JAMA Surgery

JAMA Surg. 2019 Feb; 154(2): 109–115. PMCID: PMC6439658

Published online 2018 Nov 21. PMID: 30476940
doi: 10.1001/jamasurg.2018.4221: 10.1001/jamasurg.2018.4221

Effectiveness of Prophylactic Intraperitoneal Mesh Implantation for

Prevention of Incisional Hernia in Patients Undergoing Open Abdominal
Surgery
A Randomized Clinical Trial
Andreas Kohler, MD,1 Joel L. Lavanchy, MD,1 Ursina Lenoir, MD,1 Anita Kurmann, MD,1 Daniel Candinas, MD,1 and
Guido Beldi, MD 1
1Department of Visceral Surgery and Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland

Corresponding author.
Article Information

Accepted for Publication: July 23, 2018.

Corresponding Author: Guido Beldi, MD, Department of Visceral Surgery and Medicine, Inselspital, Bern University Hospital,
University of Bern, 3010 Bern, Switzerland (guido.beldi@insel.ch).

Published Online: November 21, 2018. doi:10.1001/jamasurg.2018.4221

Author Contributions: Drs Kohler and Beldi had full access to all the data in the study and take responsibility for the integrity
of the data and the accuracy of the data analysis.

Concept and design: Kurmann, Candinas, Beldi.

Acquisition, analysis, or interpretation of data: Kohler, Lavanchy, Lenoir, Beldi.

Drafting of the manuscript: Kohler, Beldi.

Critical revision of the manuscript for important intellectual content: Kohler, Lavanchy, Lenoir, Candinas, Beldi.

Statistical analysis: Kohler, Beldi.

Obtained funding: Kurmann, Beldi.

Administrative, technical, or material support: Kohler, Beldi.

Supervision: Candinas, Beldi.

Conflict of Interest Disclosures: None reported.

Funding/Support: The company Laubscher & Co Ltd, Hölstein, Switzerland, provided funding for the study nurse. Laubscher
& Co is a distributor of medical products and other meshes for hernia repair.

Role of the Funder/Sponsor: The funding source had no role in the design and conduct of the study; collection,
management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to
submit the manuscript for publication.

Meeting Presentation: Presented in part at the annual meeting of the German Society of Surgery; March 24, 2017; Munich,
Germany.

Additional Information: The initiator of this study, Anita Kurmann, MD, died on August 7, 2015.

Received 2018 Jan 17; Accepted 2018 Jul 23.

Copyright 2018 American Medical Association. All Rights Reserved.

Key Points
Question
Is prophylactic intraperitoneal mesh implantation effective in preventing incisional hernia after elective open abdominal
surgery?

Finding
An open-label randomized clinical trial was performed in 169 patients undergoing elective open abdominal surgery. The
trial found that prophylactic intraperitoneal mesh implantation reduces the incidence of incisional hernia but with increased
early postoperative pain and prolonged wound healing of surgical site infection.

Meaning
Incisional hernia is a frequent complication after open abdominal surgery; intraperitoneal mesh implantation is a simple and
effective measure to prevent this complication.

Abstract

Importance
Incisional hernia is a frequent complication after open abdominal surgery. Prophylactic mesh implantation in the onlay or
sublay position requires dissection of the abdominal wall, potentially leading to wound-associated complications.

Objective
To compare the incidence of incisional hernia among patients after prophylactic intraperitoneal mesh implantation with that
among patients after standard abdominal closure.

Design, Setting, and Participants

An open-label randomized clinical trial was performed in 169 patients undergoing elective open abdominal surgery from
January 1, 2011, to February 29, 2014. Follow-up examinations were performed 1 year and 3 years after surgery. The
study was conducted at Bern University Hospital, Bern, Switzerland, a referral center that offers the whole spectrum of
abdominal surgical interventions. Patients with 2 or more of the following risk factors were included: overweight or
obesity, diagnosis of neoplastic disease, male sex, or history of previous laparotomy. Patients were randomly assigned to
prophylactic intraperitoneal mesh implantation or standard abdominal closure. Data were analyzed in August 2017.

Interventions
Intraperitoneal implantation of a polypropylene-polyvinylidene fluoride mesh with circumferential fixation.

Main Outcomes and Measures

The primary end point was the incidence of incisional hernia 3 years after surgery. Secondary end points included mesh-
related complications.

