:

Influence of surgical technique on recurrence rate

A systematic review of the literature

M.M. Poelman

J.D. Deelder

E. de Lange

W.H. Schreurs

H.J. Bonjer

Submitted

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86 | Chapter 7

Abstract

Introduction Recent studies reported that laparoscopic incisional hernia repair is at least as

effective as the open approach. The technique of laparoscopic incisional hernia repair has not

been standardized.

Methods A systematic review of the literature was performed to evaluate the surgical technique

of laparoscopic incisional hernia repair with outcomes. PubMed was searched using the

following key words; incisional hernia, ventral hernia, mesh, fixation, laparoscopy, endoscopy

and combinations of these words. Relevant articles published prior to August 2012 were selected.

Methodological Index of Nonrandomized Studies (MINORS) criteria were adapted for this topic.

Two independent researchers appraised all the publications with the use of these modified

MINORS criteria to assess their methodology. Primary outcome was recurrence rate.

A meta-analysis was performed for the influence of three factors (number of transfascial sutures,

type of mesh and overlap of the mesh) on recurrence rates. Forest plots were used as a graphical

design to display the relative strength of each individual study.

Results Twenty-one articles, with a total number of 2353 patients were selected for evaluation.

Indications for repair were unclear in almost all studies. Mesh was employed in all studies. The

conversion rate to an open procedure was 2.8%. Relaparotomies were performed in 2.7% of all

patients in less than a week after index surgery. Recurrences were determined based on physical

examinations, the reported recurrence rate was 5,2%.

Analysis of the subgroups (overlap of < 3cm vs overlap of >5cm/use of ≥4 TFS vs use of ≤2 TFS/

Dual mesh vs Parietex mesh) did not show any significant difference in recurrence rates.

Discussion In spite of numerous reports on laparoscopic incisional hernia repair, a preferred

surgical technique has not yet been determined.


Laparoscopic incisional hernia repair: Influence of surgical technique on recurrence rate | 87

7

Introduction

Incisional hernias are defects of the fascia of the abdominal wall, covered by skin, which develop

after open abdominal surgery. Bulging of abdominal contents through the scar occurs when

patients are standing up or coughing. Incisional hernias may be asymptomatic, but are frequently

associated with pain or discomfort affecting quality of life and economic productivity. Entrapment

of bowel jeopardizing the blood supply, strangulation, is the most concerning consequence of

incisional hernias. Incisional hernias do affect the quality of life and economic productivity of

patients (1,2). Obesity, wound infections and collagen disorders are risk factors for developing

incisional hernias (3,4).

Currently, eighty percent of all patients with an incisional hernia undergo surgical repair (5) in

the Western world. Clear criteria to determine whether either surgical repair or conservative

approach is preferable have not yet been determined. A wide variety of surgical techniques, both

open and laparoscopic, to repair incisional hernias exist.

Infection of surgical incisions, skin necrosis, seroma and infection of the prosthetic material

are potential complications of incisional hernia surgery. Extensive mobilization of the skin and

subcutaneous tissue endangering the blood supply and exposure of prosthetic material to large

incisions predispose to impaired wound healing and subsequent infection. Laparoscopic surgery

could improve outcomes of incisional hernia repair because it employs small incisions and it

avoids a blunt traumatic dissection. Less pain, shorter hospital stay and fewer complications after

laparoscopic incisional hernia repair have been reported. Two recent meta-analyses (6,7) that

included 366 and 526 patients (overlapping studies were included in these two analyses) reported

that laparoscopic repair was at least as effective and possibly superior to the open approach in

terms of hospital stay and post-operative complications. The technique of laparoscopic incisional

hernia repair has not been standardized.

A review of the literature was performed to evaluate the surgical technique of laparoscopic

incisional hernia repair with outcomes, to define the optimal technique.

Methods

Search strategy

For this review PubMed was searched and relevant articles were identified published prior to

August 2012, using the following key words; incisional hernia, ventral hernia, mesh, fixation,

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88 | Chapter 7

laparoscopy, endoscopy and combinations of these words. A flowchart of the search strategy is

shown in figure 1. Furthermore, reference lists of these articles were cross-searched for additional

literature. There was no data limit set, and only papers written in English were included. Papers

that did not describe laparoscopic incisional hernia repair, but also ventral hernia repair and that

did not differentiate between these two groups were excluded. In case of overlapping studies, the

study with the longest study-period was chosen.

76

Methods

Search strategy For this review PubMed was searched and relevant articles were identified

published prior to August 2012, using the following key words; incisional hernia, ventral hernia,

mesh, fixation, laparoscopy, endoscopy and combinations of these words. A flowchart of the

search strategy is shown in figure 1. Furthermore, reference lists of these articles were cross-

searched for additional literature. There was no data limit set, and only papers written in English

were included. Papers that did not describe laparoscopic incisional hernia repair, but also

ventral hernia repair and that did not differentiate between these two groups were excluded. In

case of overlapping studies, the study with the longest study-period was chosen.

Figure 1: flowchart of the search strategy

MINORS criteria Methodological Index of Nonrandomized Studies, also known as the ‘MINORS’

criteria, [8] was developed as a tool to assess the methodology of observational studies such as

case-control and cohort designs. Although an increasing number of randomized controlled trials

are conducted, most available evidence in surgery comes from non-randomized studies.

However, a systematic review or meta-analysis of the combined results of observational studies

of varying quality could be highly biased. The MINORS criteria were developed to perform a

quality assessment of observational studies before conducting a systematic review with these

studies. It is a validated tool [8]. The MINORS criteria can be adapted to specific topics of the

research. In this study the modification entailed specification to studies that describe the

Figure 1: flowchart of the search strategy

MINORS criteria

Methodological Index of Nonrandomized Studies, also known as the ‘MINORS’ criteria, (8) was

developed as a tool to assess the methodology of observational studies such as case-control and

cohort designs. Although an increasing number of randomized controlled trials are conducted,

most available evidence in surgery comes from non-randomized studies. However, a systematic

review or meta-analysis of the combined results of observational studies of varying quality

could be highly biased. The MINORS criteria were developed to perform a quality assessment of

observational studies before conducting a systematic review with these studies. It is a validated

tool (8). The MINORS criteria can be adapted to specific topics of the research. In this study

the modification entailed specification to studies that describe the technique of laparoscopic

incisional hernia repair (modified MINORS, table 1). These modified MINORS criteria were used to

assess the quality of the observational studies.



7

Table 1: Modified MINORS

0 1 21. Clearly stated aim No aim described Partially described (i.e.

evaluation of a case serie)Clearly stated aim

2. Number of included patients

<20 >20

3. Inclusion of consecutive patients

Was not described Only a time frame (i.e. from 1997 until 2000)

Consecutive patients + patient characteristics.

4. Type of hernia specified Unspecified Only ‘incisional hernia’ specified

Specification of the location and size of the hernia

5. Surgical technique Was not reported Reported incomplete (i.e. type of mesh was not specified)

Completely specified, including type of mesh, type of fixation and cm overlap.

6. Report of end points Was not reported Only some endpoints reported (i.e. recurrences)

All complications reported.

Critical appraisal

Two independent researchers (MMP and JDD) appraised all the publications and scored them

using the modified MINORS. In case of disagreement, a senior researcher (WHS) was asked for

help and made the final decision whether to in- or exclude the study. Publications with a score of

less than 9 were excluded, as well as publications that scored ‘zero’ on any item of the modified

MINORS. Studies that did not describe the full surgical technique including type of mesh, overlap

of the mesh of the fascia and type of fixation (i.e. minimum of 2 point on MINORS point 5) were

also excluded. Overlapping cohorts were identified and the study with the longest study period

was included. Only studies with a median follow-up of at least 12 months were included in the

analysis.

Primary and Secondary Outcome

The primary outcome was recurrence of the incisional hernia. Secondary outcomes were wound-

and mesh infection and pain.

Data Extraction

All reports were thoroughly reviewed, and data for primary and secondary outcomes were

extracted. Study design, year of publication, number of included and evaluated patients, surgical

technique (choice of mesh, choice and number of transfascial sutures, choice of tackers and

centimeters of overlap), morbidity, re-interventions and duration of follow-up were listed.

Three subgroups were formed for differences in surgical technique: choice of mesh, number of

transfascial sutures used and amount of overlap of the mesh over the fascia.

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90 | Chapter 7

Analysis A meta-analysis (applying the random effects method of DerSimonian-Laird) was

performed for each of these subgroups to see if any combination of variables would show a

certain trend in influence on recurrence rate. Forest plots were used as a graphical design to

display the relative strength of each individual study. A line represents each study; the width of

the line shows the 95%- confidence interval of the effect estimate of the individual studies. The

area of the box represents the weight given to a study. The diamond below the studies represents

the overall effect; the width of the diamond shows the confidence intervals of the overall effect

estimate.

Results

Twenty-one articles, with a total number of 2353 patients were selected for evaluation (9-29)

(Table 2). Three randomized controlled trials on laparoscopic surgical technique were found (30-

32) but excluded for analysis. Reasons for exclusion were inclusion of both primary ventral and

incisional hernias and lack of follow up.

Indications for repair were unclear in all studies, except for one study (23) on incarcerated incisional

hernias. Mesh was employed in all studies and all but one study reported to use tacker fixation

of the mesh, with or without transfascial sutures. The conversion rate to an open procedure was

2.8%. Re-interventions were performed because of suspected bowel injury, trocar site hernia,

intra-abdominal bleeding, mesh infection and extreme pain. Relaparotomies were performed in

2.7% of all patients in less than a week after index surgery. Removal of mesh at relaparotomy for

bowel perforation was not reported as a recurrence.

Follow-up studies were done mostly in clinic and included physical examination. Hence recurrences

were determined based on physical examinations. Only 2 studies reported use of CT scan or

ultrasonography to confirm recurrences, while in other studies the presence of a recurrent hernia

at reoperation was considered evidence of a recurrence. Overall, there was a reported recurrence

rate of 5.2% in this analysis.

Only 10 authors reported on post-operative chronic pain. Validated pain-scores were seldom

used. Three mortalities were reported due to cardio-pulmonary events. Trocar site hernias were

only recorded in 6 out of 1115 patients (0.5 %).



7

Table 2

study n= M type of mesh TFS overlap FU C R SSI MI re-lap BI M TSH P

Bageacu / 2002 (9) 159 12 various variable 5cm 49 21 19 3 0 3 10 0 U 31

Bencini/ 2003 (10) 42 11 Dual Mesh 4 3-4cm 17 0 0 0 0 0 2 0 U U

Berger/ 2002 (11) 150 10 Dual Mesh >4 3-5 cm 12 1 4 0 1 4 4 1 4 U

Berger/ 2009 (12) 297 10 Dynamesh >4 5cm 24 1 2 2 1 5 1 1 1 6

Carbajo/ 2003 (13) 270 9 Dual Mesh 0 5cm 44 1 12 0 U 2 9 0 U 20

Cecceralli/ 2008 (14) 94 10 Composix 4 3-5cm 38 0 2 0 0 0 0 U U 0

Heniford/ 2000 (15) 100 9 ePTFE >4 3-4cm 22.5 0 1 0 1 2 1 U U U

Kirshtein/ 2002 (16) 103 10 Dual Mesh 4 3cm 26 3 4 3 2 0 2 0 0 U

Koehler/ 1999 (17) 32 11 Dual Mesh >6 5cm 20 U 3 2 1 2 2 1 U U

Kurmann / 2011 (18) 69 12 Dual-layered >4 5cm 33 7 11 4 U 17 U 0 U 13

Liang / 2012 (19) 22 11 Coated polyester >4 6cm 21 U 0 0 0 5 U 0 0 U

Moreno Egea/ 2010 (20) 200 11 Parietex 4 5cm 60 5 11 1 0 0 5 0 0 0

Motson/ 2006 (21) 117 10 Prolene 0 3cm 42 5 9 0 3 4 6 U U U

Olmi / 2006 (22) 156 10 Parietex 0 4-5cm 29 0 4 U 1 U 7 0 0 3

Olmi / 2009 (23) 48 9 Parietex 0 4-5cm 38 0 0 U 0 0 2 0 0 U

Riet van ‘t/ 2002 (24) 25 10 Polypropylene variable 3cm 17 3 4 1 0 0 2 U U U

Stickel / 2007 (25) 62 9 Dual Mesh 4 5cm 13 1 3 1 1 1 1 0 U 19

Sturt/ 2011 (26) 227 11 Various <2 3cm 17 8 25 5 3 7 0 U U 8

Verbo et al/ 2007 (27) 41 9 Dual Mesh 0 3-4cm 38 0 1 0 0 1 1 0 0 U

Wolter / 2009 (28) 41 9 Various 4 3cm 23 2 3 1 1 2 1 0 U 4

Yannam/ 2011 (29) 98 11 Various >4 3cm 32 9 9 1 4 8 2 0 1 U

2353 127

U= unknown/ M= minors score/ TFS= Transfascial sutures/ FU= median follow-up in months/ C= conversion to open procedureR= recurrence/ SSI= surgical site infection/ MI= mesh infectionBI= bowel injury/ M= mortality/ TSH= trocar site hernia/ P= pain

Correlation of the surgical technique and recurrence rate

Overlap of mesh

The degree of overlap of the mesh relative to the fascial margin was reported in all but one

article. An analysis was done to determine recurrence rates associated with overlap of less than 3

centimeters and overlap greater than 5 centimeters (table 3 and figure 2). The forest plot (figure

2) shows the number of recurrences (from zero to a hundred percent) for each study and their

95%-confidence interval. The weight of the study is represented by the size of the box. When

more than 5cm overlap was used, the overall recurrence rate was 6%. When 3cm or less overlap

was used, the overall recurrence rate was 9.1%. This was not a significant difference.

