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Treatment of the complex abdomen and acute intestinal failure

de Vries, F.E.E.

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Citation for published version (APA):de Vries, F. E. E. (2018). Treatment of the complex abdomen and acute intestinal failure.

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5SYSTEMATIC REVIEW AND META-ANALYSIS OF

THE REPAIR OF POTENTIALLY CONTAMINATED

AND CONTAMINATED ABDOMINAL WALL DEFECTS

The American Journal of Surgery 2017 Sep;225:371-379

J.J. AtemaF.E.E. de VriesM.A. Boermeester

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ABSTRACT

Background – Repair of contaminated abdominal wall defects entails the dilemma of choosing between synthetic material, with its presumed risk of surgical site complications, and biologic material, a costly alternative with questionable durability.

Data sources – Thirty-two studies published between January 1990 and June 2015 on repair of (potentially) contaminated hernias with ≥25 patients were reviewed. Fifteen studies solely described hernia repair with biologic mesh, 6 nonabsorbable synthetic meshes, and 11 described various techniques. Surgical site complications and hernia recurrence rates were evaluated per degree of contamination and mesh type by calculating pooled proportions.

Conclusions – Analysis showed no benefit of biologic over synthetic mesh for repair of potentially contaminated hernias with comparable surgical site complication rates and a hernia recurrence rate of 9% for biologic and 9% for synthetic repair. Biologic mesh repair of contaminated defects showed considerable higher rates of surgical site complications and a hernia recurrence rate of 30%. As only 1 study on synthetic repair of contaminated hernias was available, surgical decision making in the approach of contaminated abdominal wall defects is hampered.

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REPAIR OF POTENTIALLY CONTAMINATED AND CONTAMINATED ABDOMINAL WALL DEFECTS

109

INTRODUCTION

A defect or hernia of the abdominal wall is a frequently encountered surgical problem, with approximately 10 000 incisional hernia repairs being performed in the United Kingdom each year1.

It is currently accepted that only very small hernias are eligible for simple suture repair while all others should preferably undergo mesh repair to reduce recurrence rates2. Potential or certain contamination of the surgical wound, however, poses a dilemma as the use of non-absorbable synthetic material is historically considered contraindicated given the risk of postoperative infectious complications and need for mesh removal. The introduction of biologic meshes has provided an alternative. Derived from biologic material, these meshes theoretically incorporate into native tissue and possess the ability to resist infection.

Multiple reports on the use of biologic mesh in abdominal wall repair have been made. The Ventral Hernia Working Group (VHWG) has recommended its use for the repair of potentially contaminated and contaminated hernias in 20103. Furthermore, a potential advantage of biologic over synthetic material was even suggested for patients at high risk of developing surgical site complications. More recently, however, enthusiasm for biologic mesh in abdominal wall repair has somewhat damped4,5. The recommendations of the VHWG were mainly based on expert opinion and not on high quality evidence, and there is still a lack of consensus among surgeons regarding the appropriate indications for biological mesh use6-8. Especially the durability of biologic mesh repair is subject of debate9. Furthermore, the assumed drawback of synthetic material in contaminated fields has become less rigid as several authors have proclaimed safe usage, particularly employing new light-weight synthetic meshes10.

The aim of this review was to critically assess available literature on (potentially) contaminated hernia repair, and to evaluate whether biologic mesh, with the assumed ability to resist infection, enables a durable method of repair and whether synthetic mesh offers a safe treatment option.

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METHODS

This systematic review and meta-analysis was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRIMA) guideline11.

Literature search To identify relevant articles a systematic electronic search was conducted in the following databases: MEDLINE, Embase and the Cochrane Central Register of Controlled Trials (CENTRAL). For each database a search strategy was constructed by using a combination of medical subject headings (MESH) and free-text terms related to repair of abdominal wall hernias and the presence of contamination. No search terms with regard to surgical techniques or mesh types were used to ensure finding all reports with use of every possible technique or mesh. Two independent reviewers assessed all identified abstracts (J.J.A and F.E.E.d.V). Subsequently, full-texts of potentially relevant articles were obtained. After full text selection a cross-reference search was conducted to find any additional relevant articles. The latest literature search update was done on the first of June 2015.

Study selectionTo be included studies had to report on the single-stage repair of abdominal wall defects complicated by the presence of contamination. Contamination was considered present when the defects were classified as clean-contaminated (class II), contaminated (class IIII) or dirty-infected (class IV) according to the US National Research Council Group wound classification12, potentially contaminated (grade III) or infected (grade IV) according to the Ventral Hernia Working Group (VHWG) grading system3, or contaminated (grade III) according to the modified VHWG grading system13. Repairs were also considered contaminated when synchronous enteric fistula takedown, infected synthetic mesh removal or concomitant bowel surgery was performed. Merely describing defects as ‘complicated’ or ‘complex’ in a study was insufficient since multiple definitions exist14. Reports on parastomal hernia repair, stoma site closure, burst abdomen repair, early repair of open abdomens (delayed fascial closure within initial admission) and prophylactic mesh insertion were not eligible for inclusion. Studies on the surgical repair of enteric fistula were only included if data on abdominal wall defect and repair was specifically given. If studies described various types of abdominal wall defects, i.e. both clean and contaminated, data on patients fulfilling the aforementioned inclusion criteria were derived separately. If this was not possible, studies were only included if the majority (≥75%) of the described patients fulfilled the inclusion criteria. Only studies published after 1990 in English with a full-text available (no conference abstracts) were considered for inclusion. Furthermore, studies had to encompass 25 patients or more. If multiple studies reported on the same patient population, or showed significant overlap, the most relevant study was included. In case of


5


111

indistinctness regarding overlap or duplicate study populations, corresponding authors were contacted.