Results
After the exclusion of 19 patients, 150 patients (81 in the control group and 69 in the mesh group; mean [SD] age, 64.2
[11.1] years; 102 [68.0%] male) were studied. The cumulative incidence of incisional hernia was significantly lower in the
mesh group compared with the control group (5 of 69 [7.2%] vs 15 of 81 [18.5%], log-rank test P = .03). Abdominal
pain was observed in significantly more patients in the mesh group compared with the control group at 6 weeks (34 of 52
[65%] vs 26 of 59 [44%], P = .04) but not at 12 and 36 months postoperatively. No difference in surgical site infections
was observed, but time to complete wound healing of surgical site infection was significantly longer in patients with mesh
implantation (median [interquartile range], 8 [6-24] weeks compared with 5 [1-9] weeks; P = .03). Trunk extension was
significantly decreased after mesh implantation compared with the control group (mean [SD], 1.73 [0.97] cm vs 2.40
[1.23] cm, P = .009).

Conclusions and Relevance

In patients at elevated risk for incisional hernia, prophylactic intraperitoneal mesh implantation reduces the incidence of
hernia formation but with increased early postoperative pain and prolonged wound healing of surgical site infection.

Trial Registration
ClinicalTrials.gov Identifier: NCT01203553

Introduction
Under current guidelines, a running, slowly absorbable suture is recommended for the closure of the abdominal wall after
laparotomy.1 However, this technique is associated with a considerable incidence of incisional hernia. Despite a wide
variability of reported incidence, relevant studies2,3,4,5 indicate a frequency between 10% and 30% on long-term follow-
up. Novel techniques, including the use of small bites, may reduce the incidence of incisional hernia after midline
laparotomies.6,7 However, despite technical modifications, the rate of incisional hernia remains clinically significant, with
an incidence of up to 13%6,7; therefore, it is important to reduce incisional hernia in patients undergoing open abdominal
surgery.

The benefit of prophylactic mesh implantation in reducing the incidence of incisional hernia after laparotomy has been
reported in previous studies.8,9,10 Onlay or sublay mesh position was investigated in most studies,10,11,12,13 which
requires additional dissection of the abdominal wall, is time consuming and can therefore be a hindrance in routine
prophylactic mesh implantation. Furthermore, an elevated rate of seroma formation was reported after onlay and sublay
mesh implantation, potentially because of the increased wound surface area.8,14 Intraperitoneal placement of modern
dual-layered meshes could potentially overcome these limitations by reducing the time required for mesh implantation and
minimizing dissection of the abdominal wall.15,16 Therefore, the efficacy of prophylactic intraperitoneal mesh implantation
for the prevention of incisional hernia after laparotomy was tested in a randomized clinical trial.

To maximize the benefit-risk ratio, prophylactic mesh implantation would ideally be performed in patients at elevated risk
for hernia development. Previous studies17,18 explored the outcome of prophylactic mesh implantation after specific
procedures with elevated risk for incisional hernia, such as bariatric or abdominal vascular surgery. The current study
explores a population undergoing general abdominal surgery, including hepatobiliary, pancreatic, and upper and lower
gastrointestinal tract surgery. A population at risk was defined by patient-related risk factors that can be recognized
preoperatively. Such stratification allows identification of patients at elevated risk for incisional hernia development, who
potentially benefit the most from mesh implantation. Numerous preoperative recognizable risk factors for incisional hernia
have been described in the literature, including overweight or obesity, low hemoglobin level, uremia, male sex, old age,
smoking, previous laparotomy, and diagnosis of neoplastic disease.2,3,4,19,20,21,22,23,24,25 To ensure practicability in
daily clinical routine, only strong risk factors were included for stratification that are dichotomous, occur frequently, and
are easy to identify. Thus, the following risk factors were used for patient stratification: overweight or obesity, diagnosis of
neoplastic disease, male sex, and history of laparotomy. Patients with at least 2 of these risk factors were included. With
this study design, we tested the hypothesis that primary mesh implantation in an intraperitoneal position reduces the risk of
incisional hernia in a population at risk.

Methods

Trial Design
An open-label randomized clinical trial with 1:1 randomization in 2 parallel groups was performed at the Department of
Visceral Surgery and Medicine in the University Hospital of Bern, Bern, Switzerland. The trial protocol can be found in
Supplement 1. The study was conducted under the working title ProphMesh. The study, including the increase of sample
size, was approved by the Ethical Committee of the Canton of Bern.

Participants
Patients seen at the visceral surgical outpatient department who were scheduled for open abdominal surgery from January
1, 2011, to February 29, 2014, were assessed for eligibility. Inclusion criteria were age older than 18 years, elective
operation, and the presence of at least 2 of the following risk factors for incisional hernia development: body mass index
above 25 (calculated as weight in kilograms divided by height in meters squared), diagnosis of neoplastic disease, male
sex, and history of laparotomy. Exclusion criteria were previous intraperitoneal mesh placement, previous incisional hernia,
emergency procedures, and patients with inflammatory bowel disease. All patients had to sign informed consent forms
before inclusion in the study. Data were deidentified with a key according to Swiss regulations. Data were analyzed in
August 2017.