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92 | Chapter 7

Table 3: Included studies for overlap of the mesh over the fascia.

study n= overlap median FU RKirshtein/ 2002 103 ≤3cm 26 months 4Motson/ 2006 117 ≤3cm 42 monhts 9Riet van ‘t/ 2002 25 ≤3cm 17 months 4Sturt/ 2011 227 ≤3cm 17 months 25Wolter/ 2009 41 ≤3cm 23 months 3Yannam/ 2011 98 ≤3cm 32 months 9

total 611Bageacu/ 2002 159 ≥5cm 49 months 19Berger/ 2009 297 ≥5cm 24 months 2Carbajo/ 2003 270 ≥5cm 44 months 12Koehler/ 1999 32 ≥5cm 20 months 3Kurmann/ 2011 69 ≥5cm 33 months 11Liang / 2012 22 ≥5cm 21 months 0Moreno Egea/ 2010 200 ≥5cm 60 months 11Stickel/ 2007 62 ≥5cm 13 months 3

total 1111R=recurrence

FU= follow up/ R= number of recurrences.

81

Figure 2: Forest plot for overlap of the mesh over the fascia

Number of transfascial sutures. The number of transfascial sutures (TFS) used in each group was

listed. Two studies were excluded from the analysis because they reported to use TFS in ‘6 out

of 25’ patients and one group reported to use either 1 or 4 TFS. Twenty-two studies were used

in the analysis (table 4 and figure 3). In the subgroup of studies, where ≥4 TFS were used, the

overall recurrence rate was 4.5%. In the subgroup where ≤2 TFS were used the overall

recurrence rate was 5.3%. No clear trend could be noticed. As pain was not reported in most of

the studies, it was not possible to investigate the relationship between the number of TFS and

pain.

Figure 2: Forest plot for overlap of the mesh over the fascia



7

Number of transfascial sutures

The number of transfascial sutures (TFS) used in each group was listed. Two studies were excluded

from the analysis because they reported to use TFS in ‘6 out of 25’ patients and one group

reported to use either 1 or 4 TFS. Twenty-two studies were used in the analysis (table 4 and figure

3). In the subgroup of studies, where ≥4 TFS were used, the overall recurrence rate was 4.5%. In

the subgroup where ≤2 TFS were used the overall recurrence rate was 5.3%. No clear trend could

be noticed. As pain was not reported in most of the studies, it was not possible to investigate the

relationship between the number of TFS and pain.

Table 4: included studies in analysis for transfascial sutures (TFS).

study n= TFS median FU RBencini/ 2003 42 ≥4 17 months 0Berger/ 2002 150 ≥4 12 months 4Berger/ 2009 297 ≥4 24 months 2Cecceralli/ 2008 94 ≥4 38 months 2Heniford/ 2000 100 ≥4 22.5 months 1Kirshtein/ 2002 103 ≥4 26 months 4Koehler/ 1999 32 ≥4 20 months 3Kurmann/ 2011 69 ≥4 33 months 11Liang/ 2012 22 ≥4 21 months 0Moreno Egea/ 2010 200 ≥4 60 months 11Stickel/ 2007 62 ≥4 13 months 3Wolter/ 2009 41 ≥4 23 months 3Yannam/ 2011 98 ≥4 32 months 9

total: 1310Carbajo/ 2003 270 ≤2 44 months 12Motson/ 2006 117 ≤2 42 monhts 9Olmi/ 2006 156 ≤2 29 months 4Olmi/ 2009 48 ≤2 38 months 0Sturt/ 2011 227 ≤2 17 months 25Verbo/ 2007 41 ≤2 38 months 1

total: 859R= recurrence

FU= follow up/ R= number of recurrences

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94 | Chapter 7

82

Table 4: included studies in analysis for transfascial sutures (TFS).

FU= follow up/ R= number of recurrences

Figure 3: Forest plot for number of transfacial sutures (TFS) used Figure 3: Forest plot for number of transfacial sutures (TFS) used

Type of mesh

In this review, Parietex composite mesh (Covidien, n=404) and Dual Mesh (Gore, n=700) were

most frequently used. The studies using one of these meshes were extracted and compared for

a difference in recurrence (table 5 and figure 4). In the Parietex group, the overall recurrence rate

was 3.8% while in the Dual mesh subgroup the overall recurrence rate was 4.2%.

In the Dual Mesh group 5 mesh infections were reported in these studies whereas 1 mesh

infection was reported in the Parietex group. This was not a significant difference.



7

Table 5: included studies in analysis for Parietex vs DualMesh

study n= mesh median FU RMoreno Egea/ 2010 200 1 60 months 11Olmi/ 2006 156 1 29 months 4Olmi/ 2009 48 1 38 months 0

total: 404Bencini/ 2003 42 2 17 months 0Berger/ 2002 150 2 12 months 4Carbajo/ 2003 270 2 44 months 12Kirshtein/ 2002 103 2 26 months 4Koehler/ 1999 32 2 20 months 3Stickel/ 2007 62 2 13 months 3Verbo/ 2007 41 2 38 months 1

total: 700Parietex=1/ Dual mesh= 2R=recurrence

Type of mesh 1= Parietex/ 2= Dual Mesh.FU= follow up/ R= number of recurrences

84

Figure 4: Forest plot for Dual mesh vs Parietex mesh

Incisional hernias of the abdominal wall occur in 15 to 20 percent after laparotomy [1].

However, only some of these patients who develop incisional hernias undergo surgery because

many of these hernias are asymptomatic. Evidence regarding the necessity to undertake a repair

of an incisional hernia is not available. It is surprising that the considerations for incisional hernia

repair were not recorded in the studies that were reviewed. Accurate documentation of the

severity and localization of pain, range of physical activity and cosmesis before and after surgery

is required to assess the benefit of incisional hernia surgery. Furthermore, more information on

the natural course of incisional hernias is needed to validate a ‘wait and see’ policy in patients

with incisional hernias.

There are a wide variety of meshes and fixation techniques available to the surgical team to

reconstruct the abdominal wall. The requirements for these meshes include compliance similar

to that of the abdominal wall of the patient, good attachment to the abdominal wall opposed to

Figure 4: Forest plot for Dual mesh vs Parietex mesh

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96 | Chapter 7

Discussion

Laparoscopic surgery is progressively employed in patients with incisional hernia because this

minimally invasive technique is considered to be associated wit short-term advantages such as

reduced pain, earlier recovery and shorter hospital stay (6,7). In spite of numerous reports on

laparoscopic incisional hernia repair, a preferred surgical technique has not yet been determined.

Long term restoration of the integrity of the abdominal wall without postoperative pain or risk of

visceral adhesions is the ultimate goal of incisional hernia repair.

Incisional hernias of the abdominal wall occur in 15 to 20 percent after laparotomy (1). However,

only some of these patients who develop incisional hernias undergo surgery because many of

these hernias are asymptomatic. Evidence regarding the necessity to undertake a repair of an

incisional hernia is not available. It is surprising that the considerations for incisional hernia repair

were not recorded in the studies that were reviewed. Accurate documentation of the severity and

localization of pain, range of physical activity and cosmesis before and after surgery is required

to assess the benefit of incisional hernia surgery. Furthermore, more information on the natural

course of incisional hernias is needed to validate a ‘wait and see’ policy in patients with incisional

hernias.

There are a wide variety of meshes and fixation techniques available to the surgical team to

reconstruct the abdominal wall. The requirements for these meshes include compliance similar

to that of the abdominal wall of the patient, good attachment to the abdominal wall opposed

to lack of adherence to the viscera, pliability allowing insertion of a large mesh through a trocar

and resistance to micro-organisms. Evidence providing guidance to surgeons and patients for

selecting the optimal mesh is not available. Employment of various meshes combined with

different fixation techniques renders such an analysis very difficult. Hence, this review of more

than 2,000 patients has not provided a better understanding of the outcomes of different meshes

and fixation techniques.

An overlap of mesh of at least 3-5 centimeters is recommended in all studies included in the

analysis. The rationale is mesh shrinkage, which appears to be influenced by the pore-size, weight

of the mesh, fixation method of the mesh and the inflammatory response of the host. This review

showed a trend towards a lower recurrence rate when the overlap of the mesh was greater than

5 centimeters.



7

Transfascial sutures are used to keep the mesh in place and position the mesh over the defect.

Transfascial sutures might cause post-operative pain due to entrapment of nerves of the

abdominal wall in the knot of the suture. Besides transfascial sutures, the mesh is often fixated to

the abdominal wall with the use of tacks or sutures.

The randomized controlled studies on the influence of surgical technique (i.e. tacker vs suture

fixation) on QOL and pain were ambiguous (30,32). The study performed by Wassenaar et al

did not find any difference in post-operative pain or QOL comparing suture (absorbable or non-

absorbable) or tacker fixation. The Bansal study showed a reduction of early post-operative

pain and return to activity in favor of suture fixation compared to tacker fixation of the mesh.

Transfascial sutures were used in both groups.

Tackers are usually non-absorbable, but are produced in absorbable material as well. Absorbable

tackers have been designed because the definitive fixation methods were thought to cause pain.

Absorbable tackers might be related with a lower tensile strength of fixation of the mesh to the

abdominal wall compared to non-absorbable tacks, the reason why the latter are more often

used. Nonetheless, this has only been proven in animal studies (36,37).

The shape and penetration depth of the fixation device probably plays a key role in tensile

strength. Non-absorbable metal tacks might cause more intra-abdominal adhesions of viscera

to the tacks than absorbable tack (36,38) at the long term. On the other hand, at follow-up

until 6 months after the index surgery, some ‘absorbable tackers’ did not show any signs of

degeneration (38). A difference in post-operative pain between definitive and resorbable fixation

has never been determined.

In conclusion, thorough registries of patients with incisional hernias who undergo surgical repair

and of those who abstain from surgery are of great importance to learn more about the outcomes

of surgical and non-surgical management of incisional hernias. Comparing standardized surgical

techniques in randomized clinical trials is another necessary method to improve the quality of care

that we provide to patients with incisional hernias.

A randomized trial is needed to know which patients are suitable for an endoscopic repair, the

natural course of an incisional hernia in asymptomatic patients, what surgical technique to

choose and the effect on morbidity such as recurrence rate and quality of life. Authors initiated

the “INCH trial”, a randomized controlled trial and registry that started July 2012, in which they

aim to find an answer on some of these questions.

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98 | Chapter 7

References

1. Cassar K, Munro A. Surgical treatment of incisional hernia. Br J Surg 2002, May;89(5):534-45.


3. Rosch R, Junge K, Knops M, Lynen P, Klinge U, Schumpelick V. Analysis of collagen-interacting proteins in patients with incisional hernias. Langenbecks Arch Surg 2003, Feb;387(11-12):427-32.

4. Llaguna OH, Avgerinos DV, Lugo JZ, Matatov T, Abbadessa B, Martz JE, Leitman IM. Incidence and risk factors for the development of incisional hernia following elective laparoscopic versus open colon resections. Am J Surg 2010, Aug;200(2):265-9.

5. Nieuwenhuizen J, Kleinrensink GJ, Hop WC, Jeekel J, Lange JF. Indications for incisional hernia repair: An international questionnaire among hernia surgeons. Hernia 2008, Jun;12(3):223-5.

6. Sajid MS, Bokhari SA, Mallick AS, Cheek E, Baig MK. Laparoscopic versus open repair of incisional/ventral hernia: A meta-analysis. Am J Surg 2009, Jan;197(1):64-72.

7. Forbes SS, Eskicioglu C, McLeod RS, Okrainec A. Meta-analysis of randomized controlled trials comparing open and laparoscopic ventral and incisional hernia repair with mesh. Br J Surg 2009, Aug;96(8):851-8.

8. Slim K, Nini E, Forestier D, Kwiatkowski F, Panis Y, Chipponi J. Methodological index for non-randomized studies (minors): Development and validation of a new instrument. ANZ J Surg 2003, Sep;73(9):712-6.

9. Bageacu S, Blanc P, Breton C, Gonzales M, Porcheron J, Chabert M, Balique JG. Laparoscopic repair of incisional hernia: A retrospective study of 159 patients. Surg Endosc 2002, Feb;16(2):345-8.

10. Bencini L, Sanchez LJ, Scatizzi M, Farsi M, Boffi B, Moretti R. Laparoscopic treatment of ventral hernias: Prospective evaluation. Surg Laparosc Endosc Percutan Tech 2003, Feb;13(1):16-9.

11. Berger D, Bientzle M. Polyvinylidene fluoride: A suitable mesh material for laparoscopic incisional and parastomal hernia repair! A prospective, observational study with 344 patients. Hernia 2009, Apr;13(2):167-72.

12. Berger D, Bientzle M, Müller A. Postoperative complications after laparoscopic incisional hernia repair. Incidence and treatment. Surg Endosc 2002, Dec;16(12):1720-3.

13. Carbajo MA, Martp del Olmo JC, Blanco JI, Toledano M, de la Cuesta C, Ferreras C, Vaquero C. Laparoscopic approach to incisional hernia. Surg Endosc 2003, Jan;17(1):118-22.

14. Ceccarelli G, Patriti A, Batoli A, Bellochi R, Spaziani A, Pisanelli MC, Casciola L. Laparoscopic incisional hernia mesh repair with the “double-crown” technique: A case-control study. J Laparoendosc Adv Surg Tech A 2008, Jun;18(3):377-82.

15. Heniford BT, Ramshaw BJ. Laparoscopic ventral hernia repair: A report of 100 consecutive cases. Surg Endosc 2000, May;14(5):419-23.