Data extractionThe following data were extracted using a preformatted datasheet: year of publication, study period, study design and number of patients. Patient and hernia characteristics that were extracted included: age, gender, body mass index (BMI), defect size, and details regarding contamination. The following surgical characteristics were extracted: setting (acute or elective), surgical approach (open or laparoscopic), type and method of component separation (anterior or posterior and open or endoscopic), type of mesh, mesh position and whether or not primary fascial closure was achieved. Different types of mesh were broadly classified into synthetic or biologic. Synthetic meshes were further subdivided into absorbable or non-absorbable. Non-absorbable meshes were categorized based on their material; polypropylene (lightweight or heavyweight when specified), polyester, polyethylene and polytetrafluoroethylene (expanded or non-expanded when specified)15. If synthetic meshes were coated (i.e. composite mesh) this was additionally reported. Biologic meshes were categorized based on their source (human, porcine or bovine), material (dermis, submucosa) and whether or not they were chemically cross-linked. Mesh positions were categorised as onlay, inlay, retro-rectus, intra-peritoneal onlay (IPOM), and underlay when it was unclear if a mesh was placed retro-rectus or IPOM. Relevant outcome variables were length of follow-up and the number of surgical site complications including wound infection (superficial and deep), seroma, postoperative enteric fistula and overall surgical site complication rate. Rate of mesh removal and hernia recurrence rate was also extracted. If studies reported on different surgical techniques or mesh types separately, outcome data was extracted and reported per technique if subgroups consisted of 25 patients or more. If different mesh types were used as part of a treatment algorithm only overall data was used.

Quality assessmentThe methodological quality of the included studies was assessed with use of a tool based on The Cochrane Collaboration’s tool for assessing risk of bias (Appendix 1)16. The first two items of the original Cochrane tool (sequence generation and allocation concealment) were replaced with items addressing inclusion criteria and selection criteria for the used surgical techniques and meshes, as randomized controlled trials were lacking. Whether or not outcomes of the individual studies were defined based on specific criteria was additionally assessed. Finally, any industry funding or other declared conflict of interest was evaluated.

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Statistical analysisOutcome data of the included studies were pooled and evaluated per mesh type (synthetic and biologic) and degree of contamination (clean-contaminated or potentially contaminated and contaminated or infected). Studies describing synchronous bowel resection were classified as potentially contaminated, whereas studies on simultaneous fistula takedown were categorised as contaminated. If studies described both clean-contaminated and contaminated repairs, the degree of contamination of the majority of repairs determined in which category a study was analysed. For the analysis of hernia recurrences, only studies with a mean or median follow-up of at least one year were analysed. Hernia recurrence rates of studies with a reported primary fascial closure rate of less than 75% were analysed and reported separately. Pooled weighted proportions with corresponding 95% confidence intervals (CI) were calculated with use of an inverse variance method (random-effects model) in R statistical software. Heterogeneity of the included studies was evaluated by calculating the I2

statistic. I2 describes the percentage of total variation across studies due to heterogeneity rather than chance. The value of I2 lies between 0% and 100%, with a value of 0% indicating no observed heterogeneity, and larger values indicating increasing heterogeneity.

RESULTS

The literature search identified a total of 5623 abstracts (Figure 1). After removal of duplicates and screening of titles and abstracts, 362 were obtained as full-text article. A total of 32 studies fulfilled the inclusion criteria and were included in this review. The majority of the articles that were excluded based on full-text lacked information on the level of contamination of the described hernia repairs, or included less than 75% patients fulfilling the inclusion criteria and did not report data on eligible patients separately.


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113

122

Figure 1 Flow diagram depicting search and study selection

Records identified through database searching

(MEDLINE n = 2919)

(Embase n = 2628) Additional records identified through

other sources (n = 1)

Records after duplicates removed(n = 4476)

Records screened(n = 4476)

Records excluded(n = 4114)

Full‐text articles assessed for eligibility (n = 362)

Full‐text articles excluded (n = 330)

Studies included in qualitative synthesis

(n = 32)

Studies included in quantitative synthesis (meta‐

analysis) (n = 21)

Figure 1 Flow diagram depicting search and study selection

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Study characteristics and quality assessmentThe included studies were all published between 2005 and 2015 (Table 1). Twenty studies were retrospective observational studies, whereas eleven studies described retrospective analyses of prospectively collected data9,17-26. Only one study was conducted as a prospective observational study27. From ten studies subgroup data on patients fulfilling the inclusion criteria was derived separately18,22,25,26,28-33. The remaining 22 studies comprised patients undergoing abdominal wall repair of whom at least 75% fulfilled the inclusion criteria. Two studies compared different techniques (porcine versus human derived biologic mesh and mesh versus no mesh) and the subgroups were included separately34,35.

All of the included studies were at high risk of bias or unclear on one or more items of the quality assessment tool (for details see Appendix 1). A clear description of selection of techniques and mesh types within studies was only found in 11 studies. More than half of all studies lacked definitions on the main outcomes. Industry funding or other conflicts of interest were reported in 11 studies, of which 8 described the use of a biologic mesh. In addition, 8 studies were unclear on any potential conflict of interest.