Interventions

The scheduled operation was performed as planned. In the control group, the abdominal wall was closed according to the
institutional standard operating procedure, using a slowly absorbable running suture (USP 1 PDS II loop, Ethicon,
Johnson & Johnson). The distance of the stitches to the fascial border was 1 cm, and the distance between stitches was
also 1 cm. In the intervention group, a mesh was implanted before closure of the abdominal wall in a standardized fashion.
A double-layered polypropylene-polyvinylidene fluoride mesh (Dynamesh-IPOM, FEG Textiltechnik) was tailored to
overlap lateral and cranial-caudal borders by at least 5 cm. The mesh was placed intraperitoneally and fixed to the
abdominal wall using single stitches with polypropylene sutures (USP 2-0 Prolene; Ethicon) in all 4 corners. After the
initial fixation, the borders of the mesh were fixed to the abdominal wall circumferentially using running polypropylene
suture to prevent any intestinal structures to herniate onto the mesh. Afterward, the abdominal wall was closed as
described in the control group. In both groups, the subcutaneous tissue was not adapted separately; the skin was closed
using interrupted stitches with polypropylene sutures (USP 3-0 Prolene; Ethicon) or skin staples, according to the
surgeon’s choice.

Outcomes
Data collection was performed at the outpatient department preoperatively and at 6 weeks, 1 year, and 3 years
postoperatively. Patients were interviewed according to the respective questionnaires, and a clinical examination was
performed by observers not otherwise involved in the planning or conduct of the study.

The primary outcome of the study was the incidence of an incisional hernia as defined by the European Hernia Society: an
abdominal wall gap with or without bulge in the area of the postoperative scar palpable by clinical examination.26 The
patients were seen for follow-up visits at the outpatient department and examined by a qualified physician with at least 2
years of surgical training. Imaging studies were performed if there was uncertainty about the diagnosis. Mean follow-up
time was 16.9 months in the control group and 18.7 months in the intervention group.

Secondary outcomes were the occurrence of postoperative complications; hematoma, intestinal paralysis, and in-hospital
mortality were reported until 30 days postoperatively. Fistula formation, small-bowel obstruction, and surgical site
infection (SSI) were reported for the whole follow-up period of 3 years.27 Pain levels were assessed during the hospital
stay and at 6 weeks, 1 year, and 3 years postoperatively. During follow-up consultations, patients were asked whether
they still felt pain in the abdominal region and to rate the intensity of pain on a visual analog scale (VAS) from 0 to 10, with
0 indicating no pain and 10 indicating worst imaginable pain. Furthermore, they were asked to report whether they
perceived pain at least once a day. Range of motion for trunk flexion and extension was assessed before and after surgery
by measuring finger-to-floor distance and umbilicus-xiphoid distance in upright position and in maximal trunk retroflection.

Sample Size
On the basis of existing studies,2,4,28 we expected 25% of control patients from our at-risk population to develop an
incisional hernia during the 3 years. In patients with an implanted mesh, an incidence of approximately 5% was expected,
as observed in patients undergoing similar operations in our department before the initiation of the study.29

We calculated that a total of 150 patients needed to be included in the study to demonstrate the difference, presuming a
2-sided level of significance at 5% and a power of 80%. This number also allowed for a loss to follow-up of up to 20% in
the patient sample. Because of the unexpectedly high number of patients (n = 19) excluded from the study during surgery,
the aimed sample size was increased from 150 to 170 to ensure that 150 patients were treated according to
randomization. An amendment was written and approved by the local ethics committee on February 12, 2013.

Randomization
Randomization was performed in permuted blocks of 30 patients, using the online tool randomization.com by an external
study nurse. Sealed and numbered envelopes that contained the allocated group were prepared and opened during
surgery before abdominal wall closure.

Statistical Analysis
Continuous variables were described using means (SDs). For categorical values, numbers (percentages) were calculated.
Differences between groups were compared using the 2-tailed, unpaired t test or Mann-Whitney test for continuous
variables and the Fisher exact test for categorical variables. Statistical significance was defined as 2-sided P < .05. In this
intent-to-treat analysis, patients randomized to the mesh group were analyzed in the mesh group even if the mesh was
explanted during follow-up. Patients in the control group were analyzed in the control group even if they underwent
additional surgery with eventual prophylactic mesh implantation. Analysis was performed using SPSS statistical software,
version 21 (IBM Corp) and Prism software, version 6 (GraphPad). A Kaplan-Meier curve of the occurrence of incisional
hernias stratified by treatment group was plotted, and a log-rank test was used to compare the hernia incidence between
the groups.