16. Kirshtein B, Lantsberg L, Avinoach E, Bayme M, Mizrahi S. Laparoscopic repair of large incisional hernias. Surg Endosc 2002, Dec;16(12):1717-9.

17. Koehler RH, Voeller G. Recurrences in laparoscopic incisional hernia repairs: A personal series and review of the literature. JSLS 1999;3(4):293-304.

18. Kurmann A, Visth E, Candinas D, Beldi G. Long-term follow-up of open and laparoscopic repair of large incisional hernias. World J Surg 2011, Feb;35(2):297-301.

19. Liang MK, Subramanian A, Awad SS. Laparoscopic transcutaneous closure of central defects in laparoscopic incisional hernia repair. Surg Laparosc Endosc Percutan Tech 2012, Apr;22(2):e66-70.

20. Moreno-Egea A, Bustos JA, Girela E, Aguayo-Albasini JL. Long-term results of laparoscopic repair of incisional hernias using an intraperitoneal composite mesh. Surg Endosc 2010, Feb;24(2):359-65.

21. Motson RW, Engledow AH, Medhurst C, Adib R, Warren SJ. Laparoscopic incisional hernia repair with a self-centring suture. Br J Surg 2006, Dec;93(12):1549-53.



7

22. Olmi S, Erba L, Magnone S, Bertolini A, Croce E. Prospective clinical study of laparoscopic treatment of incisional and ventral hernia using a composite mesh: Indications, complications and results. Hernia 2006, Jun;10(3):243-7.

23. Olmi S, Cesana G, Erba L, Croce E. Emergency laparoscopic treatment of acute incarcerated incisional hernia. Hernia 2009, Dec;13(6):605-8.

24. van’t RM, Vrijland WW, Lange JF, Hop WC, Jeekel J, Bonjer HJ. Mesh repair of incisional hernia: Comparison of laparoscopic and open repair. Eur J Surg 2002;168(12):684-9.

25. Stickel M, Rentsch M, Clevert DA, Hernandez-Richter T, Jauch KW, Löhe F, Angele MK. Laparoscopic mesh repair of incisional hernia: An alternative to the conventional open repair? Hernia 2007, Jun;11(3):217-22.

26. Sturt NJ, Liao CC, Engledow AH, Menzies D, Motson RW. Results of laparoscopic repair of primary and recurrent incisional hernias at a single UK institution. Surg Laparosc Endosc Percutan Tech 2011, Apr;21(2):86-9.

27. Verbo A, Petito L, Manno A, Coco C, Mattana C, Lurati M, et al. Laparoscopic approach to recurrent incisional hernia repair: A 3-year experience. J Laparoendosc Adv Surg Tech A 2007, Oct;17(5):591-5.

28. Wolter A, Rudroff C, Sauerland S, Heiss MM. Laparoscopic incisional hernia repair: Evaluation of effectiveness and experiences. Hernia 2009, Oct;13(5):469-74.

29. Yannam GR, Gutti TL, High R, Stevens RB, Thompson JS, Morris MC. Experience of laparoscopic incisional hernia repair in kidney and/or pancreas transplant recipients. Am J Transplant 2011, Feb;11(2):279-86.

30. Wassenaar E, Schoenmaeckers E, Raymakers J, van der Palen J, Rakic S. Mesh-fixation method and pain and quality of life after laparoscopic ventral or incisional hernia repair: A randomized trial of three fixation techniques. Surg Endosc 2010, Jun;24(6):1296-302.

31. Bansal VK, Misra MC, Babu D, Singhal P, Rao K, Sagar R, et al. Comparison of long-term outcome and quality of life after laparoscopic repair of incisional and ventral hernias with suture fixation with and without tacks: A prospective, randomized, controlled study. Surg Endosc 2012, Dec;26(12):3476-85.

32. Bansal VK, Misra MC, Kumar S, Rao YK, Singhal P, Goswami A, et al. A prospective randomized study comparing suture mesh fixation versus tacker mesh fixation for laparoscopic repair of incisional and ventral hernias. Surg Endosc 2011, May;25(5):1431-8.

33. Sauerland S, Walgenbach M, Habermalz B, Seiler CM, Miserez M. Laparoscopic versus open surgical techniques for ventral or incisional hernia repair. Cochrane Database Syst Rev 2011(3):CD007781.

34. Cobb WS, Kercher KW, Heniford BT. Laparoscopic repair of incisional hernias. Surg Clin North Am 2005, Feb;85(1):91-103, ix.

35. Shankaran V, Weber DJ, Reed RL, Luchette FA. A review of available prosthetics for ventral hernia repair. Ann Surg 2011, Jan;253(1):16-26.

36. Duffy AJ, Hogle NJ, LaPerle KM, Fowler DL. Comparison of two composite meshes using two fixation devices in a porcine laparoscopic ventral hernia repair model. Hernia 2004, Dec;8(4):358-64.

37. Hollinsky C, Kolbe T, Walter I, Joachim A, Sandberg S, Koch T, et al. Tensile strength and adhesion formation of mesh fixation systems used in laparoscopic incisional hernia repair. Surg Endosc 2010, Jun;24(6):1318-24.

38. Reynvoet E, Berrevoet F, De Somer F, Vercauteren G, Vanoverbeke I, Chiers K, Troisi R. Tensile strength testing for resorbable mesh fixation systems in laparoscopic ventral hernia repair. Surg Endosc 2012, Sep;26(9):2513-20.

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PART II

Groin hernias

Chapter 8

EAES Consensus Development Conference

on endoscopic repair of groin hernias

M.M. Poelman

B. van den Heuvel

J.D. Deelder

G.S.A. Abis

N. Beudeker

R.K.J. Bittner

G. Campanelli

D. van Dam

B.J. Dwars

H. Eker

A. Fingerhut

I. Khatov

F. Kockerling

J.F. Kukleta

M. Miserez

A. Montgomery

R.M. Munoz Brands

S. Morales Conde

F.E. Muysoms

M. Soltes

W. Tromp

Y. Yavuz

H.J. Bonjer

Surg Endosc. 2013 Oct;27(10):3505-19

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104 | Chapter 8


EAES Consensus Development Conference on endoscopic repair of groin hernias | 105

8

Introduction

Groin hernia repair is one of the most common surgeries performed globally in more than 20

million people per year. (1; 2) The first surgeries for groin hernias were done in by the end

of the 16th century. (3; 4) Repairs that involved reduction and resection of the hernial sac and

enforcement of the posterior wall of the inguinal canal by approximating its muscular and fascial

components were done by the end of the 19th century. Utilization of prosthetic material was

introduced in the 1960’s, initially only in elderly patients with recurrent inguinal hernias. Favorable

long-term results of these mesh repairs allowed adoption of mesh repair in a larger group of

patients. At the present time, the majority of surgeons prefers mesh repair of inguinal hernias.

In the early 1980’s, minimally invasive techniques for groin hernia repair were first reported,

adding another modality to the management of these hernias. (4) Transperitoneal laparoscopic

and extraperitoneal endoscopic techniques, collectively coined ‘endoscopic surgery’, have been

developed. There is considerable variation of surgical techniques in endoscopic repair of groin

hernias rendering development of consensus prudent.

The European Association of Endoscopic Surgery (EAES) initiated a consensus development

conference with on endoscopic groin hernia surgery during its annual congress in 2012. The

aim of this conference was to provide practical guidelines employing available medical evidence

combined with the opinions of an expert panel and the membership of the EAES. The findings of

this conference are reported here.

Methods

The coordinator of the consensus development conference (HJB) and two members of the

consensus panel (BvdH and MMP) selected a group of 14 surgeons, representing the European

countries, with both clinical and scientific expertise in groin hernia surgery. Six medical scientists

supported this panel of experts. Key topics were presented, adapted and eventually approved by

the panel of experts. All topics were assigned to two experts and medical scientists.

The medical scientists performed a critical appraisal of the literature and selected the best available

evidence on each topic. A literature search was performed for each specific topic. All the articles

concerning this specific topic were reviewed and articles with the highest level of evidence were

selected. The level of evidence was assessed according to the Oxford classification (Table 1.) (5)

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106 | Chapter 8

The best available evidence was summarized. PubMed and the Cochrane database were used.

BvdH and MMP supervised the medical scientists and checked all the searches and summaries.

A summary of the best available evidence, including complete search and grading of the level of

evidence of each study, was completed and distributed to the experts allotted for that particular

topic two weeks before the first meeting in Amsterdam.

Table 1.Oxford Classification for levels of evidence (also see www.cebm.net)

Level Therapy/Prevention, Aetiology/Harm

Prognosis

1a Systematic Review (with homogeneity) of RCTs SR of inception cohort studies; validated in different populations

1b Individual RCT (with narrow Confidence Interval) Individual inception cohort study with > 80% follow-up; validated in a single population

1c All or none All or none case-series2a SR (with homogeneity) of cohort studies SR (with homogeneity) of either retrospective

cohort studies or untreated control groups in RCTs

2b Individual cohort study (including low quality RCT; e.g., <80% follow-up)

Retrospective cohort study or follow-up of untreated control patients in an RCT.

2c “Outcomes” Research; Ecological studies “Outcomes” Research 3a SR (with homogeneity) of case-control studies3b Individual Case-Control Study4 Case-series (and poor quality cohort and case-

control studies)Case-series (and poor quality prognostic cohort studies)

5 Expert opinion without explicit critical appraisal, or based on physiology, bench research or “first principles”

Expert opinion without explicit critical appraisal, or based on physiology, bench research or “first principles”

First statements were formulated (by HJB) in preparation of the first meeting. These statements

and the summary of the best available evidence on each topic were given to the expert panel at

the first meeting.

On April 20th 2012, 14 members of the expert panel attended a full day meeting. The coordinator

of the consensus development conference HJB chaired the meeting. Each topic was discussed

individually. Discussion was initiated by presenting the summary of the reviewed literature

pertaining to that specific topic by one of the medical scientists. The levels of evidence of

the reviewed manuscripts as determined by the medical scientists were discussed and either

confirmed or modified.

The statement was submitted to all members of the expert panel for acceptance. Statements

were accepted, modified or rejected. Subsequently, each statement was discussed and the level of



8

agreement was determined, if the majority agreed, the statement was accepted in the consensus.

The statements and levels of evidence were distributed among all members of the expert panel

after the meeting for approval. After approval, the topics and statements were posted on the

EAES website prior to the annual conference of the EAES on June 22 2012 in Brussels.

The members of the expert panel presented all topics, statements and associated level of evidence

to an audience of attendees of the EAES conference. Voting pads allowed all present to vote

in favour or against each statement. The level of consensus was determined according to the

classification shown in table 2.

The conference was recorded and was posted on the EAES-website after the congress was

held. EAES members could vote in favour or against the statement through a secured link. Two

reminders to vote were sent by email via the general EAES secretary.

Table 2. Classification of consensus

Strength of consensus Percentage of agreementStrong consensus >95% of participantsConsensus 75-95% of participantsMajority 50-75% of participantsNo consensus <50% of participants

Results

One thousand eighty-one delegates from 82 countries attended the EAES congress in Brussels in

2012. Of these, between 92 and 164 surgeons voted during the consensus conference. After the

conference was posted on the EAES-website, 17 surgeons voted (at least for some statements)

online.

The level of evidence (LoE), as determined by the expert panel, will be provided after each

statement. The level of consensus (LoC/ table 2) will be provided, including the votes in favour of

the statement, the total amount of votes and the calculated percentage.

Factors predisposing to developing groin hernias

The impact of predisposing factors on the development of groin hernias is under debate.

Many clinicians assume that occasional lifting, constipation and prostatism increase the risk for

developing groin hernias. However, evidence is lacking. (6; 7)

A patent processus vaginalis does predispose for developing a groin hernia. (8) Patients who

have ascites, who are treated with intra-abdominal dialysis, who suffer from COPD and those

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108 | Chapter 8

who perform long-term heavy work have an increased risk for developing a groin hernia due

to an elevated intra-abdominal pressure. (6; 7) Surgery in the lower abdomen such as an open

appendectomy or prostatectomy might cause a groin hernia. (6; 7)

Hernias of the abdominal wall represent weakening of the muscular and fascial layers of the

abdominal wall. Collagen is an important cross-link providing strength to such tissues. Therefore,

deficiencies of collagen metabolism may cause hernias. There are twelve types of collagen in

the human body; the proper balance between these individual collagen types is essential to

the strength of the collagen rich tissues. Changes in the collagen metabolism can either be due

to external factors like smoking, or have a genetic predisposition. (6; 7) An altered collagen

metabolism manifested by a decreased type I:III collagen ratio seems to be the underlying biologic

source of abdominal wall hernia formation. (9)

Patients with an abdominal aortic aneurysm (AAA’s) have an increased propensity for abdominal

wall hernia development. In a recent meta-analysis (10) the correlation between AAA’s and

abdominal wall hernias was confirmed. The study compared the incidence of incisional and

inguinal hernias in patients with AAA’s to patients with aorto-iliac occlusive disease (AOD) and

found a relative risk of inguinal hernia of 2.3 (odds-ratio, 2.30; 95% CI, 1.52-3.48; p<0.0001).

Patients with a decreased type I:III collagen metabolism and patients with an abdominal aortic

aneurysm are thought to share a systemic connective tissue defect, affecting the structural

integrity of the aortic and the abdominal wall. The exact pathogenesis is unknown.

In a Swedish cohort study (11) on 1072 HIV-infected male patients on anti-retroviral therapy, an

increased incidence of abdominal wall hernias was reported. The underlying mechanism/cause of

this finding is unknown.

Statements

1. Occasional lifting, constipation and prostatism do not predispose to the development

of groin hernia.