Patients and hernia characteristicsThe 32 studies included a total of 6170 patients (Table 1). Mean age ranged from 44 to 64 years in the individual studies. The reported mean BMI of the described patients ranged from 24.4 to 43.0 kg/m2. In 14 studies hernias were classified according to the US National Research Council Group wound classification9,17,18,20,25,27,28,30,31,34,36-39. In eight studies the grading system according to the VHWG was used22-24,26,27,29,33,40, whereas one study used the modified grading scale36. Eleven studies fulfilling the inclusion criteria of this review described specific causes of contamination; two studies described hernia repair with simultaneous bariatric surgery41,42, four studies reported on enteric fistula takedown with abdominal wall repair19,21,43,44, and five studies described hernia repair with concomitant bowel resections for various indications32,35,45-47.


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115

Tabl

e 1.

Stu

dy a

nd p

atie

nt c

hara

cter

istic

sRe

fere

nce

Year

Stud

y ty

peTy

pe o

f m

esh†

N

o. o

f pat

ient

sM

ean

age

in y

ears

(± S

D o

r ran

ge)

Wou

nd c

lass

59 in

%H

erni

a G

rade

3 in

%Sp

ecifi

c ca

uses

of

cont

amin

atio

nI

IIIII

IVI

IIIII

IVAl

tom

2820

12Re

trosp

ectiv

eM

ixed

46 (o

f 149

5)na

010

00

0-

--

--

Bast

a3620

14Re

trosp

ectiv

eBi

olog

ic37

53 (±

15)

2443

1914

-38

‡62

‡na

‡-

Brah

mbh

att26

2014

Retro

-pro

spec

tive

Biol

ogic

38 (o

f 77)

64 (±

1.2)

--

--

-11

5337

-Br

ahm

bhat

t2920

14Re

trosp

ectiv

eSy

nthe

tic27

(of 2

01)

58 (3

9-72

)-

--

-0

010

00

-Ca

rbon

ell17

2013

Retro

-pro

spec

tive

Synt

hetic

100

60 (±

13)

042

580

--

--

-Ch

an41

2014

Retro

spec

tive

Synt

hetic

4550

.7 (2

8-68

)-

--

--

--

-36

(80%

) BR

Choi

1820

12Re

tro-p

rosp

ectiv

e M

ixed

3901

(of 3

3832

)na

099

10

--

--

-Co

nnol

ly19

2008

Retro

-pro

spec

tive

Mix

ed61

mdn

50

(20-

60)

--

--

--

--

63 (1

00%

) EFT

Dia

z Jr

.3720

09Re

trosp

ectiv

eBi

olog

ic24

052

.2 (±

15.0

)21

4720

12-

--

--

El-G

azza

z4520

13Re

trosp

ectiv

eM

ixed

2550

.8 (±

12.7

)-

--

--

--

-25

(100

%) B

R an

d/or

EFT

El-G

azza

z4620

12Re

trosp

ectiv

eSy

nthe

tic40

61 (±

12.5

)-

--

--

--

-40

(100

%) B

RG

arve

y2520

14Re

tro-p

rosp

ectiv

eBi

olog

ic18

8 (o

f 359

)60

.2 (±

12.1

)0

100

00

--

--

-G

uerr

a4020

14Re

trosp

ectiv

eBi

olog

ic44

57.5

(34-

80)

--

--

020

5624

-H

an3;

2320

14Re

tro-p

rosp

ectiv

eBi

olog

ic63

mdn

57

(IQR

46-6

7)-

--

-0

079

21-

Hel

ton30

2005

Retro

spec

tive

Biol

ogic

31 (o

f 53)

na0

393

58-

--

--

Iacc

o3420

14Re

trosp

ectiv

eBi

olog

ic12

461

.9 (±

13.7

)18

2158

3-

--

--

Biol

ogic

127

61.3

(±14

.6)

1717

5114

--

--

-Io

n3120

13Re

trosp

ectiv

eSy

nthe

tic56

(of 4

88)

62.3

(44-

78)

010

00

0-

--

--

Itani

2720

12Pr

ospe

ctiv

eBi

olog

ic80

52 (±

14)

049

493

00

7525

-Ki

m20

2006

Retro

-pro

spec

tive

Biol

ogic

2954

(19–

87)

1745

334

--

--

-Kr

pata

2120

13Re

tro-p

rosp

ectiv

eBi

olog

ic37

58.6

(±14

.3)

--

--

--

--

37 (1

00.0

%) E

FTLe

2220

13Re

tro-p

rosp

ectiv

eM

ixed

171

(of 5

64)

na-

--

-0

075

25-

Liu43

2009

Retro

spec

tive

Oth

er41

44 (1

7-69

)-

--

--

--

-41

(100

%) E

FTPi

nell-

Whi

te32

2014

Retro

spec

tive

Biol

ogic

32 (o

f 82)

53.7

--

--

--

--

32 (1

00%

) BR

Prav

een42

2012

Retro

spec

tive

Synt

hetic

36(2

9-66

)-

--

--

--

-36

(100

.0%

) BR

Rose

n920

13Re

tro-p

rosp

ectiv

eBi

olog

ic12

858

.2 (±

13.5

)0

3439

27-

--

--

Sbita

ny24

2013

Retro

-pro

spec

tive

Biol

ogic

4152

.4 (±

10.2

)-

--

-0

088

12-

Shah

3820

11Re

trosp

ectiv

eBi

olog

ic58

57.2

1660

1212

--

--

-Sl

ater

4420

15Re

trosp

ectiv

eSy

nthe

tic39

61.2

(30-

81)

--

--

--

--

39 (1

00%

) EFT

Van

Gef

fen39

2005

Retro

spec

tive

Synt

hetic

2649

(30-

74)

00

8515

--

--

-W

ind47

2009

Retro

spec

tive

Synt

hetic

32m

dn 4

3 (1

9-78

)-

--

--

--

-32

(100

%) E

FT a

nd/o

r ST

Won

3320

15Re

trosp

ectiv

eU

ncle

ar49

(of 1

36)

57.2

--

--

00

8416

-Xo

uraf

as35

2010

Retro

spec

tive

Mix

ed51

59 (1

7-93

)-

--

--

--

-51

(100

%) B

RN

one

126

61 (3

0-89

)-

--

--

--

-12

6 (1

00%

) BR

SD =

sta

ndar

d de

viat

ion,

na

= no

t ava

ilabl

e, m

dn =

med

ian,

BR

= bo

wel

rese

ctio

n, E

FT =

ent

eric

fist

ula

take

dow

n, S

T =

stom

a ta

kedo

wn.