Results
Demographics
A total of 169 patients were randomized into a control group (n = 86) or a mesh group (n = 83). Nineteen patients were
excluded from the study during surgery because new information that conflicted with the inclusion or exclusion criteria
became evident (existing incisional hernia, finding of an implanted mesh), second-look surgery became necessary, or
surgery revealed a terminal stage of disease (peritoneal carcinomatosis) with the surgeon disagreeing with mesh
implantation. Therefore, 81 patients in the control group and 69 in the mesh group were studied (mean [SD] age, 64.2
[11.1] years; 102 [68.0%] male). Details are shown in Figure 1. Baseline data were similar between groups (Table 1).

Primary Outcome
The incidence of incisional hernia 3 years after surgery was significantly higher in the control group vs the mesh group (15
of 81 [18.5%] vs 5 of 69 [7.2%]). Comparison of the cumulative hazard curves revealed a statistically significant
difference between the groups (log-rank test P = .03) (Figure 2). In both groups, most hernias occurred during the first
year after surgery. Follow-up at 1 year resulted in incisional hernia in 13 of 51 individuals (25.5%) in the control group vs
3 of 45 individuals (6.7%) in the mesh group. At the 3-year follow-up visit, 7 of the 30 control group patients (23.3%)
presented with a hernia compared with 3 of 30 mesh group patients (10.0%).

Reasons for hernia occurrence in the mesh group were mesh removal in one patient and an additional laparotomy with
abdominal wall closure using resorbable suture material in another patient. For the other patients with hernia occurence in
the intervention group, the reason for failure of the implanted mesh remains unclear.

Secondary Outcomes
There was no statistically significant difference between the control and intervention groups concerning occurrence of
hematoma (1.2% vs 1.4%; P > .99), intestinal paralysis (4.9% vs 4.4%; P > .99), length of hospital stay (13.5 vs 13
days; P = .46), or in-hospital mortality (3.7% vs 1.4%; P = .62) (Table 2). The incidence of small-bowel obstruction was
similar between the groups during the entire observation time (Table 2). No enterocutaneous fistula was observed in either
group during follow-up. The incidence of SSI was not statistically different between the control (18 of 69 [26.1%]) and
mesh (11 of 61 [18.0%]) groups (P = .30). However, in patients with SSI, completion of wound healing took longer in
the mesh group compared with the control group (median [interquartile range], 8 [6-24] weeks compared with 5 [1-9]
weeks; P = .03). Surgical wound revisions were more frequent in the mesh group (Table 2).

Pain was similar between the groups during hospital stay (Table 3). At 6 weeks, significantly more patients in the mesh
group reported postoperative pain compared with patients in the control group (34 of 52 [65.4%] vs 26 of 59 [44.1%];
effect size, 21.3%; 95% CI, 4%-41%; P = .04). Pain intensity was higher in the mesh group compared with the control
group at 6 weeks (mean VAS score, 1.61 vs 0.83; VAS score difference, 0.78; 95% CI, 0.10-1.46; P = .02). At 1 and
3 years after surgery, no difference in pain perception was observed between the groups (Table 3).

Trunk extension, assessed by elongation of umbilicus-xiphoid distance, was significantly reduced in the mesh group
compared with the control group at 12 months (2.40 vs 1.73 cm; effect size, 0.675; 95% CI, 0.18-1.1; P = .009) but not
at 36 months after surgery. Trunk flexion, as assessed by finger-to-floor distance, was not significantly different between
the groups at all follow-up time points (eFigure in Supplement 2).

Discussion
Our findings reveal that prophylactic intraperitoneal mesh implantation significantly reduces the incidence of incisional
hernia 3 years after laparotomy compared with standard abdominal closure in a high-risk population. This study confirms
previous reports8,9,10,29 that found similar effects of prophylactic mesh implantation. The current study has 2 main
differences to most previous reports.8,9 First, the study population represents patients with elevated risk profile for hernia
development that are patient and not procedure related. Second, a double-layered mesh was implanted in an
intraperitoneal position, whereas previous studies10,11,12 explored mesh implantation in onlay or sublay positions.

The incidence of incisional hernia in the control group was above average for an elective surgical population but in the
same range as reported in current studies9,10,11,12 on prophylactic mesh implantation in at-risk patient collectives. This
finding indicates that the simple scoring system used allows identification of a population at elevated risk for hernia
development based on personal risk factors that can be recognized preoperatively.