LoE: 3 LoC: majority, 68/110=62%

2. In patients suffering from aneurysmal disease, the incidence of groin hernia is increased.

LoE: 3 LoC: majority, 60/115= 52%

Assessment of groin hernia

In daily practice, the majority of groin hernias can be diagnosed accurately by physical examination.

Imaging studies are only indicated when the presence of a groin hernia is unclear or when the



8

clinician is unsure whether the swelling in the groin is caused by a hernia. (12; 13) However, in

case of groin pain without a swelling at clinical presentation, the diagnosis of a groin hernia by

physical examination can be challenging (14) and additional imaging modalities may be necessary

to identify the actual groin pathology. (15) Herniography, radiography of the pelvic area after

intra-peritoneal injection of radio-opaque dye, has been the standard imaging procedure since

1967. (16) However, this is an invasive procedure with inherent risk of visceral of vascular damage.

A recent review showed an overall sensitivity rate ranging from 81 to 100% and specificity rate

from 92 to 98.4%. Other non-invasive imaging modalities such as ultrasound, CT-scan and MRI

have been evaluated.

A non-contrast CT-scan has an overall accuracy of 94%. (17) A small study (18) confirms the

additional value of MRI when the herniography is unclear in an occult groin hernia. Correlation

with surgical findings showed ultrasound to have a sensitivity of 33% and a specificity of 100%.

(19; 20)

CT-scan and MRI have the advantage above ultrasound and herniography in diagnosing other

causes of groin pathology. Ultrasound has a high specificity, is cheap and is therefore considered

the most cost effective imaging modality in patients with groin hernia.

It is considered difficult to determine whether an inguinal hernia is direct or indirect during physical

examination. (21-23) Some surgeons prefer a precise and detailed preoperative evaluation of the

type of inguinal hernia and advocate the concept of individualized inguinal hernia repair. (15; 24-

29) However, knowledge of the type of inguinal hernia rarely modifies the indication for surgery

and little importance is been given to preoperative differentiation of inguinal hernia type. In

accordance, the majority of the expert panel did not believe that pre-operative knowledge of the

type of hernia would change their surgical approach.

Statements

3. In case of clear clinical diagnosis of inguinal hernia, no additional imaging studies are

necessary.

LoE: 2C LoC: consensus, 137/147=93%

4. When a groin hernia is suspected but clinical findings are equivocal, the first step in

imaging is dynamic ultrasonography, followed by dynamic MRI.


5. Ultrasonography and MRI have a high sensitivity and specificity considering the

detection of an occult inguinal hernia and have replaced herniography as a diagnostic

instrument.


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110 | Chapter 8

6. CT can be a useful adjunct for the detection of an occult groin hernia.

LoE: 3 LoC: majority, 112/152= 74%

7. Physical examination does not allow distinguishing direct i.e. medial from indirect i.e.

lateral inguinal hernias.


Operative or conservative approach of groin hernias and selection of endoscopic

technique.

The general strategy toward groin hernias is surgical repair. The presenting symptom of a groin

hernia is either discomfort or pain in the groin in two-thirds of all patients. (30) One third of all

patients has no symptoms at clinical presentation, but only a sign of a non-tender bulge in the

groin. The rationale to recommend surgery is to prevent visceral incarceration and subsequently

ischemia (strangulation). However, little is known about the natural history of untreated groin

hernias. (31) Recently, two large randomized controlled studies have been published (32; 33)

to analyze the natural course of asymptomatic inguinal hernias. These studies concluded that

watchful waiting was safe in asymptomatic inguinal hernias. However, a later study showed that

the majority of patients with an asymptomatic inguinal hernia eventually becomes symptomatic

and concluded that the evidence for a watchful waiting policy is lacking. (34) The rationale for

surgery in inguinal hernias is, therefore, treatment of current or future symptoms and not to

prevent incarceration.

Considering that most patients with an asymptomatic groin hernia eventually become symptomatic,

an occult contralateral hernia, discovered during endoscopic repair of a symptomatic unilateral

hernia, can be repaired during the same surgical procedure. This can only be done when this

option has been discussed prior to surgery and informed consent was obtained. In absence of

a groin hernia, prophylactic mesh-placement on the contralateral side in endoscopic repair of a

symptomatic unilateral hernia is not advisable.

Femoral hernias seem to incarcerate significantly more than inguinal hernias. The actual risk of

incarceration of femoral hernias has only been described in observational cohort studies, but

shows a 7-8 fold increase compared to inguinal hernias. (31; 35-38) The rationale for surgery in

femoral hernias is therefore to prevent incarceration.

Endoscopic repair can be done for all groin hernias, inguinal and femoral, unilateral and bilateral,

primary and recurrent. The expert panel states that there are no absolute contra-indications for

endoscopic repair in adolescents, age 14 to 18 years. Endoscopic groin hernia in complicated



8

situations, such as in patients after radical prostatectomy or cystectomy, in patients with a scrotal

hernia, ascites, on peritoneal dialysis and redo endoscopic repairs, should only be performed by a

surgeon that has a high level of experience in endoscopic groin hernia repair.

The two major endoscopic techniques are transabdominal preperitoneal repair (TAPP) and total

preperitoneal repair (TEP). In the best available evidence (39; 40), no technique seems to be

superior to the other with regards to outcomes and complication rates. Both techniques were

associated with similar operative time, postoperative complications, postoperative pain, time

to return to work, and recurrences. TAPP was associated with a slightly longer hospital stay

compared with TEP.

Endoscopic groin hernia repair is favored over open groin hernia repair in certain patients.

Endoscopic groin hernia repair is associated with less post-operative pain than open repair. (41-

44) This difference in pain seems to disappear during the first 6 weeks after surgery. Young

active adults benefit mostly from endoscopic groin hernia repair since they gain most from early

convalescence. It is therefore stated that young active adults with a groin hernia are preferably

repaired with an endoscopic technique. Endoscopic surgery is also preferred in patients with

a recurrent groin hernia after open repair. (40) The posterior route is free of scar tissue and

therefore the groin can be reached more easily with an endoscopic approach.

In patients with bilateral groin hernias, the expert group stated that endoscopic repair is ideal

because both groins can be reached using two or three small incisions, whereas in open repair

one large incision in each groin is necessary.

Statements

Recurrent groin hernia

8. Endoscopic surgery is preferred in patients with a recurrent groin hernia after open

repair.

LoE: 1B LoC: strong consensus, 151/158=96%

9. Redo endoscopic repair is only feasible, when the surgeon has a high level of experience

in endoscopic groin hernia repair.

LoE: 5 LoC: consensus 109/134=81%

Bilateral groin hernia

10. Especially in bilateral groin hernia endoscopic surgery is an excellent approach

LoE: 5 for TEP/ 2B for TAPP LoC: strong consensus, 154/161=96%

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112 | Chapter 8

11. Concerning the repair of a bilateral hernia, there is no clear advantage of TEP over TAPP

or vice versa.

LoE: 1A LoC: majority, 105/142=73%

12. When an occult contralateral hernia is discovered during endoscopic repair of a

symptomatic unilateral hernia, the occult and the symptomatic hernia can be repaired

in the same surgical procedure.

LoE: 5 LoC: strong consensus, 148/154=96%

13. In absence of a groin hernia, prophylactic mesh-placement on the contralateral side in

endoscopic repair of a symptomatic unilateral hernia is not advisable.

LoE: 5 LoC: consensus, 124/138=90%

Endoscopic repair in a complex situation

14. In complex situations*, endoscopic hernia repair should only be considered when the

surgeon has a high level of experience in endoscopic groin hernia repair.

LoE: 5 LoC: consensus, 135/152: 89%

*The following situations are considered to be highly complex: patients after radical

prostatectomy or cystectomy, and patients with a scrotal hernia, ascites, previous mesh

repair or peritoneal dialysis.

Endoscopic repair in the young individual

15. Young active adults with a groin hernia are preferably repaired with an endoscopic

technique.

LoE: 1A LoC: consensus, 112/148=76%

16. There are no absolute contraindications for endoscopic repair in adolescents; age 14 to

18 years.


Endoscopic repair of femoral hernias

17. Endoscopic repair is the preferred surgical approach in case of a femoral hernia.

LoE: 5 (men/ 2C (women) LoC: consensus, 108/144=75%

Endoscopic repair of strangulated hernia

The definitions of the terms strangulation and incarceration vary. The EAES consensus group

adheres to the following definition: Strangulation to indicate that there is a bulge in the hernia

sac, but it is reducible. The term incarceration is used for a non-reducible bulge in the groin

In case of strangulation or incarceration, the intra-abdominal cavity should be inspected, followed

by either TEP or TAPP. (45) Incarcerated groin hernias should be operated on urgently to prevent

for ischemia of the incarcerated viscera.



8

Some surgeons dread the use of a mesh in emergency hernia repair, particularly when a bowel

resection is required, because of the fear for a mesh infection. However, there is insufficient

evidence to avoid mesh repair in these situations routinely. Recent studies (46; 47) showed few to

no mesh infections in patients who underwent bowel resection during an emergency endoscopic

procedure.

A recently performed trial (48) randomized patients with spontaneously reduced strangulated

groin hernias to either laparoscopic inspection of the hernia sac and abdominal cavity or to open

inspection of the hernia sac with or without explorative laparotomy (at the surgeon’s discretion).

In the laparoscopy group, 2 out of 21 patients had resections of a necrotic ileal bowel loop during

abdominal inspection. In the open group, 4 out of 20 patients had explorative laparotomy with

2 out of 4 bowel resections. One patient in the open group had a delayed laparotomy because

of missed bowel ischemia.

Overall, the endoscopic approach of incarcerated and strangulated groin hernias allows for

laparoscopic inspection of the intra-abdominal cavity in all patients, hence could prevent for

missed bowel ischemia. The endoscopic repair is therefore the preferred approach.

Statements

8. Repair of incarcerated, non-reducible, groin hernias has to be done urgently and can be

performed with an endoscopic technique.

LoE: 2A LoC: consensus, 124/155= 81%

9. When performing an endoscopic repair, the abdominal cavity should be inspected

followed by either TAPP or TEP.


10. Mesh placement during surgery for strangulated groin hernia is possible in clean-

contaminated situations; i.e. in case of a bowel resection.


11. In suspicion of a strangulated groin hernia, a laparoscopic approach is preferred.


Endoscopic repair of sportsman’s hernia

Among professional athletes, groin pain is a common injury. Causes for chronic groin pain are

lumbar spine problems such as compression syndrome and herniated lumbar disc, leg length

differences, tendinitis of the adductor muscle, osteitis pubis, prostatitis and sportman’s hernia. In

athletes with chronic groin pain, a sportman’s hernia can be diagnosed only when other causes

have been excluded. (49) Because of the large differential diagnosis of groin pain in athletes, it

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114 | Chapter 8

is extremely important to evaluate each patient in whom a sportsman’s hernia is suspected in a

multidisciplinary setting.

Various imaging techniques are used to diagnose a sportman’s hernia, or exclude other causes

of groin pain. (50) The expert panel agreed that MRI is the preferred imaging technique, because

of its capacity to differentiate between several groin pathologies. MRI has the advantage to

work with magnetic fields instead of Xrays, but is expensive and has never been proven the best

technique to diagnose groin hernias.

Several studies have been undertaken over the past few years to define the best treatment

method for sportsman’s hernia. In a prospective randomised setting, the endoscopic TEP mesh

placement was compared with conservative therapy (i.e. rest, physiotherapy, steroid injections

and oral anti-inflammatory analgesics) in 60 athletes with a groin hernia. (51) This study reported

that operative repair was more effective than non-operative treatment for chronic pain after

1 up to 12 months of follow up (p<0.001). Ninety per cent of the patients who underwent

surgery returned to sports activities after 3 months compared to 27% in the conservative group

(p<0.001). Two studies (50; 52) have treated athletes with chronic groin pain unresponsive to

conservative treatment with TEP. In these study groups, 93% to 100% returned to full sports

activity three months after TEP repair.

Statements

12. A multidisciplinary team should evaluate possible sportsman’s hernia in order to exclude

other causes of groin pain such as lumbar spine problem (compression syndrome,

herniated lumbar disc), leg length differences, tendinitis of the adductor muscle, osteitis

pubis or prostatitis. MRI is the preferred imaging modality.


13. Endoscopic placement of a mesh in the groin is effective in athletes with a sportman’s

hernia.

LoE: 1B LoC: consensus, 129/147=88%

Antibiotic prophylaxis

There is very little evidence for the use of antibiotics during endoscopic groin hernia repair. (53)

In open groin hernia repair, the effectiveness of antibiotic prophylaxis in reducing postoperative

wound infection rates has been studied extensively. In 2012, a large Cochrane review was

published concerning this subject. It included 7843 patients from 17 RCTs. It was concluded

that no universal recommendation for antibiotic prophylaxis could be given; neither can it be

recommended against when high infection rates are observed. (54)



8

Statements

14. There is not enough evidence to support the routine use of prophylactic antibiotics in

elective endoscopic groin repair.


Procedural and technical aspects of endoscopic groin hernia repair.

The particular technical details of TEP and TAPP groin hernia repair are beyond the aim of this

manuscript. The choice and fixation of the mesh and how to approach the absence of a hernia

sac during surgery will be discussed in this chapter.

To evaluate the type of mesh used during endoscopic groin hernia repair, a meta-analysis of

lightweight-mesh versus heavyweight-mesh in both TEP and TAPP inguinal hernia repair was

performed. (55) Eight randomized clinical trials were included (56-62), a total of 1667 hernias

in 1592 patients were analysed. The mean study follow-up was between 2 and 60 months. No

significant effect on recurrence, chronic pain, postoperative pain, seroma formation or return to

work was found and both meshes appeared to result in similar long- and short-term postoperative

outcomes. Future long-term analysis of post-operative chronic pain may guide surgeons’ selection

of mesh weight for endoscopic groin hernia repair.