† Typ

e of

mes

h us

ed

for a

ll or

a p

ortio

n of

incl

uded

pat

ient

s; d

etai

ls a

re g

iven

in T

able

2,3

and

4. ‡ A

ccor

ding

to th

e m

odifi

ed V

HW

G g

radi

ng s

yste

m13

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Surgical techniques and characteristicsFifteen studies described hernia repair with biologic mesh in all patients9,20,21,23-27,30,32,34,36-38,40 (Table 2). Of these, eight used one specific type of biologic mesh; non-cross-linked porcine dermis (StratticeTM)24,27,40 (3), non-cross-linked human dermis (Alloderm® and Ruinuo®)20,23,37 (3), non-cross-linked porcine intestinal (Surgisis® Gold)30 (1) and a porcine dermal mesh of unknown type26 (1). The study by Iacco et al. compared two groups of patients who underwent repair with either a cross-linked porcine dermal mesh (PermacolTM) or a non-cross-linked human dermal mesh (Alloderm®)34. Of the studies on biologic mesh use, ten described repair of clean-contaminated or potentially contaminated hernias with prospectively collected data in half of the studies. Five studies included hernia repairs with synchronous fistula or ostomy takedown and bowel resections24,32,36-38, and one study selectively described repair of incarcerated abdominal wall hernias23. The other studies did not specifically describe the reasons of contamination. No study reported on laparoscopic hernia repair. Five studies described biologic repair of contaminated hernias.

Six studies described hernia repair with non-absorbable synthetic mesh in all patients17,29,31,41,42,46, with three studies describing the use of a specific type of synthetic mesh; lightweight polypropylene17,44, heavyweight polypropylene46 or composite lightweight polypropylene42 (Table 3). These non-absorbable synthetic mesh studies seemed to have included more favourable patients, predominantly clean-contaminated areas, compared with biologic mesh studies in clean-contaminated or potentially contaminated hernias. Only one study on synthetic mesh reported on repair of contaminated defects17. The remaining five studies described clean-contaminated hernias, all with retrospectively collected data. Three of these studies selectively reported on laparoscopic ventral hernia repair, with two studies describing hernia repair with simultaneous laparoscopic bariatric surgery41,42, and one study reporting on laparoscopic hernia repair with ‘no concomitant procedures’29. The other two studies on synthetic repair of hernias classified as clean-contaminated described 40 patients undergoing concomitant bowel resection46, and 56 patients undergoing synchronous visceral surgery including hysterectomy and cholecystectomy31.


5

117

Tabl

e 2.

Sur

gica

l cha

ract

eris

tics

and

outc

ome

of s

tudi

es d

escr

ibin

g bi

olog

ic m

esh

repa

ir in

all

patie

nts

Refe

renc

eN

o. o

f re

pairs

CS

%Ty

pe o

f CS

Type

of m

esh†

%M

esh

loca

tion

%Fa

scia

l cl

osur

e %

Mea

n fo

llow

-up

in m

onth

s (±

SD

or ra

nge)

Wou

nd

infe

ctio

n%

Sero

ma

%

EF %

SSO %

Mes

h re

mov

al†

%

HR %

Clea

n-co

ntam

inat

ed o

r pot

entia

lly c

onta

min

ated

Bast

a3673

57%

na78

% c

ross

-link

ed p

orci

ne d

erm

is (P

erm

acol

)16

% n

on-c

ross

-link

ed b

ovin

e de

rmis

(Sur

gim

end)

5% o

ther

bio

logi

c

100%

IPO

M0%

12.7

22%

8%0%

62%

0%19

%

Brah

mbh

att26

38na

-10

0% p

orci

ne d

erm

is (u

nkno

wn

type

)na

nam

dn 1

5 (1

-30)

‡na

nana

na0%

0%D

iaz

Jr.37

240

13%

Ope

n AC

S or

‘ope

n bo

ok’

100%

non

-cro

ss-li

nked

hum

an d

erm

is (A

llode

rm)

38%

und

erla

y, 37

%

inla

y, 12

% o

nlay

, 13%

un

derla

y/on

lay,

1%

unkn

own

na31

7 (±

269,

9-

1161

) day

s40

%13

%12

%na

na17

%

Gar

vey25

188

76%

na50

% n

on-c

ross

-link

ed p

orci

ne d

erm

is (S

trat

tice)

37%

non

-cro

ss-li

nked

bov

ine

derm

is (S

urgi

men

d)9%

non

-cro

ss-li

nked

hum

an d

erm

is (A

llode

rm)

100%

und

erla

y90

%26

.4 (±

18.8

)14

%7%

2%29

%1%

10%

Gue

rra40

4596

%na

100%

non

-cro

ss-li

nked

por

cine

der

mis

(Str

attic

e)87

% IP

OM

, 13%

retro

-re

ctus

89%

17 (m

dn 1

2,

rang

e 1-

48)

9%11

%na

nana

9%

Han

3;23

6325

%O

pen

ACS

100%

non

-cro

ss h

uman

der

mis

(Rui

nuo)