The incidence of incisional hernia was significantly lower in the mesh group, showing that intraperitoneal mesh implantation
is effective for prevention of hernia development. Among the 5 hernias that developed in the mesh group, 2 occurred
because of technical aspects during secondary surgery, including mesh removal and mesh adaptation using resorbable
suture material.
In our study, the calculated number needed to treat is 8.9; accordingly, 9 patients have to undergo prophylactic mesh
implantation to prevent 1 incisional hernia. This number is in line with the current literature that shows a number needed to
treat between 5 and 10 for prophylactic mesh implantation in patients undergoing surgical procedures with an increased
risk of hernia formation.8 Because not every incisional hernia needs surgical repair, the number needed to treat to prevent
1 hernia repair is likely to be higher. We believe that risk assessment for incisional hernia should be performed to keep the
number needed to treat low and to reduce unnecessary mesh implantations.

The recently published results of the Small Bites Versus Large Bites for Closure of Abdominal Midline Incisions
(STITCH) trial revealed a decrease of incisional hernias after 1 year of follow-up with a small-bite technique.6 Because of
the focus on a high-risk population in the current study, a direct comparison of hernia rates is not accurate. Prophylactic
mesh implantation vs the small-bite technique should be compared directly in a future study.

Implantation of a mesh in an intraperitoneal position was not associated with an increase in the incidence of SSI.
However, patients who developed SSI experienced delayed wound healing (Table 2). Such delayed wound healing is
most likely the consequence of secondary infection of the prosthesis. The median healing time in the mesh group was 2
months; 5 of 12 patients had a chronic wound, defined as a healing time of more than 3 months.30 The fact that more than
half of patients with mesh infection healed without mesh removal may be because the mesh was based on polypropylene
and not on polyester that is more prone to chronic infection.31,32,33 Small-bowel obstruction, which potentially may
occur after mesh implantation, was not significantly different between the 2 groups at long-term follow-up. No fistula was
detected in either group, which is in line with the literature.34,35,36

Chronic postoperative pain is a potential challenge in hernia surgery and after prophylactic mesh placement. Prevalence
and intensity of pain 6 weeks postoperatively were significantly higher in the mesh group compared with the control
group. This elevated pain might be caused by tension through mesh fixation sutures in the abdominal wall or by
inflammatory reaction to the implanted mesh. However, there was no difference in pain at long-term follow-up.

A preventive measure should be simple and fast in its application, which is where we see the advantage of the
intraperitoneal onlay mesh technique. The mesh can be implanted without creating an additional wound surface area
because no further dissection of the abdominal wall is needed. In the present study, clinically relevant long-term mesh-
associated complications, such as erosion and formation of adhesions, were not observed.

Limitations
Limitations of the study include the high rate of unavailability for follow-up, the exclusion of patients during surgery, and
lack of quality-of-life assessment. Because this study investigated a high-risk population with a significant fraction of
patients with malignant disease, mortality was observed in some patients before reaching the end point. In the power
calculation, a loss to follow-up of 20% was initially calculated. Therefore, the actual loss of patients was underestimated,
mainly because of mortality and withdrawal from study participation. However, there was no difference in loss to follow-
up between the 2 groups. Mesh implantation needed to be documented in the operation report to inform medical
personnel responsible for aftercare and to ensure patient safety. Therefore, masking of the patient and the assessor during
follow-up visits was not possible. To minimize bias, the assessor was a person not involved in the study and patient care.
The elevated exclusion of patients randomized to receive mesh implantation may represent a reluctance of surgeons to
implant a mesh prophylactically, especially in patients excluded because of a terminal stage of disease. This approach
represents another limitation of this study. However, post hoc analysis revealed no major different baseline characteristics
in patients intraoperatively excluded. Such reluctance to implant a mesh highlights the need for a better definition of
patients who benefit from mesh implantation.

Conclusions
Prophylactic intraperitoneal mesh implantation in patients at risk for incisional hernia is feasible and effective to prevent
hernia formation. Adverse effects of mesh implantation include delayed wound healing of SSI, early postoperative pain,
and reduced trunk extension.

Notes

Supplement 1.