Mesh fixation technique is a frequently studied topic since post-operative pain has become one of

the major outcomes in inguinal hernia surgery. In TAPP repair the mesh is usually fixed with glue,

tackers or staples. In TEP repair, the mesh is not fixed at all, or fixed with glue, tackers or staples.

Several studies have been published concerning the difference between glue and tacker fixation

in TAPP hernia repair with regard to the incidence of recurrences. (63-67) The type of fixation

did not influence the recurrence rate. Also, the type of fixation did not seem to influence acute

or chronic pain. (64-68) Some studies suggest that tacker fixation may lead to higher acute and

chronic pain scores but other studies repudiate this. (66)

Three groups recently performed meta-analyses of the influence of fixation versus non-fixation

of the mesh in TEP repair. (69-71) Only one group reported a difference in chronic post-operative

pain favoring the non-fixation group. (71) The other two (69; 70) did not find any difference in

recurrence rate or (chronic) pain. A recent randomized controlled trial (that was not included

in these meta-analyses) (72) compared post-operative pain between fixation and non-fixation

of the mesh and did not show any difference in acute or chronic pain. Moreover, the incidence

and amount of post-operative pain is also likely to be influenced by the number and location of

tackers/staples.

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116 | Chapter 8

The expert group agreed that diverse types of inguinal hernias (i.e. direct vs indirect and large

vs small hernias) should be distinguished and treated in a different way. Randomised controlled

trials have not differentiated between large and small hernias; the use of a lightweight mesh with

or without fixation of the mesh in case of a large direct (medial) hernia might lead to a higher

recurrence rate.

A prevalent phenomenon during endoscopic repair of a groin hernia is absence of a hernia sac.

Patients present with a bulge in the groin, but during surgical exploration no sac is found. Even

when a sac is absent, herniation through the abdominal wall is not excluded. Preperitoneal fatty

tissue could protrude through an insufficient fascia transversalis as a direct hernia or through

the internal ring along the spermatic cord as an indirect hernia. Inguinal lipomas are therefore

considered to be a pitfall in hernia surgery. (73) The incidence of an inguinal lipoma is around

20% and might be related to BMI. (74-76)

Statements

15. Sufficient overlap of the mesh is more important than fixation of the mesh.


16. There is currently not enough evidence supporting the general use of lightweight mesh

over heavyweight mesh in endoscopic groin hernia repair.


17. The mesh in groin hernia repair measures minimally 15x10cm.

LoE: 5 (TEP)/ 2C (TAPP) LoC: consensus, 136/153=89%

18. The use of a heavy weight mesh, larger mesh size, mechanical fixation and reduction of

the dead space (i.e. fixation of the transversalis fascia) could be considered in patients

with a large medial i.e. direct hernia.


19. Tacker or suture fixation for unilateral groin hernia (with the exception of large direct

inguinal hernias) should be avoided.


20. In absence of a preperitoneal hernia sac, an active search for herniating lipomas should

be done.


21. Herniated adipose tissue present in the internal ring should be reduced.




8

Complications of endoscopic groin hernia repair

Complications after endoscopic groin hernia repair are widely described. The most common

short-term complication is formation of a haematoma or a seroma. The average incidence of

haematoma reported in several randomized controlled trials lies around 8%. (40; 42; 77-85)

The incidence of a post-operative seromas after endoscopic repair is approximately 7%. It is of

great importance to inform patients about the possibility of seroma formation, as seroma is not

a seldom side effect. Patients might confuse the swelling formed by the seroma as a persistent

groin hernia and might conclude that surgery has failed. However, seroma formation most often

lacks clinical significance or clinical relevance. Therefore, all panel members agreed that when

seroma formation occurs, generally, there is no need for aspiration.

In contrast to complications such as haematoma and seroma, wound infection after endoscopic

repair occurs rarely and reported rates are around 1% (40; 42; 77; 79-83; 85-87) Also mesh

infection occurs seldom. A Cochrane review shows that only one mesh infection occurred in 2179

patients who underwent endoscopic groin hernia repair. (40) The expert panel agrees that in case

of a mesh-infection, removal of the mesh is generally not necessary.

A frequently mentioned drawback of laparoscopic repair of an inguinal hernia is the possible

collateral damage of vital adjacent structures such as bowels or vessels. However, no evidence for

such an increased risk of serious collateral damage is supported by the literature. A large meta-

analysis of 2005 comparing laparoscopic inguinal hernia repair versus open repair included about

3500 repairs and analyzed the incidence of collateral damage. In the laparoscopic group (TAPP/

TEP), an incidence was documented of 0.1% of intra-operative bowel lesions, versus 0.06% in

the open group. This difference was not significant. The incidence of vascular damage in the

laparoscopic group was 0.09% versus none in the open. This difference was also not significant.

(79)

The most common long-term complications are recurrence and (chronic) pain. The recurrence rate

after endoscopic surgery is consistently low and varies between 0-4%. (77; 88-90) Chronic pain

on the other hand is a more common adverse outcome of (endoscopic) hernia repair and lacks a

uniform definition. Incidences therefore vary widely, and rates as high as 25% are reported. (77)

The expert panel consented that a proper meta-analysis of the vast amount of studies is needed.

Quality of life and incidence of (acute) pain differ from one technique to the other and might be

influenced by fixation of the mesh and type of mesh. Most studies comparing the effect of open

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118 | Chapter 8

and laparoscopic repair of inguinal hernia on quality of life and pain, favor the latter, because of a

reduction in acute pain. (77; 91-94) However, the difference in post-operative pain scores in favor

of the laparoscopic approach diminishes over time.

Recently more attention is paid to the effect of mesh repair on male fertility. Testicular atrophy,

due to impaired vascularization, and hydrocele are identified as long-term complications after

inguinal hernia repair. A recent study suggests that the use of a mesh causes impaired sperm-

motility. (59) However, in a large epidemiologic study no association has been found between

inguinal hernia repair and increased incidence of infertility. (95)

Statements

Short-term complications

22. Infections of the mesh rarely occur after endoscopic groin hernia repair. In case of mesh-

infection, removal of the mesh is generally not necessary.

LoE low rates: 1A LoC: majority, 103/150=69%

23. Formation of a seroma is a frequent occurrence after endoscopic groin hernia repair but

lacks clinical relevance or significance in most cases. It is advised to explain the possibility

of seroma formation to the patient pre-operatively to prevent anxiety.


24. In general, the aspiration of a seroma is not advised.

LoE: 5 LoC: consensus, 129-157=82%

25. Endoscopic surgeons should strive for wound infection rates below 2% after endoscopic

groin hernia repair.


Long-term complications

26. Endoscopic surgeons should strive for symptomatic recurrence rates below 5% five

years after endoscopic groin hernia repair.


27. Endoscopic surgeons should strive for severe chronic groin pain rates below 2% five

years after endoscopic groin hernia repair.


28. Mesh repair in general does not seem to cause infertility in males.




8

Postoperative considerations in endoscopic groin hernia repair

The general approach towards physical restrictions after groin hernia repair differs considerably.

(96) Many surgeons and general practitioners recommend a few weeks of rest, including no

driving, working or lifting. However, those recommendations seem to depend more on local

tradition than clear evidence and therefore need to be reconsidered. (97)

Studies failed to show any disadvantageous effect of a short period of convalescence with regard

to the development of a recurrence. (98-102) Early and active encouragement of patients after

groin hernia repair is associated with shortened convalescence and earlier return to work. (101)

Hand and foot reaction times return to pre-operative levels 7-10 days after surgery. (103; 104)

The value of follow-up after inguinal hernia repair is unclear. Most studies on this subject stress

the importance of prolonged follow-up for quality assessment of inguinal hernia surgery. These

studies use postal questionnaires to select patients with a suspected recurrence with varying

degrees of success. (105-107) No studies were found on the need for regular check-ups after

inguinal hernia repair, to detect asymptomatic recurrences or prevent incarceration. Therefore,

routine follow-up after groin hernia surgery lacks medical evidence.

Quality assessment after endoscopic inguinal hernia surgery consists of two long-term

complications; recurrence and pain. A variety of questionnaires and tools are being used to assess

the quality of life (QoL) and pain after inguinal hernia repair.

Traditionally, QoL-measurements after surgery were conducted using the generic Short Form-36

(SF-36). (108) The SF-36 is thought to be an adequate tool to measure QoL in patients over time,

but it is too extended and universal to measure specific complaints after a specific treatment.

In addition to general health related quality of life instruments as the SF-36, disease specific

instruments focus on particular health conditions and are useful to detect the changes resulting

from specific treatment. The Carolina Comfort Scale (CCS) was developed as a disease specific

questionnaire for evaluating the QoL after the mesh hernia repair. (109) It evaluates the sensation

of the mesh, pain and movement limitations in different aspects of common daily life. Another

disease specific questionnaire has recently been proposed (110), but it has not been validated yet.

The expert-panel agreed that an internationally accepted hernia-specific questionnaire to monitor

pain and discomfort after inguinal hernia repair is necessary.

For the evaluation of pain, the Visual Analogue Scale (VAS) is often used, although the Verbal

Rating Scale (VRS) might be better for post-herniorrhaphy pain assessment. (111) The Visual

Analogue Scale (VAS) for pain can be used when specific cut-off points are used to define mild,

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120 | Chapter 8

moderate and severe pain. Another questionnaire that has been used for pain-assessment is

the Inguinal Pain Questionnaire that has been proven a reliable instrument to assess pain after

inguinal hernia repair. (112)

Statements

Patient encouragement / advise

29. Active encouragement after groin hernia repair is associated with shortened

convalescence.


30. Early activity after groin hernia repair does not seem to increase recurrence rates.


Follow up

31. Routine follow-up after (endoscopic) groin hernia repair is not necessary*.


*Consensus Conference Brussels: follow-up is necessary to assess incidence of recurrence and

chronic pain.

Quality of life

32. Quality of life after endoscopic hernia repair is generally excellent in most patients.


Educational, organizational and financial aspects of endoscopic groin hernia repair

Competency in surgery is of great importance for patient safety. In endoscopic surgery of groin

hernias, competency has not been consistently defined. Hence, it is very difficult to determine the

criteria for reaching full competency. Endoscopic groin hernia repair is considered more difficult

than open groin hernia repair. The number of procedures needed to reach full competency

(formerly known as learning curve) is dependent on several factors such as previous experience

and type of training method.

The existing literature reflects mostly series of hernia surgeries performed by a single surgeon or a

small group of surgeons who adopted the technique of endoscopic surgical repair of hernias in a

non-structured fashion. The results of individual surgeons have been analysed in large retrospective

(113-115) and prospective studies. (116; 117) These studies showed significant reduction of

operating times, conversion rates and complication rates after 30 to 100 TEP procedures and

50 to 75 TAPP procedures. These studies reveal that the number of cases required to accomplish

competency is determined by various factors such as previous experience with other minimally

invasive procedures and experience in open groin hernia surgery.



8

An American group (118; 119) demonstrated that surgeons in training reach competence

after fewer cases, in a structured educational programme. Development of structured training

programs is therefore mandatory to improve the efficacy of educational modules and increase

patient safety.

Clear evidence supporting centralisation of hernia repair in specialized hospitals is not available.

However, one study (118) demonstrated that centralisation of hernia repair within one hospital

by referring all patients with hernias to a single dedicated surgeon resulted in fewer wound

infections (5.9% to 0.45%, p <0.005), fewer systemic complications (2.05% to 0.45%, p < 0.05)

and lower recurrence rates (4.6% to 0.45%, p < 0.001).

The use of evidence-based protocols for hernia repair result in lower perioperative complications

rates (2.16%) and lower recurrences rates (0.78%). (120) These results favour specialization in

and centralization of hernia care.

Endoscopic groin hernia repair is more expensive compared to open groin hernia repair. The

increased costs are particularly due to the need of special equipment and general anaesthesia.

Costs of disposable devices and operating time can be calculated accurately while determination

of costs of personnel and amortization of non-disposable equipment is more difficult. Calculation

of indirect costs is even more complex, because methods of estimating lost income vary. In the

available literature, the direct medical costs of laparoscopic inguinal hernia repair were higher than

those of open repair. (41; 77; 78; 91; 121-133) When including societal costs, total costs were

often similar or lower after endoscopic repair. (6; 94; 134-138) Costs will become progressively

important in healthcare. Overall calculation of costs however is very complex and is therefore

prone to bias.

Statements

Training and competency in endoscopic groin hernia repair

33. Endoscopic groin hernia repair is considered to be more complex than open groin hernia

repair.


34. Broad implementation of a structured educational program in endoscopy is recommended

to familiarize surgeons in training with endoscopic surgery and to prevent rare but

serious complications of vascular damage or bowel perforation.

LoE: 5 LoC: strong consensus, 126/133=95%

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122 | Chapter 8

35. Numbers needed to reach competence in endoscopic groin hernia repair will decrease

when participating in a structured educational programme.

LoE: 2C LoC: strong consensus, 127/133=95%

36. Specializing in groin hernia repair promotes standardizing peri-operative care, which

reduces morbidity and lowers the recurrence rate.


37. Numbers needed to reach competence in TAPP-repair appear to be lower than for TEP-

repair.


Costs

38. Total costs of endoscopic groin hernia repair appear to be similar to those of open

repair: direct costs are higher while indirect costs are lower.