100%

IPO

M10

0%m

dn 4

3 (2

4-69

)2%

5%0%

nana

16%

Kim

2029

100%

Ope

n AC

S10

0% n

on-c

ross

-link

ed h

uman

der

mis

(Allo

derm

)10

0% IP

OM

na18

2 (1

0-49

1)

days

41%

0%0%

45%

0%11

%

Pine

ll-W

hite

3232

56%

na50

% n

on-c

ross

-link

ed h

uman

der

mis

(Allo

derm

)41

% n

on-c

ross

-link

ed p

orci

ne d

erm

is (S

trat

tice)

9% o

ther

bio

logi

c

88%

und

erla

y, 12

%

onla

y47

%20

28%

9%3%

66%

na28

%

Sbita

ny24

4195

%O

pen

ACS

100%

non

-cro

ss-li

nked

por

cine

der

mis

(Str

attic

e)10

0% u

nder

lay

95%

2515

%7%

nana

0%12

%Sh

ah38

5819

%O

pen/

endo

AC

S50

% n

on-c

ross

-link

ed h

uman

der

mis

(Allo

derm

)28

% n

on-c

ross

-link

ed p

orci

ne in

test

inal

(Sur

gisi

s)14

% n

on-c

ross

-link

ed p

orci

ne d

erm

is (S

trat

tice)

9% c

ross

-link

ed p

orci

ne d

erm

is (6

0% P

erm

acol

, 40

% C

olla

men

d)

17%

onl

ay, 3

6% IP

OM

, 47

% ‘b

ridgi

ng’

53%

1235

%9%

nana

17%

28%

Cont

amin

ated

or i

nfec

ted

Hel

ton30

31na

-10

0% n

on-c

ross

-link

ed p

orci

ne in

test

inal

(S

urgi

sis

Gol

d)10

0% u

nder

lay

nam

dn 1

4 (ra

nge

2-29

)‡na

nana

na16

%26

%

Iacc

o3412

4na

-10

0% c

ross

-link

ed p

orci

ne d

erm

is (P

erm

acol

)57

% in

lay,

39%

IPO

M,

5% o

nlay

43%

mdn

26

(12–

44)

nana

na48

%11

%32

%

127

na-

100%

non

-cro

ss-li

nked

hum

an d

erm

is (A

llode

rm)

74%

inla

y, 25

% IP

OM

, 1%

onl

ay26

%m

dn 1

8 (ra

nge

7–38

)na

nana

30%

9%47

%

R1R2R3R4R5R6R7R8R9


118

Refe

renc

eN

o. o

f re

pairs

CS

%Ty

pe o

f CS

Type

of m

esh†

%M

esh

loca

tion

%Fa

scia

l cl

osur

e %

Mea

n fo

llow

-up

in m

onth

s (±

SD

or ra

nge)

Wou

nd

infe

ctio

n%

Sero

ma

%

EF %

SSO %

Mes

h re

mov

al†

%

HR %

Itani

2780

65%

na10

0% n

on-c

ross

-link

ed p

orci

ne d

erm

is (S

trat

tice)

60%

IPO

M, 3

6% re

tro-

rect

us, 4

% o

nlay

80%

≥24

35%

28%

1%66

%0%

28%

Krpa

ta21

37*

95%

Ope

n/en

do A

CS

or P

CS

78%

non

-cro

ss-li

nked

por

cine

der

mis

(9

6% S

trat

tice,

4%

Xen

mat

rix)

22%

non

-cro

ss-li

nked

hum

an d

erm

is (A

llode

rm)

53%

retro

-rec

tus,

42

% IP

OM

, 6%

‘s

andw

iche

d’

89%

20 (3

-73)

43%

na3%

nana

32%

Rose

n912

870

%O

pen/

endo

ACS

or

PCS

83%

non

-cro

ss-li

nked

por

cine

der

mis

(9

6% S

trat

tice

, 4%

Xen

mat

rix)

13%

non

-cro

ss-li

nked

hum

an d

erm

is (A

llode

rm)

3% n

on-c

ross

-link

ed p

orci

ne in

test

inal

(B

iode

sign

)3%

‘Bio

A’

32%

IPO

M, 6

6%

retro

-rec

tus,

2%

on

lay+

unde

rlay,

1%

onla

y

94%

21.7

(±15

.9,

1-73

.8)

nana

na48

%0%

31%

CS =

com

pone

nt s

epar

atio

n, S

D =

sta

ndar

d de

viat

ion,

EF

= en

teric

fist

ula,

SSO

= s

urgi

cal s

ite o

ccur

renc

e, H

R =h

erni

a re

curr

ence

, ACS

= a

nter

ior c

ompo

nent

se

para

tion,

PCS

= p

oste

rior c

ompo

nent

sep

arat

ion,

end

o =

endo

scop

ic. †

Man

ufac

ture

r det

ails

are

giv

en in

App

endi

x 2,

‡Fo

r all

incl

uded

pat

ient

s in

this

stu

dy,

*one

pat

ient

did

not

und

ergo

bio

logi

c m

esh

repa

ir


5


119

Tabl

e 3.