Trial Protocol
 Supplement 2.

eFigure. Range of Motion for Trunk Extension/Flexion

References
1. Muysoms FE, Antoniou SA, Bury K, et al. ; European Hernia Society . European Hernia Society guidelines on the
closure of abdominal wall incisions. Hernia. 2015;19(1):1-24. doi:10.1007/s10029-014-1342-5 [PubMed: 25618025]
[CrossRef: 10.1007/s10029-014-1342-5]

2. Höer J, Lawong G, Klinge U, Schumpelick V. [Factors influencing the development of incisional hernia. A
retrospective study of 2,983 laparotomy patients over a period of 10 years] [in German]. Chirurg. 2002;73(5):474-480.
[PubMed: 12089832]

3. Le Huu Nho R, Mege D, Ouaïssi M, Sielezneff I, Sastre B. Incidence and prevention of ventral incisional hernia. J Visc
Surg. 2012;149(5)(suppl):e3-e14. doi:10.1016/j.jviscsurg.2012.05.004 [PubMed: 23142402] [CrossRef:
10.1016/j.jviscsurg.2012.05.004]

4. Sørensen LT, Hemmingsen UB, Kirkeby LT, Kallehave F, Jørgensen LN. Smoking is a risk factor for incisional hernia.
Arch Surg. 2005;140(2):119-123. doi:10.1001/archsurg.140.2.119 [PubMed: 15723991] [CrossRef:
10.1001/archsurg.140.2.119]

5. O’Dwyer PJ, Courtney CA. Factors involved in abdominal wall closure and subsequent incisional hernia. Surgeon.
2003;1(1):17-22. doi:10.1016/S1479-666X(03)80004-5 [PubMed: 15568420] [CrossRef: 10.1016/S1479-
666X(03)80004-5]

6. Deerenberg EB, Harlaar JJ, Steyerberg EW, et al. . Small bites versus large bites for closure of abdominal midline
incisions (STITCH): a double-blind, multicentre, randomised controlled trial. Lancet. 2015;386(10000):1254-1260.
doi:10.1016/S0140-6736(15)60459-7 [PubMed: 26188742] [CrossRef: 10.1016/S0140-6736(15)60459-7]

7. Millbourn D, Cengiz Y, Israelsson LA. Effect of stitch length on wound complications after closure of midline incisions:
a randomized controlled trial. Arch Surg. 2009;144(11):1056-1059. doi:10.1001/archsurg.2009.189 [PubMed:
19917943] [CrossRef: 10.1001/archsurg.2009.189]

8. Bhangu A, Fitzgerald JE, Singh P, Battersby N, Marriott P, Pinkney T. Systematic review and meta-analysis of
prophylactic mesh placement for prevention of incisional hernia following midline laparotomy. Hernia. 2013;17(4):445-
455. doi:10.1007/s10029-013-1119-2 [PubMed: 23712289] [CrossRef: 10.1007/s10029-013-1119-2]

9. Timmermans L, de Goede B, Eker HH, van Kempen BJ, Jeekel J, Lange JF. Meta-analysis of primary mesh
augmentation as prophylactic measure to prevent incisional hernia. Dig Surg. 2013;30(4-6):401-409.
doi:10.1159/000355956 [PubMed: 24217341] [CrossRef: 10.1159/000355956]

10. Jairam AP, Timmermans L, Eker HH, et al. ; PRIMA Trialist Group . Prevention of incisional hernia with prophylactic
onlay and sublay mesh reinforcement versus primary suture only in midline laparotomies (PRIMA): 2-year follow-up of a
multicentre, double-blind, randomised controlled trial. Lancet. 2017;390(10094):567-576. doi:10.1016/S0140-
6736(17)31332-6 [PubMed: 28641875] [CrossRef: 10.1016/S0140-6736(17)31332-6]

11. Muysoms FE, Detry O, Vierendeels T, et al. . Prevention of incisional hernias by prophylactic mesh-augmented
reinforcement of midline laparotomies for abdominal aortic aneurysm treatment: a randomized controlled trial. Ann Surg.
2016;263(4):638-645. doi:10.1097/SLA.0000000000001369 [PubMed: 26943336] [CrossRef:
10.1097/SLA.0000000000001369]

12. García-Ureña MA, López-Monclús J, Hernando LA, et al. . Randomized controlled trial of the use of a large-pore
polypropylene mesh to prevent incisional hernia in colorectal surgery. Ann Surg. 2015;261(5):876-881.
doi:10.1097/SLA.0000000000001116 [PubMed: 25575254] [CrossRef: 10.1097/SLA.0000000000001116]

13. Strzelczyk JM, Szymański D, Nowicki ME, Wilczyński W, Gaszynski T, Czupryniak L. Randomized clinical trial of
postoperative hernia prophylaxis in open bariatric surgery. Br J Surg. 2006;93(11):1347-1350. doi:10.1002/bjs.5512
[PubMed: 17006977] [CrossRef: 10.1002/bjs.5512]