Discussion

Consensus, which we defined as agreement among at least 75 percent of participants in

the consensus conference, was reached in three-quarters (36/48) of the statements. Five of

36 statements with consensus were supported by level 1 evidence while 21 statements with

consensus were based on level 5 evidence, illustrating the paucity of high level evidence for

endoscopic repair of groin hernias. Interestingly, the degree of consensus for level 1 statements

was 63 percent (5/8) and 84 percent (21/25) for level 5 statements. Apparently, high level

of evidence statements are not consistently associated with strong consensus of the surgical

community and vice versa.

The existing guidelines published by the EHS and IEHS both are based on review of the literature by

a small group of experts without formal contributions of their members. Several surgical scientists

s of the EHS and IEHS were included in the expert panel of the EAES consensus development

conference to ensure a platform consisting of representatives from all societies with a special

focus on groin hernia surgery. Combining medical evidence with the opinions of both experts and

the surgical community provides a unique method to develop best practice guidelines.



8

A limitation of this study is the involvement of less than 10 percent (of approximately 2700)

of the EAES member. To increase involvement, the statements of the consensus development

conference were posted on the EAES website four weeks before the meeting in Brussels. In

addition, a recording of the consensus development conference was posted on the EAES website

after the meeting with a digital voting module to allow members who could not attend the

conference to contribute. In spite of the limited number of members that used this opportunity,

employment of digital communication methods deserves further attention to reach out to those

who can not readily attend conferences in person.

In conclusion, more than three-quarters of surgeons involved in the 2012 EAES consensus

development conference agreed on three-quarters of 48 statements regarding endoscopic repair

of groin hernias. Collaboration between all societies with a focus on groin hernias such as the

EAES, EHS and IEHS, high caliber scientific studies on groin hernias and including opinions and

experiences of the surgical community at large are the elements to further improve the quality of

care for our patients with groin hernias.

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139. Vale L, Grant A, McCormack K, Scott NW, and EU Hernia Trialists Collaboration. Cost-effectiveness of alternative methods of surgical repair of inguinal hernia. Int J Technol Assess Health Care. 2004;20(2):192-200.

140. McCormack K, Wake BL, Fraser C, Vale L, Perez J, and Grant A. Transabdominal pre-peritoneal (TAPP) versus totally extraperitoneal (TEP) laparoscopic techniques for inguinal hernia repair: a systematic review. Hernia. 2005, May;9(2):109-14.

141. Kuhry E, van Veen RN, Langeveld HR, Steyerberg EW, Jeekel J, and Bonjer HJ. Open or endoscopic total extraperitoneal inguinal hernia repair? A systematic review. Surg Endosc. 2007, Feb;21(2):161-6.

Chapter 9

Summary and Discussion

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Summary and Discussion | 135

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Summary

The research described in this thesis started with a retrospective analysis of 101 patients whose

hernia was repaired with the use of an onlay mesh technique (chapter 2). Wound infection was

reported in 21% of the patients, seroma was reported in 27% of the patients. Recurrence was

found in 16% of the patients who were seen at follow-up (n=71). This modified onlay mesh

technique seems to be an acceptable and easy technique for large and/or more complicated

incisional hernias, especially since it is not necessary to enter the abdominal cavity. The outcomes

do not differ from the results of other accepted open techniques such as the component

separation technique.

Health related quality of life (HRQL) was examined in the patient group that had their incisional

hernia repaired by a large onlay mesh (chapter 3). The Short Form 36 and the Karnofsky

performance status scale were used as tools to measure quality of life. A matched population

was obtained from the Netherlands Cancer Institute to perform a matched control analysis. No

difference in HRQL could be found. Onlay incisional hernia repair therefore does not seem to

affect HRQL.

While retrospectively studying patients treated for large incisional hernias, several patients who

were treated with an open abdomen were identified. Literature about this topic is limited and the

number of patients treated with an open abdomen is low, it is therefore impossible to perform

a randomized controlled trial or conduct a meta-analysis. A retrospective analysis to study this

group of patients was started (chapter 4). The manuscript aims to analyze patients who were

treated with an open abdomen in a university hospital and a large teaching hospital and to study

the existing literature concerning open abdomen treatment. There is no evidence to advocate

a certain treatment strategy. Temporary fascial closure with the aim to achieve a delayed fascial

closure is a demanding and expensive treatment. Anticipating on a planned ventral hernia is an

easier to perform and less demanding technique for severely ill patients, and might therefore be

the best treatment strategy there is so far. The hernia can be repaired or treated conservatively

after the patient recovered.

In current surgical practice, there is ongoing discussion about the possible benefits and

disadvantages of laparoscopic incisional hernia surgery. Scientific evidence is lacking to determine

whether laparoscopic correction is superior to conventional open techniques. This study will

provide evidence on the effectiveness of laparoscopic incisional hernia repair as compared

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to open repair. Also, there is a need to know the natural course of a conservatively treated

incisional hernia. Registration of all patients with an incisional hernia could therefore be valuable.

Furthermore, we want to know what type of incisional hernia is treated with what type of surgical

repair, to find out if subgroups could be created with an individual treatment advice. A large

randomized controlled trial comparing the efficacy of open and laparoscopic incisional hernia

repair was initiated. Patients who do not participate in the INCH trial will be registered in a

database. This study is called ‘INCH trial’ (chapter 5). Guidelines about whether a patient can

be treated with the use of laparoscopy are non-existent. The INCH study group decided to leave

the decision at the discretion of the surgeon. The participating surgeons are hernia experts and

performed at least fifty laparoscopic incisional hernia repairs each.

To be able to measure disease specific quality of life in the INCH trial, authors validated the Carolina

Comfort Scale (CCS) in Dutch (chapter 6). The CCS is a questionnaire designed specifically to

measure quality of life in patients undergoing mesh hernia repair. It was developed and validated

in English by Heniford et al (ref). The questionnaire was translated into Dutch and tested on a

hundred patients undergoing mesh hernia repair within one week after surgery. Patients were

asked to complete the short Form 36 and to repeat the CCS three weeks after surgery. The

Dutch CCS appears a valid and clinically relevant tool for assessing quality of life after repair of

abdominal wall hernia with mesh. It will therefore be used in the INCH trial.

Recommendations or standardization of the open technique that can be used in the INCH trial is

hard to give, as there is not enough evidence to support a certain open procedure. Onlay, sublay

and component separation technique appear to be equally effective. Laparoscopic repair has not

been standardized either.

A review of the literature was performed to evaluate the surgical technique of laparoscopic

incisional hernia repair with outcomes, to define the optimal technique (chapter 7). The use of

transfascial sutures, the amount of overlap of the mesh of the fascia and the type of mesh used

were analyzed. No specific parameter could be identified to influence the recurrence rate.

The use of a mesh with sufficient overlap (preferably >5cm in each direction) of the mesh of the

fascia was the only mandatory factor in the INCH trial in each chosen technique, as in general,

this is thought to reduce the recurrence rate.

While starting the INCH trial, the EAES consensus development conference 2012 on endoscopic

groin hernia repair was organized. With the use of available medical evidence combined with

the opinions of an expert panel and the membership of the EAES, practical guidelines on how to



9

handle a groin hernia could be formulated (chapter 8). A consensus development conference can

be a very valuable tool especially in topics where evidence based medicine is lacking.

Conclusions

The following conclusions may be drawn from the studies in this thesis.

- The onlay technique for the repair of (large) incisional hernias is an acceptable method

(chapter 2).

- Onlay incisional hernia repair does not seem to (negatively) affect the health related

quality of life (chapter 3).

- The best treatment modality for patients treated with an open abdomen is yet to be

found (chapter 4). Absorbable mesh closure, i.e. Vicryl, is a good option in severely ill

patients where delayed fascial closure it not the main concern.

- The Dutch Carolina Comfort Scale is a reliable instrument to measure quality of life in

patients treated with mesh hernia repair in the Dutch-speaking population (chapter 6).

- No recommendations can be drawn from a systematic review of over 2000 patients

concerning the influence of surgical technique of laparoscopic incisional hernia repair

on recurrence rate (chapter 7).

- A consensus development conference can be a very valuable tool especially in topics

where evidence based medicine is lacking (chapter 8)

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Discussion

Reconstruction of the abdominal wall is complex given the multiple functions of the abdominal wall

and its intricate anatomy. Available surgical methods to restore the abdominal wall are limited to

sheets of synthetic material, which are a pale shadow of the multilayer flexible architecture of the

abdominal wall. Hence, it is not surprising that the outcomes of current incisional hernia surgery

are mediocre. Due to impaired healing of laparotomies in more than 15 % of patients, incisional

hernias are a frequent disorder affecting the quality of life of many patients. Close evaluation of

the outcomes of various employed techniques is mandatory to identify the technique with the

best ratio between outcomes and morbidity.

Research on abdominal wall hernia repair gravitates to the management of groin hernia. The aim

of research in inguinal hernia repair has shifted from prevention of recurrences to minimizing

chronic post-operative pain and the effects on other quality of life parameters. Research on

incisional hernia repair still focuses on decreasing post-operative morbidity and reduction of

the recurrence rate. More research needs to be done in order to optimize the surgical care of

patients suffering from an incisional hernia. Morbidity and recurrence rate is unacceptably high

at 15-20%. The introduction of laparoscopic incisional hernia repair might improve outcomes

such as wound-infections and hospitalization in patients with hernias suitable for laparoscopic

surgery. Nonetheless, it is unknown if the functional outcome or quality of life improves with the

application of the laparoscopic repair. Also, there will still be patients with incisional hernias that

cannot be repaired by the use of the laparoscopic repair, such as patients with large complicated

abdominal wall defects.

General surgeons have performed surgery for abdominal wall hernias for centuries. Incisional

hernias can be repaired using open or laparoscopic techniques. The indication for repair, as well as

the choice for the open or the laparoscopic approach is unclear. Surgeons choose their technique

based on their previous experience, characteristics of the abdominal wall hernia, patient history,

available equipment and prosthesis. This choice is far from evidence based. It is only possible to

find the best treatment option for different kind of patients with abdominal wall hernias through

doing more research.

The interaction between mesh, its fixation and the physical properties of the abdominal wall

constitute as system, which is referred to by Bittner et al as the ‘mesh-fixation-abdominal wall

system (1). These three elements need to be evaluated interdependently to determine the optimal

treatment strategy. Evaluating one of these in isolation will not reveal clinically relevant results as

shown in chapter 7.



9

In general, surgeons assume that an overlap of the mesh of the defect needs to be at least 5cm.

The mesh usually shrinks after implantation in the abdominal wall and therefore a wide overlap is

needed. Nevertheless, when the hernia is at the periphery of the abdominal wall, it is sometimes

impossible to reach 5cm of overlap because of the proximity of the skeletal structures.

Fixation of the mesh to the abdominal wall in open hernia repair is usually not an issue because

the mesh is held in position between the different layers of the abdominal wall in the sublay

technique. In laparoscopic repair tackers and/or transfascial sutures fixate the mesh to the

abdominal wall. The fixation should suffice preventing (early) recurrences, while too many tackers

or sutures can increase post-operative pain.

The employment of a prosthetic mesh during incisional hernia repair either open or laparoscopic

techniques, is known to lower the recurrence rate (2). Prosthetic meshes are available in many

different shapes and sizes. Although much emphasis is put on the use of prosthesis, the use

of mesh is not the main reason for an effective hernia repair. It is all about the “mesh-fixation-

abdominal wall” system. Properties of the mesh (porosity, elasticity, and the architecture of the

weave) do influence this system, but the individual patient characteristics probably contribute

equally. Body Mass Index, age and gender influence the anterior abdominal wall movements.

Also, histological features, like collagen structure of the individual abdominal wall vary. Because of

these individual variances, forces acting on the prosthesis used to repair the abdominal wall differ.

The material used for abdominal wall reinforcement should therefore be more individualized.

Tailor-made meshes based on the individual body shape, fascial structure and anterior abdominal

wall imaging (by a 3D printer) are the future. However, the exact methods to enable the creation

of a tailor-made mesh are unclear.

Several (open) surgical techniques are available for the repair of large incisional hernias with loss

of domain. The open component separation technique is a frequently used surgical technique

for these large hernias. The muscular layers of the abdominal wall are dissected to enlarge

the muscular abdominal wall surface. The tissue damage is substantial and the vascularization

might get compromised, which probably affects the abdominal wall function post-operatively.

Laparoscopic component separation technique seems to be feasible, probably reduces wound-

healing problems and might therefore improve functional outcome.

The modified onlay technique described in chapter 2 and 3 does not require separation of the

muscular layers. It does involve separation of the subcutaneous tissue from the fascia. Therefore,

clinical relevant seromas occur more frequently. The advantage of this procedure is that it is a

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140 | Chapter 9

fast and simple technique and it does not require entering the abdominal cavity. Recurrence rates

after this onlay repair are comparable to other open techniques. The technique does not seem

to (negatively) affect the quality of life for these patients. Abdominal wall function has not been

examined; patients do report to feel the mesh in certain movements after this modified onlay

incisional hernia repair.

Hybrid techniques, combining open and laparoscopic techniques, gain popularity in the repair of

large incisional hernias. Intra-abdominal adhesions can be reduced and the fascial edges can be

brought together with the use of the open approach, while the mesh can be positioned and fixed

to the abdominal wall using the laparoscopic approach.

The surgical techniques that are used to repair an abdominal wall hernia need to be more uniform.

Standardizing surgical techniques is a necessary method to improve the quality of care that we

provide to patients with incisional hernias. There is no gold standard for incisional hernia repair

and the accepted available techniques used by general surgeons differ from one to another. The

term ‘incisional hernia’ is probably too general. Specific types of incisional hernias and patients

with such a hernia should be distinguished in order to be able to make a tailor made treatment

strategy for each subgroup.