Sur

gica

l cha

ract

eris

tics

and

outc

omes

of s

tudi

es d

escr

ibin

g no

nabs

orba

ble

synt

hetic

mes

h re

pair

in a

ll pa

tient

s

Refe

renc

eN

o. o

f re

pairs

CS

%Ty

pe o

f CS

Type

of m

esh

%M

esh

loca

tion

%Fa

scia

l cl

osur

e %

Mea

n fo

llow

-up

in m

onth

s (±

SD o

r ra

nge)

Wou

nd

infe

ctio

n%

Sero

ma

%

EF %

SSO %

Mes

h re

mov

al†

%

HR %

Clea

n-co

ntam

inat

ed o

r pot

entia

lly c

onta

min

ated

Br

ahm

bhat

t2927

na-

55%

pol

ypro

pyle

ne33

% p

olye

thyl

ene

15%

PTF

E

100%

IPO

Mna

Mdn

20

(7-1

33)

19%

22%

na44

%na

19%

Chan

4145

na-

62%

coa

ted

poly

prop

ylen

e38

% e

xpan

ded

PTFE

nana

Mdn

13

4%na

nana

0%0%

El-G

azza

z4640

na-

100%

hea

vyw

eigh

t pol

ypro

pyle

ne10

0% o

nlay

naM

dn 3

(IQ

R 1.

8-4.

6)

year

s23

%na

nana

3%40

%

Ion31

56na

-10

0% p

olyp

ropy

lene

or c

ompo

site

ex

pand

ed P

TFE

89%

retro

-rec

tus,

11

% in

lay

89%

na7%

nana

nana

na

Prav

een42

36na

-10

0% c

ompo

site

ligh

twei

ght

poly

prop

ylen

e 10

0% IP

OM

92%

13.1

(2-3

1)na

nana

na0%

0%

Cont

amin

ated

or i

nfec

ted

Carb

onel

l1710

049

%PC

S or

AC

S10

0% li

ghtw

eigh

t pol

ypro

pyle

ne94

% re

tro-r

ectu

s,

5% IP

OM

, 1%

onl

ay91

%10

.8 (±

9.9)

11%

5%1%

31%

4%7%

CS =

com

pone

nt s

epar

atio

n, E

F =

ente

ric fi

stul

a, S

SO =

sur

gica

l site

occ

urre

nce,

HR

=her

nia

recu

rren

ce, A

CS =

ant

erio

r com

pone

nt s

epar

atio

n, P

CS =

pos

terio

r co

mpo

nent

sep

arat

ion,

end

o =

endo

scop

ic

R1R2R3R4R5R6R7R8R9


CHAPTER 5

120

The remaining 11 studies described various types of mesh or techniques and were not included in meta-analyses (Table 4). In one study only absorbable synthetic meshes were used47. Seven studies described both mesh repair and primary repair, or both synthetic and biologic mesh repair19,22,28,35,39,44,45. One study described abdominal wall repair with use of an autogenous pedicled demucosalized small intestinal sheet43. In one study type of mesh was unknown whereas another study only reported on the method of repair for all patients, not separately for patients fulfilling the inclusion criteria of the present review18,33.

Of all 30 studies including patients of whom all or a subset underwent mesh repair, 24 gave information on mesh location. The majority (13 studies9,17,21,27,28,31,32,34,37,38,40,44,47) reported multiple mesh locations whereas 11 described on a specific method of mesh placement; IPOM20,23,29,36,42 (5), inlay19,43 (2), onlay46 (1) or underlay (either IPOM or retro-rectus)24,25,30 (3).

Thirteen studies gave no information on whether or not primary fascial closure was achieved18,20,22,26,28-30,33,35,37,41,45,46. The other 19 studies reported on primary closure rates ranging from 0 to 95%, with 13 studies describing a rate of bridged repairs (no primary closure) of less than 25%9,17,21,23-25,27,31,39,40,42,44,47.


5


121

Tabl

e 4.

Sur

gica

l cha

ract

eris

tics

and

outc

omes

of s

tudi

es d

escr

ibin

g va

rious

type

s of

mes

h te

chni

ques

Refe

renc

eN

o. o

f re

pairs

CS

%Ty

pe o

f CS

Mes

h us

ed %

Type

of m

esh

%†

Mes

h lo

catio

n%

†Fa

scia

l cl

osur

e %

Mea

n fo

llow

-up

in m

onth

s (±

SD

or ra

nge)

Wou

nd

infe

ctio

n%

Sero

ma

%

EF %

SSO %

Mes

h re

mov

al†

%

HR %

Alto

m28

46na

-33

%53

% p

olyp

ropy

lene

40

% a

bsor

babl

e7%

exp

ande

d PT

FE

73%

‘ove

rlay/

inte

rlay’

, 27

% u

nder

lay

naM

dn 6

9.3

(19.

1-98

.3)

13%

na4%

na20

%35

%

Choi

1839

01na

-10

0%-

-na

≥ 30

day

s10

%na

nana

nana

Conn

olly

1963

na-

46%

48%

abs

orba

ble

41%

cro

ss-li

nked

por

cine

der

mis

(P

erm

acol

)10

% c

ompo

site

ligh

twei

ght

poly

prop

ylen

e

100%

inla

y54

%M

dn 2

9 (1

6-84

)27

%na

22%

nana

29%

El-G

azza

z4525

0%na

100%

40%

por

cine

der

mal

(unk

now

n ty

pe)

32%

pol

ypro

pyle

ne28

% P

TFE

nana

32.9

(±38

.2)