14. 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;35(2):297-301. doi:10.1007/s00268-010-0874-9 [PubMed: 21136057] [CrossRef:
10.1007/s00268-010-0874-9]
15. Klink CD, Junge K, Binnebösel M, et al. . Comparison of long-term biocompability of PVDF and PP meshes. J
Invest Surg. 2011;24(6):292-299. doi:10.3109/08941939.2011.589883 [PubMed: 22047202] [CrossRef:
10.3109/08941939.2011.589883]

16. 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;13(2):167-172. doi:10.1007/s10029-
008-0435-4 [PubMed: 18853228] [CrossRef: 10.1007/s10029-008-0435-4]

17. Bevis PM, Windhaber RA, Lear PA, Poskitt KR, Earnshaw JJ, Mitchell DC. Randomized clinical trial of mesh versus
sutured wound closure after open abdominal aortic aneurysm surgery. Br J Surg. 2010;97(10):1497-1502.
doi:10.1002/bjs.7137 [PubMed: 20603858] [CrossRef: 10.1002/bjs.7137]

18. Abo-Ryia MH, El-Khadrawy OH, Abd-Allah HS. Prophylactic preperitoneal mesh placement in open bariatric
surgery: a guard against incisional hernia development. Obes Surg. 2013;23(10):1571-1574. doi:10.1007/s11695-013-
0915-1 [PubMed: 23512444] [CrossRef: 10.1007/s11695-013-0915-1]

19. Weissler JM, Lanni MA, Hsu JY, et al. . Development of a clinically actionable incisional hernia risk model after
colectomy using the Healthcare Cost and Utilization Project. J Am Coll Surg. 2017;225(2):274-284.e1.
doi:10.1016/j.jamcollsurg.2017.04.007 [PubMed: 28445797] [CrossRef: 10.1016/j.jamcollsurg.2017.04.007]

20. Goodenough CJ, Ko TC, Kao LS, et al. . Development and validation of a risk stratification score for ventral
incisional hernia after abdominal surgery: hernia expectation rates in intra-abdominal surgery (the HERNIA Project). J Am
Coll Surg. 2015;220(4):405-413. doi:10.1016/j.jamcollsurg.2014.12.027 [PMCID: PMC4372474] [PubMed:
25690673] [CrossRef: 10.1016/j.jamcollsurg.2014.12.027]

21. Armañanzas L, Ruiz-Tovar J, Arroyo A, et al. . Prophylactic mesh vs suture in the closure of the umbilical trocar site
after laparoscopic cholecystectomy in high-risk patients for incisional hernia: a randomized clinical trial. J Am Coll Surg.
2014;218(5):960-968. doi:10.1016/j.jamcollsurg.2014.01.049 [PubMed: 24680572] [CrossRef:
10.1016/j.jamcollsurg.2014.01.049]

22. Yamada T, Okabayashi K, Hasegawa H, et al. . Age, preoperative subcutaneous fat area, and open laparotomy are
risk factors for incisional hernia following colorectal cancer surgery. Ann Surg Oncol. 2016;23(suppl 2):S236-S241.
doi:10.1245/s10434-015-4462-y [PubMed: 25743333] [CrossRef: 10.1245/s10434-015-4462-y]

23. Seo GH, Choe EK, Park KJ, Chai YJ. Incidence of clinically relevant incisional hernia after colon cancer surgery and
its risk factors: a nationwide claims study. World J Surg. 2018;42(4):1192-1199. doi:10.1007/s00268-017-4256-4
[PubMed: 28956105] [CrossRef: 10.1007/s00268-017-4256-4]

24. Itatsu K, Yokoyama Y, Sugawara G, et al. . Incidence of and risk factors for incisional hernia after abdominal surgery.
Br J Surg. 2014;101(11):1439-1447. doi:10.1002/bjs.9600 [PubMed: 25123379] [CrossRef: 10.1002/bjs.9600]

25. Bosanquet DC, Ansell J, Abdelrahman T, et al. . Systematic review and meta-regression of factors affecting midline
incisional hernia rates: analysis of 14,618 patients. PLoS One. 2015;10(9):e0138745.
doi:10.1371/journal.pone.0138745 [PMCID: PMC4577082] [PubMed: 26389785] [CrossRef:
10.1371/journal.pone.0138745]

26. Muysoms FE, Miserez M, Berrevoet F, et al. . Classification of primary and incisional abdominal wall hernias. Hernia.
2009;13(4):407-414. doi:10.1007/s10029-009-0518-x [PMCID: PMC2719726] [PubMed: 19495920] [CrossRef:
10.1007/s10029-009-0518-x]