Surgical residents should be trained in abdominal wall hernia repair. A structured laparoscopic

training program in hernia repair improves surgeons’ proficiency in the operating room. The

learning curve for incisional hernia repair is unclear. Outcomes are thought to improve by surgeon

volume. Therefore, experienced hernia surgeons should perform complex abdominal wall hernia

repairs.

The International Endohernia Society recently published the fist guidelines for laparoscopic

incisional hernia repair (1,3,4). These guidelines help us to clarify some topics, but many questions

remain unanswered. Thorough registries of patients with incisional hernias who undergo surgical

repair and of those who abstain from surgery, such as the EuraHS and HerniaMed, are of great

importance to learn more about the outcomes of surgical and non-surgical management of

incisional hernias. These databases might help surgeons to choose the proper material and

technique to repair a hernia. Randomized trials are needed to know what type of incisional hernia

is suitable for what surgical technique and the effect on morbidity such as recurrence rate and

quality of life. The INCH trial, a randomized controlled trial and registry that started July 2012,

aims to find answers to these questions.



9

References

1. Bittner R, Bingener-Casey J, Dietz U, Fabian M, Ferzli G, Fortelny R, et al. Guidelines for laparoscopic treatment of ventral and incisional abdominal wall hernias (international endohernia society [IEHS])-part III. Surg Endosc 2014, Feb;28(2):380-404.

2. Luijendijk RW, Hop WC, van den Tol MP, de Lange DC, Braaksma MM, IJzermans JN, et al. A comparison of suture repair with mesh repair for incisional hernia. N Engl J Med 2000, Aug 10;343(6):392-8.

3. Bittner R, Bingener-Casey J, Dietz U, Fabian M, Ferzli GS, Fortelny RH, et al. Guidelines for laparoscopic treatment of ventral and incisional abdominal wall hernias (international endohernia society [IEHS])—part 2. Surg Endosc 2014, Feb;28(2):353-79.

4. Bittner R, Bingener-Casey J, Dietz U, Fabian M, Ferzli GS, Fortelny RH, et al. Guidelines for laparoscopic treatment of ventral and incisional abdominal wall hernias (international endohernia society (IEHS)-part 1. Surg Endosc 2014, Jan;28(1):2-29.

Chapter 10

Nederlandse samenvatting

Dankwoord

Curriculum Vitae

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Nederlandse samenvatting | 145

10

Nederlandse samenvatting

Een littekenbreuk is een defect (ook genaamd hernia of breuk) in de bindweefsellaag (fascie)

van de buikwand dat ontstaat na een buikoperatie. De huid en het onderhuidse vetweefsel zijn

meestal intact, waardoor de inhoud van de buik beschermd is. De opening in de fascie wordt

de breukpoort genoemd. Door deze breuk kan er een zwelling in de buikwand ontstaan, die

veroorzaakt wordt door het uitpuilen van de inhoud van de buik. Deze zwelling is met name

zichtbaar en voelbaar wanneer patiënten staan of hoesten.

Een littekenbreuk komt voor bij 10-15% van de patiënten na een buikoperatie en is vaak

asymptomatisch, maar kan zorgen voor pijn of ongemak. Daarnaast kunnen mensen het lelijk

vinden. Het beklemd raken (‘stranguleren’) van een deel van de (dunne) darm in de breukpoort

is de meest gevreesde complicatie. Het is onbekend wat het precieze verloop is van een patiënt

met een littekenbreuk die niet wordt behandeld.

Een littekenbreuk beïnvloedt de kwaliteit van leven. Littekenbreuken komen vaker voor bij obese

patiënten en nadat er een postoperatieve wondinfectie is geweest. Waarschijnlijk spelen nog

onbekende afwijkingen in de opbouw van bindweefsel een rol in het ontstaan van een hernia in

de buikwand.

Een littekenbreuk kan door middel van een standaard open operatie worden verholpen. Daarbij

wordt het eerdere litteken gebruikt, wordt het gat in de fascie vaak gesloten met hechtingen en

de buikwand verstevigd met een kunststof matje. Deze operatie kan op verschillende manieren

uitgevoerd worden, waarbij met name de positie van de mat in de buikwand verschilt. Dit wordt

aangeduid door de termen ‘onlay’ en ‘sublay’.

Naast de standaard open methode, kan de littekenbreuk ook met een kijkoperatie worden

verholpen. We noemen dat ‘laparoscopisch’. Van binnen uit wordt dan de opening in de fascie

opgezocht, verklevingen worden los gemaakt en er wordt een kunststof matje over de hernia

geplaatst.

In dit proefschrift, getiteld ‘buikwandbreuken, verbetering van chirurgische zorg’, is een aantal

onderzoeken beschreven. Het onderzoek is gestart met een retrospectieve analyse van 101

patiënten wiens littekenbreuk gecorrigeerd was door middel van de (open) gemodificeerde onlay

mesh techniek (hoofdstuk 2). Doel was de uitkomsten na te gaan en die te vergelijken met

andere open technieken. Wondinfecties na deze operatie werden gerapporteerd in 21% van de

patiënten, klinisch significante seromen kwamen voor bij 27% van de patiënten. Bij 16% van

de patiënten werd in de follow-up een recidief vastgesteld (n=71). Deze gemodificeerde onlay

mesh techniek lijkt een acceptabele methode om grote en/of gecompliceerde littekenbreuken te

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corrigeren, met name omdat het niet nodig is de buikholte in te gaan. De uitkomsten verschillen

niet van andere geaccepteerde open methoden, zoals de component separation technique, die

eveneens worden gebruikt om met name grote littekenbreuken te corrigeren.

In de patiëntengroep bij wie hun littekenbreuk gecorrigeerd was met behulp van de gemodificeerde

onlay mesh techniek, werd de ziekte-gerelateerde kwaliteit van leven onderzocht (hoofdstuk 3).

De Short Form 36 en de Karnofsky Performance Status Scale zijn gebruikt om de kwaliteit van

leven te meten. Er werd een gematchte populatie verkregen via het Nederlands Kanker Instituut

(NKI) om zo het verschil tussen deze groepen te kunnen bekijken. Er werd geen verschil gevonden

in de ziekte gerelateerde kwaliteit van leven. De gemodificeerde onlay mesh techniek lijkt daarom

de ziekte gerelateerde kwaliteit van leven niet te beïnvloeden.

Tijdens het retrospectief analyseren van patiënten met een littekenbreuk werden verscheidene

patiënten met een open buik behandeling geïdentificeerd. Een open buik behandeling betekent

dat de buikwand open blijft en de buikinhoud zichtbaar is. Deze behandeling wordt het liefst

vermeden, maar soms is er niets anders mogelijk, omdat bijvoorbeeld door een verhoogde druk

in de buik de buikwand niet meer gesloten kan worden. Het gaat meestal om zeer ernstig zieke

patiënten, die vaak op de intensive care opgenomen liggen. De buikwand van mensen met een

open buik moet op een bepaalde manier bij elkaar gehouden worden. Het is onduidelijk wat

de beste manier is om dat te doen. Daarnaast is het de vraag of de tijdelijke bedekking een

uitgesteld sluiten van de buik moet faciliteren.

Er is weinig literatuur over deze patiënten en de aantallen patiënten die behandeld worden met

een open buik zijn te laag om naar deze patiënten een gerandomiseerde studie te verrichten.

Derhalve werd er en retrospectieve analyse verricht naar deze patiëntengroep (hoofdstuk 4). Deze

studie heeft als doel om de patiënten te analyseren die in een groot perifeer opleidingsziekenhuis

(het Medisch Centrum Alkmaar) en een academisch ziekenhuis (het VU Medisch Centrum)

een open buik behandeling ondergingen. De bestaande literatuur betreffende de open buik

behandeling werd daarnaast bestudeerd.

Er bestaat geen bewijs welke behandelingsmodaliteit het beste is voor deze patiënten. Over het

algemeen zijn er twee scholen: zij die in dezelfde opname de buikwand gesloten willen krijgen en

zij die dat niet als doel hebben. Het tijdelijk sluiten van de fascie met een vacuüm systeem, heeft

als doel om de buikwand uitgesteld dicht te krijgen. Dit is een dure methode die belastend is voor

de patiënt. Anticiperen op een geplande grote littekenbreuk, en het dus open laten van de fascie,

is veel minder belastend voor deze patiënten. Daarom lijkt deze behandeling ons tot dusver

de beste keuze. Wanneer de patiënt is hersteld kan de littekenbreuk desgewenst gecorrigeerd

worden.


Nederlandse samenvatting | 147

10

In de huidige chirurgische praktijk is er blijvende discussie over de voor- en nadelen van de

laparoscopische littekenbreukcorrectie ten opzichte van de open littekenbreukcorrectie. Er is

onvoldoende bewijs om te stellen dat de laparoscopische techniek beter is dan de open techniek.

Daarnaast is het nuttig om te weten wat het natuurlijk beloop van een conservatief behandelde

littekenbreuk is, iets dat in de literatuur niet of nauwelijks beschreven wordt. Registratie van

patiënten met een littekenbreuk is daarom waardevol. Daarnaast willen we graag weten welk

type littekenbreuk behandeld wordt met welk type chirurgische correctie. Zo kunnen we kijken

of er subgroepen gemaakt kunnen worden en of per subgroep een behandel advies gegeven kan

worden.

Er werd daarom een studie opgezet met als doel bewijs te leveren over de (kosten-)effectiviteit

van de laparoscopische littekenbreukcorrectie vergeleken met de open littekenbreukcorrectie.

De belangrijkste uitkomstmaat is om te meten of patiënten na een laparoscopische

littekenbreukcorrectie significant korter in het ziekenhuis opgenomen zijn. Patiënten die niet

participeren in het gerandomiseerde deel van de studie worden geregistreerd in een database.

Deze studie heet de ‘INCH trial’ (hoofdstuk 5). De studie loopt momenteel in een groot aantal

ziekenhuizen in Nederland, we hopen over een aantal jaar de uitkomsten te kunnen rapporteren.

Meer informatie kunt u vinden via www.inchtrial.nl.

Omdat er geen richtlijnen zijn over welke patiënt met een littekenbreuk behandeld kan worden

door middel van een laparoscopische chirurgische correctie, heeft de INCH studiegroep besloten

deze beslissing over te laten aan de behandelend chirurg. Daarnaast zijn er verschillende open

chirurgische technieken om littekenbreuken te corrigeren met vergelijkbare resultaten. Welke

open techniek gebruikt wordt in de INCH trial wordt daarom eveneens aan de behandeld

chirurg overgelaten. De laparoscopische techniek om littekenbreuken te corrigeren is evenmin

gestandaardiseerd. In de INCH trial is de enige vereiste het gebruik van een kunststof mat met

een minimale overlap van 5cm over de fascie, omdat over het algemeen gedacht wordt dat

dit de recidief kans verlaagt. Alle participerend chirurgen hebben tenminste 50 laparoscopische

littekenbreukcorrecties verricht en veel van hen zijn hernia experts.

Om de ziekte specifieke kwaliteit van leven te kunnen meten in de INCH trial is de Carolina

Comfort Scale (CCS) in het Nederlands gevalideerd (hoofdstuk 6). De CCS is een vragenlijst die

ontworpen is om de ziekte specifieke kwaliteit van leven te meten bij patiënten die een correctie

van hun buikwandhernia ondergaan met gebruik van een kunststof matje. De lijst is in de VS

ontworpen en gevalideerd door Heniford et al. De vragenlijst werd vertaald en getest in patiënten

die een liesbreuk, navelbreuk of littekenbreuk correctie ondergingen. Aan 100 patiënten werd

gevraagd om 1 en 3 weken na hun operatie de vragenlijst in te vullen. De Nederlandse CCS bleek

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een valide en klinisch relevante vragenlijst om de ziekte specifieke kwaliteit van leven te testen in

patiënten die een correctie ondergingen van hun buikwandhernia. De CCS zal derhalve gebruikt

worden in de INCH trial.

Getracht werd na te gaan of bepaalde chirurgische aspecten van de laparoscopische

littekenbreukcorrectie invloed hebben op het onstaan van een recidief littekenbreuk. Er werd

daartoe een review verricht (hoofdstuk 7). Het gebruik van transfasciale hechtingen, de mate van

overlap van de mat over de fascie en het type mat werden geanalyseerd. Er werd geen specifieke

parameters geïdentificeerd die het ontstaan van een recidief beïnvloeden.

Terwijl de INCH trial werd opgezet organiseerden wij de EAES Consensus Development

Conference over de endoscopische behandeling van liesbreuken. De laatste jaren zijn er twee

richtlijnen verschenen betreffende de behandeling van liesbreuken: één werd opgesteld door de

European Hernia Society (2009) en één door de International EndoHernia Society (2011). Beide

richtlijnen beschrijven het beste bewijs. Daar waar dat ontbreekt, beschrijft het de mening van

een groep hernia experts.

De aanvullende waarde van het organiseren van een Consensus Development Conference was

met name om te kijken wat de algemene opinie is over onderwerpen waar het aan evidence

ontbreekt.

In deze Consensus Development Conference werd de meest recente en best aanwezige

wetenschappelijke bewijsvoering gecombineerd met de opinie van een expert panel en de leden

van de EAES (chapter 8).


Dankwoord | 149

10

Dankwoord

Het boek is af! Toen Peter van den Akker eens tijdens de borrel zei dat ik alleen mocht meepraten

over promoveren als ik ‘t zelf ook had gedaan nam ik mij voor een boek te schrijven. De afgelopen

jaren werkte ik daarom naast mijn opleiding tot chirurg aan dit zogenoemde ‘hobby-project’, ook

wel ‘werkstuk’ genoemd door mijn moeder. Dit proefschrift is tot stand gekomen met de hulp

van vele mensen, die ik allemaal wil bedanken, een aantal in het bijzonder.