44%

nana

na8%

36%

Le22

171

na-

44%

91%

bio

logi

c9%

syn

thet

icna

na≥1

232

%10

%8%

18%

na11

%

Liu43

41na

-10

0%10

0% ‘a

utog

enou

s pe

dicl

ed

dem

ucos

aliz

ed s

mal

l int

estin

al s

heet

‘10

0% in

lay

0%≥2

40%

na0%

nana

0%

Slat

er44

3987

%O

pen

ACS

33%

100%

ligh

twei

ght p

olyp

ropy

lene

77%

retro

-rec

tus,

15%

IP

OM

, 8%

unk

now

n90

%62

.7 (3

6-13

0)18

%5%

5%46

%3%

31%

Van

Gef

fen39

2610

0%O

pen

ACS

15%

100%

pol

yest

erna

85%

27 (1

3-78

)19

%12

%12

%na

na8%

Win

d4732

100%

Ope

n AC

S56

%10

0% a

bsor

babl

e 72

% o

nlay

, 28%

‘b

ridgi

ng’

84%

20 (3

-54)

22%

na13

%na

na25

%

Won

3349

na-

nana

-na

90 d

ays

16%

10%

na37

%na

2%Xo

uraf

as35

51na

-10

0%75

% p

olyp

ropy

lene

8% n

on-c

ross

-link

ed h

uman

der

mis

(A

llode

rm)

8% a

bsor

babl

e 2%

non

-cro

ss-li

nked

por

cine

inte

stin

al

(Sur

gisi

s)2%

PTF

E2%

pol

yest

er2%

xer

ophy

llum

2% u

nkno

wn

nana

21 (m

dn 7

)22

%4%

14%

na14

%22

%

156

na-

0%-

nana

23 (m

dn 7

)5%

1%6%

nana

24%

CS =

com

pone

nt s

epar

atio

n, E

F =

ente

ric fi

stul

a, S

SO =

sur

gica

l site

occ

urre

nce,

HR

=her

nia

recu

rren

ce, A

CS =

ant

erio

r com

pone

nt s

epar

atio

n, P

CS =

pos

terio

r co

mpo

nent

sep

arat

ion,

end

o =

endo

scop

ic. †

With

in a

ll m

esh

R1R2R3R4R5R6R7R8R9


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122

Surgical site complication ratesThe pooled rates of various outcomes after repair of clean-contaminated or potentially contaminated hernias are given in Figure 2. Ten studies on biologic mesh described repair of predominantly clean-contaminated or potentially contaminated hernias, combining for a total of 807 patients20,23-26,32,36-38,40. Pooled wound infection rate was 21% (95% CI 11 to 32, I2=91%). Seroma and fistula formation rates were 8% (95% CI 5 to 11, I2=34 %) and 2% (95% CI 0 to 7, I2=87%), respectively. Overall surgical site complication rate was 50% (95% CI 30 to 70, I2=91%) and mesh removal rate was 1% (95% CI 0 to 6, I2=80%). Five studies comprising 204 patients described the use of a non-absorbable synthetic mesh for the repair of potentially contaminated defects29,31,41,42,46. The pooled wound infection rate was 12% (95% CI 4 to 22, I2=65%). Seroma rate was 7% (95% CI 0 to 41, I2=92%). No studies reported on enteric fistula rate, whereas only one reported an overall surgical site complication rate of 44%29. Removal rate of synthetic mesh was 0% (95% CI 0 to 3, I2=0%).

123

Figure 2 Repair of clean‐contaminated or potentially contaminated hernias with biologic or

synthetic mesh

Figure 3 Repair of contaminated or infected hernias with biologic mesh

Figure 2 Repair of clean-contaminated or potentially contaminated hernias with biologic or synthetic mesh

Five studies on six separate patients series described the use of a biologic mesh for the repair of contaminated or infected abdominal wall defects (Figure 3)9,21,27,30,34. Pooled wound infection rate was 38% (95% CI 29 to 47, I2=0%). One study reported on seroma rate (28%)27. Enterocutaneous fistula rate was 2% (95% CI 0 to 5, I2=0%). Pooled overall surgical site complication rate was 48% (95% CI 34 to 62, I2=89%). Pooled mesh removal rate was 5% (95% CI 0 to 13, I2=90%), with the two studies on StratticeTM reporting a removal rate of zero per cent9,27. Only one study reported on the use of non-absorbable synthetic mesh (lightweight polypropylene) for predominantly contaminated hernia repair17. This study included 100 patients and described a wound infection and overall surgical site complication rate of 11 and 31%, respectively. Fistulas were seen in 1% of patients and 4% patients needed to undergo mesh removal.


5


123

As only one study selectively described the use of a cross-linked biologic mesh (in a subset of patients)34, comparisons of cross-linked versus non-cross-linked biologic meshes were deemed not appropriate.

123

Figure 2 Repair of clean‐contaminated or potentially contaminated hernias with biologic or

synthetic mesh



Hernia recurrence ratesPooled rates of hernia recurrence for studies with a minimal follow-up of one year and with a reported primary fascial closure rate of more than 75% are depicted in Fig. 2.

Five studies on biologic mesh repair of potentially contaminated defects combined for a hernia recurrence rate of 9% (95% CI 4 to 15, I2=66%), with mean follow-up ranging from 15 to 43 months23-26,40. Four studies enabled pooling of hernia recurrence rates after synthetic mesh repair of potentially contaminated defects29,41,42,46. The studies had a mean follow-up ranging from 13 to 20 months and showed a pooled recurrence rate of 9% (95% CI 0 to 34, I2=93%).

Four studies on biologic mesh use for contaminated defects met the criteria for analysis of recurrence rates, with approximately 75% of patients undergoing StratticeTM mesh repair9,21,27,30. Mean follow-up ranged from 14 months to more than 24 months. The pooled hernia recurrence rate was 30% (95% CI 24 to 35, I2=0%) (Fig. 3). The one study on synthetic mesh use for contaminated hernia repair had a mean follow-up of mere 10.8 months with a reported hernia recurrence rate of 7%17.

Bridged repair are by definition associated with higher recurrence rates. No studies reported on synthetic mesh repair of large potentially contaminated or contaminated defects needing bridged repair. Regarding studies on biologic mesh repair of potentially contaminated defects, three studies included bridged repairs, with primary fascial closure rates ranging from 0 to 53, and combined for a hernia recurrence rate of 24% (95% CI 18 to 31, I2=0%)32,36,38. One study described two subgroups of patients undergoing biologic repair of contaminated defects with primary fascial closure rates of 43 and 26%34. Hernia recurrence rates were 32 and 47%, respectively.

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124

DISCUSSION

This study provides an overview of published literature on the repair of (potentially) contaminated abdominal wall defects. High quality data is lacking, as only one prospective observational study was included. Available low-level evidence showed no benefit of biologic over synthetic mesh for repair of potentially contaminated hernias (9% vs. 9% hernia recurrence rate), but as head-to-head comparisons were lacking all studies were likely influenced by selection bias. This might also explain why considerable higher wound infection rates were found for biologic repair compared to synthetic repair. Literature on contaminated or infected defects is dominated by studies on biologic mesh use; only one study reported on the repair of predominantly contaminated hernias with use of a lightweight synthetic mesh. Therefore, for contaminated cases in this systematic review, a reliable estimate only could be made for biologic repair. Pooled hernia recurrence rate after biologic repair of contaminated defects was 30%. The absence of comparative data hinders evaluating whether (lightweight) synthetic mesh offers a safe and durable alternative for the repair of contaminated defects.

Several previous attempts have been made to systematically summarize the available evidence on ventral hernia repair using biologic meshes48-50. However, these reviews focused on the material being used and included studies describing patients with hernias classified as clean. As previously stressed, the efficacy of techniques and materials should always be evaluated with a thorough understanding of the specific characteristics of each hernia15. To our knowledge, there is only one previous systematic review on potentially contaminated and contaminated hernia repair, although evaluating available literature until April 201351. Besides the fact that of the 32 included studies in the present review 11 were published in 2014 and 2015, several other explanations for the found differences exist. The review by Lee et al. included multiple studies on ventral hernia prophylaxis and stoma site closure. Smaller series were included, presumably reflecting less methodologically robust studies. Furthermore, they did not take into account primary fascial closure rates when evaluating hernia recurrence rates.

Numerous questions could not be answered by this review. Ideally, different types of biologic meshes are evaluated separately, as not all behave equally. Cross-linked biologic meshes have questionable infection susceptibility, particularly in contaminated wounds52,53. This is perhaps underlined by the fact that the vast majority of studies on biologic mesh repair included in present review described the use of a non-cross-linked mesh. One retrospective study compared a cross-linked porcine derived mesh with a non-cross-linked human derived mesh and showed higher surgical site complication rate following cross-linked mesh repair, although the hernia recurrence rate was lower34. Given the limited amount of available studies, no comparison between different types of biologic meshes was made. Comparatively, a sensitivity


5


125

analysis of different types of synthetic material was not made. Light-weight synthetic meshes have shown potential benefits over heavy-weight materials, making them more suitable for repair of contaminated defects. The only included study in this review on the use of synthetic material for contaminated defect repair described the results of a light-weight mesh with encouraging outcomes17. The use of light-weight synthetic mesh for hernia prophylaxis after clean-contaminated surgery emphasizes the potential of this material54. However, the durability of light-weight meshes has also been questioned, compared to both synthetic and biologic material26,55. The impact of mesh position was also not evaluated, although it is known to influence outcome56. Most included studies placed the mesh in underlay position, either intraperitoneally or in a retro-rectus position. However, lower hernia recurrence rates following biologic mesh placed in a retro-rectus position have been reported9,57.

Several limitations of this review need to be addressed. Most importantly, the review is limited by the low quality of included evidence. Only one prospective observational study was included while the majority of reports were retrospective case series. All of the included studies were at high risk of bias. Furthermore, there was substantial heterogeneity among the included studies regarding patient demographics and surgical techniques such as the use of component separation. Moreover, the I2 statistic also indicated substantial heterogeneity for most analyses. Some analyses showed low statistical heterogeneity. However, the quantification of heterogeneity using I2 is only part of the investigation of the variability between studies. Clinical and methodological differences between studies in the specific analyses with low statistical heterogeneity are likely equally present as in all other analyses. Although commonly used classification systems for the degree of contamination were reported, the validity of these systems has been questioned13,26. The subdivision of studies included in the meta-analysis forced some generalisations. As previously mentioned, no differences were made between different types of biologic and synthetic meshes. Moreover, for the categorisation based on contamination, the degree of contamination of the majority of described hernias determined whether a study was labelled as ‘potentially contaminated’ or ‘contaminated’. This oversimplification may have caused some of the heterogeneity among studies within a category of contamination.

Given the aforementioned limitations, the results of this review should be interpreted with caution since head-to-head studies of biologic versus synthetic meshes were lacking. Without head-to-head comparison differences in patient characteristics and likely selection bias in single-type intervention studies make definite conclusions hazardous. Initial higher costs of biologic material warrant selective usage, although indirect evidence suggests that downstream costs might be lower58. Evidence on contaminated abdominal wall hernia repair is limited, with the majority of studies describing the use of biologic material.

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126

Finally, this review highlights the need for consensus on the role of biologic mesh in abdominal wall. Reports on repairs in clean and clean-contaminated hernias have muddled this debate as an indication for biologic material in clean hernias is lacking. Although randomised trials are perhaps difficult to conduct, prospective studies or large registries are needed, using uniform definitions and criteria to describe patients, hernia and surgical characteristics.


5


127

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