Dr. W.H. Schreurs, lieve Hermien, mijn werkmoeder. Ruim 7 jaar geleden nam je me aan als

ANIOS in het Medisch Centrum Alkmaar en hielp je me aan een onderwerp om onderzoek naar

te doen. De basis voor dit proefschrift werd gelegd.

Ik bewonder je om je chirurgische kwaliteiten, je gave om het beste uit mensen te halen en

om je girl power. Ik ben je erg dankbaar voor het vertrouwen dat je altijd in me hebt gehad, de

kansen die je me geboden hebt en de chirurgische lessen die je me hebt geleerd. Zonder jou was

‘t niets geworden. Met een lach op mijn gezicht denk ik terug aan de afgelopen jaren. Ik hoop

je in de toekomst nog vaak te zien en te spreken en wie weet af en toe nog eens een aquarium

te ontdekken.

Prof H.J. Bonjer, lieve prof, ondanks jouw drukke agenda, maar met name dankzij jouw

wetenschappelijke gaven is ‘t gelukt; het boek is af. Bedankt voor alle mogelijkheden die je

me hebt gegeven om mezelf te ontwikkelen. Zowel op wetenschappelijk als op politiek als op

chirurgische vlak heb ik veel van je geleerd. Wat heerlijk dat je altijd denkt in mogelijkheden en

jonge mensen betrekt en aanspreekt alsof het je gelijken zijn.

De INCH trial is nog in volle gang, dus we hebben nog wel wat te doen. Hopelijk pakken we

die ZonMW! Ik ga mijn carrière nu eerst vervolgen daar waar jouw roots liggen, in Rotterdam.

Ik hoop je in de toekomst geregeld te zien en te spreken, of het nou over motorboten of over

wetenschap gaat!

Drs. B.L.A.M. Langenhorst, lieve BLAM, ik weet dat je geen wetenschapper bent. Toch ben je vaak

het best op de hoogte van de nieuwste wetenschappelijke bevindingen binnen jouw vakgebied

en gaf je aanzet tot het schrijven van dit proefschrift. Met al je zo typerende, niet altijd even

zachtzinnige uitspraken heb ik me de afgelopen jaren goed vermaakt. Ik zal nooit meer een dikke

vrouw kunnen opereren zonder aan je te denken. Bedankt voor alle wijze lessen die je me hebt

geleerd. Ik hoop dat we die eetafspraak nu nog eens maken!

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Prof J. Jeekel, beste professor, elke keer dat wij elkaar zien vertelt u mij hoe waardevol het is dat

er ‘van dit soort spontane meisjes’ doordringen in de chirurgie. Ik vat dat op als een compliment.

Het is al jaren geleden dat u tegen me zei, “als er ooit een boek komt, dan moet je me wel vragen

voor de commissie!”. Zie hier, het boek is af en ik voel mij zeer vereerd dat u in de commissie

plaatsneemt.

Prof G. Kazemier, beste Geert, wat een prettige verrassing om je tijdens een tweede ronde VUMC

te leren kennen, niet alleen vanwege de chirurgische lessen, maar ook vanwege de gezelligheid.

Ik heb veel geleerd van je kennis, kunde en je kijk op de wereld. Hoewel ik mijn carrière richting

de 7 stuur (in jouw ogen het hoogst haalbare in de periferie) bewonder ik jouw grenzeloze drive

om de 10 te zijn. Ik hoop je nog vaak tegen te komen voor een rondje slap ouwehoeren, maar

ook voor serieus advies. Bedankt dat je wil plaatsnemen in mijn commissie.

Prof. M.A. Cuesta, beste Miguel, wat een geluk dat ik nog door je ben opgeleid en een stukje

van je kunde mee kan nemen in mijn verdere carrière. Het ‘knuffelen met die weefsels’ schiet

vaak door mijn hoofd als er een stukje van de operatie even lastig is. Ook bij het gebruik van een

Vicryl mat denk ik aan jou. Ik bewaar goede herinneringen aan een skivakantie waar Jaap Bonjer,

jij en ik de rest waren kwijtgeraakt en ons een dag lang hebben vermaakt met skiën, stiekeme

borreltjes in de lift en het eten van taartjes bij de open haard. Ik hoop op dat glas witte wijn op

een terras in het Vondelpark. Bedankt dat je in mijn commissie wilt plaatsnemen.

Prof. J. Lange, beste professor, zijdelings hebben we elkaar vaak gezien, direct herinner ik mij

met name één keer. Het was in Rotterdam, waar ik bij Jaap achterop de NS-scooter naar het

restaurant kwam waar we, samen met Joost Bruggeman gingen eten. Scooters en Scaffolds werd

de werknaam. Fantaseren over allerlei (wetenschappelijke) projecten blijft heerlijk om een avond

mee te vullen. Dank dat u plaats wilt nemen in mijn commissie.

Prof. H. van Goor, u viel mij op vanwege uw wat oostelijk klinkende accent, wat een beetje voelde

als thuis. U blijkt inderdaad uit Zwolle te komen, waar ook mijn roots liggen. Wellicht dat het

mij ook daarom een goed idee leek u voor mijn commissie uit te nodigen. Veel dank dat u de

uitnodiging geaccepteerd heeft. Natuurlijk zal ik luisteren naar de inhoud van uw vragen en niet

naar uw uitspraak;)


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Dr. B.J. Dwars, lieve Dr.D! Wat een feest om je in de buurt te hebben en heerlijk om je af en toe

te kunnen huggen. Bedankt voor de gezellige borrels en etentjes in binnen- en buitenlandse

steden. Ik hoop dat we elkaar nog vaak tegen zullen komen. Bedankt dat je er bent nu ik mijn

proefschrift ga verdedigen.

Aan mijn voormalig bazen in het Medisch Centrum Alkmaar. Ik heb genoten van alle serieuze en

gezellige momenten in een ziekenhuis dat voelt als mijn tweede thuis. Ik ben er klaar voor om

nu als chirurg aan de slag te gaan en het nest uit gegooid te worden. Bedankt daarvoor. Ik hoop

jullie nog vaak te zien en te spreken.

Stafleden VUMC, bedankt voor de academische verrijking en gezelligheid tijdens mijn jaren in het

VU Medisch Centrum. Misschien heeft het zo moeten zijn dat er weer eens iemand van 020 naar

010 gaat in plaats van andersom. Lang leve de Zuidas.

Aan al mijn (oud-)collega’s in het VUMC en MCA; heel veel dank voor de gezellige opleidingsjaren.

Een paar mensen wil ik in het bijzonder bedanken. De slechte mensen club; Ivar, Ruby en Paula,

voor een heerlijk begin van de opleiding met jullie aan mijn zij. Hoewel het leven is veranderd

(jee wat zijn we oud aan het worden..) hoop ik snel weer eens een borrel met jullie te drinken.

De mannen uit de tijd van de mannen, Nike Hanneman, Gisela Moormann, David Heineman

en Joost Bruggeman, je weet toch. Boffen was dat. Nike, wat fijn om zoveel jaar samen onze

opleiding te volgen. Bedankt voor alle gezelligheid de afgelopen jaren. Wat een feest dat we nu

weer samen gaan werken, ik zie er naar uit!

Babs Zonderhuis, ik kwam je tegen in de VU.. net zo’n regelnicht als ik en nog gezellig ook. Wat

fijn dat je m’n vriend werd.

Baukje van den Heuvel, wat een gezelligheid dat jij ook naar de VU kwam vanuit Maastricht. Als

geen ander begreep jij hoe heftig het is om naast je opleiding ook te promoveren. Ik hoop dat ik

in de buurt kom van jouw fantastische prestatie van afgelopen winter.

Nadine, Charlotte en Jort, zoals jullie weten blijf ik graag betrokken bij alle ins en outs van de

INCH trial, maar ik ben heel blij dat jullie de praktische uitvoering van mij hebben overgenomen.

Bedankt!

Nadine, zet m op met dat boek over de buikwand, je kunt het!

Elly de Lange en Tjeerd van der Ploeg, bedankt voor de statistische hulp bij al het onderzoek.

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Ron de Hoon, Annemarie Kerstens en het secretariaat chirurgie, met name Ilse Kruit; bedankt

voor de ondersteuning, adviezen en hulp in het VUMC. Jullie maken het leven makkelijker.

Medewerkers poli chirurgie van het Medisch Centrum Alkmaar, en in het bijzonder Yvonne

Ottenbros, bedankt voor het maken van alle controle afspraken, opvragen van statussen en

andere secretariële klussen. Het is een verademing dat jullie zo lekker proactief zijn.

Inge Schouten, Judith Spronk en Peter de Mooij, heel veel dank voor alle ondersteuning bij vele

aspecten van het onderzoek en al het geregel er omheen.

Aan mijn lieve vrienden, bedankt dat ik bijna nooit met jullie over onderzoek hoefde te praten.

Erg lief dat jullie af en toe vroegen waar het ook alweer over ging en dat dan ook onthielden. Ik

voel mij een gelukkig mens met jullie om mij heen.

In het bijzonder:

Berber en Maartje, jullie zijn als mijn familie, bedankt voor de onvoorwaardelijke liefde en steun.

Michiel en Yvonne, wat heerlijk dat we het leven een beetje kunnen delen.

Jeroen en Ron, ik hoop dat we nog jaren samen blijven feesten, dank dat jullie er zijn.

Evelien, ik vind het fijn dat we elkaar zo goed blijven begrijpen, dank dat je m’n vriend bent.

Paranimfen

Lieve Yvonne, al jaren praten we over relaties, studie, carrière, geluk, ambitie, familie, vrienden en

hoe dat samengaat. Het leek mij daarom een voor de hand liggende keuze om jou te vragen om

mijn paranimf te zijn. Dank dat je me, ook op het moment van mijn verdediging bijstaat.

Lieve Swa, mijn zusje, Maartje Nijlpaard. Je moet niet denken dat het wegpoetsen van mijn S

in verhouding staat tot het wegpoetsen van jouw S. Ik ben trots op hoe je het leven het hoofd

biedt en heel blij dat je tijdens mijn verdediging naast me wilt staat. Dr(s) P & Dr(s) P forever!

Ik hou van jou.

Lieve Arjen en Bas, dank dat we het zo goed hebben samen. Bijzonder is dat.

Lieve Wilma en Roel, wat fijn dat jullie mijn nieuwe familie zijn.

Lieve Stan, het heeft een tijdje geduurd voor wij elkaar op waarde konden schatten, maar het

resultaat is er. Dank voor je rust, interesse en zorgzaamheid. Dank dat je mamma zo gelukkig

maakt.


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Lieve mamma, wat jammer dat pappa er niet is, de zoveelste mijlpaal zonder hem. Hij weet vast dat

we het goed doen en is daar ongetwijfeld trots op. Ik bewonder je om je doorzettingsvermogen,

je gave de kleine dingen te zien en om je onuitputtelijke attentheid. Bedankt dat we het samen

zo goed hebben. Ik hou van jou.

Liefste Margo, you and me. Het leven is zoveel leuker met jou. Ik hou van je.

James, wat een feest dat je in ons leven bent gekomen, ik hoop dat we nog oneindig veel plezier

gaan beleven samen.

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Curriculum Vitae | 155

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Curriculum Vitae

Marijn Poelman werd op 5 juni 1981 geboren in Groningen als oudste dochter van Nelleke

Trooster en Martin Poelman. Nadat ze haar jeugd in Zwolle had doorgebracht en daar haar

Atheneum diploma behaalde, ging ze in 1999 geneeskunde studeren in Maastricht. Tijdens haar

studie geneeskunde genoot zij met volle teugen van het studentenleven en reisde veel. Ze volgde

delen van haar studie in de Phillipijnen, Spanje en Ecuador.

Na het afronden van haar studie begon zij in 2006 als ANIOS heelkunde voor de tropenopleiding

in het Tergooi Ziekenhuis in Blaricum, waar al doende steeds duidelijker werd dat zij verder wilde

in de chirurgie. Met dat doel voor ogen werd zij ANIOS heelkunde in het Medisch Centrum

Alkmaar, waar al vrij snel de basis voor dit proefschrift werd gelegd.

In januari 2008 startte zij met de opleiding tot chirurg in het Medisch Centrum Alkmaar (opleider

dr. W.H. Schreurs) en het VU Medisch Centrum (opleider prof.dr. J.A. Rauwerda/dr. D.L. van

der Peet). Tijdens haar opleiding heeft zij het onderzoek naar mensen met een littekenbreuk

voorgezet, wat geresulteerd heeft in dit proefschrift.

Zij heeft haar opleiding tot gastro-intestinaal chirurg in mei 2014 afgerond. Ze is in juni 2014

gestart als chef de clinique bij Maatschap Chirurgen Rotterdam Zuid.

Marijn woont samen met Margo Dijkman en hun zoon James in Amsterdam.

ABDOMINALWALL

HERNIAImproving surgical care

Marijn Poelman

ABD

OM

INA

L WA

LL HERN

IA Im

proving surgical care M

arijn Poelman

Uitnodiging

Voor het bijwonen van de openbare verdediging van mijn proefschrift getiteld

Abdominal Wall Hernia


Op vrijdag 26 september 2014 om 13.45 uur in de Aula van

de Vrije Universiteit.De Boelelaan 1105,

1081 HV in Amsterdam.

Receptie na afloop ter plaatse

Promovenda:Marijn Poelman

Gerard Brandtstraat 3-41054JH Amsterdam

[email protected]

Paranimfen:Maartje Poelman

[email protected] Bors

[email protected]

De pdf van het proefschrift is te downloaden op:

www.inchtrial.nl

Improving surgical care HERNIA

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