27. Horan TC, Gaynes RP, Martone WJ, Jarvis WR, Emori TG. CDC definitions of nosocomial surgical site infections,
1992: a modification of CDC definitions of surgical wound infections. Am J Infect Control. 1992;20(5):271-274.
doi:10.1016/S0196-6553(05)80201-9 [PubMed: 1332552] [CrossRef: 10.1016/S0196-6553(05)80201-9]

28. Veljkovic R, Protic M, Gluhovic A, Potic Z, Milosevic Z, Stojadinovic A. Prospective clinical trial of factors
predicting the early development of incisional hernia after midline laparotomy. J Am Coll Surg. 2010;210(2):210-219.
doi:10.1016/j.jamcollsurg.2009.10.013 [PubMed: 20113942] [CrossRef: 10.1016/j.jamcollsurg.2009.10.013]

29. Kurmann A, Barnetta C, Candinas D, Beldi G. Implantation of prophylactic nonabsorbable intraperitoneal mesh in
patients with peritonitis is safe and feasible. World J Surg. 2013;37(7):1656-1660. doi:10.1007/s00268-013-2019-4
[PubMed: 23568247] [CrossRef: 10.1007/s00268-013-2019-4]

30. Werdin F, Tennenhaus M, Schaller HE, Rennekampff HO. Evidence-based management strategies for treatment of
chronic wounds. Eplasty. 2009;9:e19. [PMCID: PMC2691645] [PubMed: 19578487]
31. Gonzalez R, Ramshaw BJ. Comparison of tissue integration between polyester and polypropylene prostheses in the
preperitoneal space. Am Surg. 2003;69(6):471-476. [PubMed: 12852503]

32. Majumder A, Petro CC, Liu L, Fayezizadeh M, Novitsky YW. Development of a novel murine model for treatment
of infected mesh scenarios. Surg Endosc. 2017;31(2):922-927. doi:10.1007/s00464-016-5056-x [PubMed: 27351653]
[CrossRef: 10.1007/s00464-016-5056-x]

33. Petersen S, Henke G, Freitag M, Faulhaber A, Ludwig K. Deep prosthesis infection in incisional hernia repair:
predictive factors and clinical outcome. Eur J Surg. 2001;167(6):453-457. doi:10.1080/110241501750243815
[PubMed: 11471671] [CrossRef: 10.1080/110241501750243815]

34. Brandi CD, Roche S, Bertone S, Fratantoni ME. No enterocutaneous fistula development in a cohort of 695 patients
after incisional hernia repair using intraperitoneal uncoated polyproylene mesh. Hernia. 2017;21(1):101-106.
doi:10.1007/s10029-016-1530-6 [PubMed: 27522361] [CrossRef: 10.1007/s10029-016-1530-6]

35. Lasses Martínez B, Peña Soria MJ, Cabeza Gómez JJ, et al. . Surgical treatment of large incisional hernias with
intraperitoneal composite mesh: a cohort study. Hernia. 2017;21(2):253-260. doi:10.1007/s10029-016-1557-8
[PubMed: 28008551] [CrossRef: 10.1007/s10029-016-1557-8]

36. Scholtes M, Kurmann A, Seiler CA, Candinas D, Beldi G. Intraperitoneal mesh implantation for fascial dehiscence
and open abdomen. World J Surg. 2012;36(7):1557-1561. doi:10.1007/s00268-012-1534-z [PubMed: 22402974]
[CrossRef: 10.1007/s00268-012-1534-z]

Figures and Tables

Figure 1.

CONSORT Diagram
Table 1.
Baseline Patient Characteristics a

Characteristic Control Group (n = 81) Mesh Group (n = 69)

Age, median (IQR), y 65 (56.5-70) 67 (58-72)
BMI, mean (SD) 26.7 (4.8) 27.6 (4.6)
ASA classification
1-2 19 (23.5) 18 (26.1)
3 55 (67.9) 47 (68.1)
4 7 (8.6) 4 (5.8)
Immunosuppressants or corticosteroid therapy 3 (3.7) 4 (5.8)
Incisional hernia risk factors
BMI>25 50 (61.7) 51 (73.9)
Diagnosis of neoplastic disease 67 (82.7) 54 (78.3)
Male 56 (69.1) 46 (66.7)
Previous laparotomy 60 (74.1) 51 (73.9)
Type of surgery
Upper GI tract 12 (14.8) 14 (20.3)
Lower GI tract 19 (23.5) 17 (24.6)
Hepatobiliary 18 (22.2) 20 (29.0)
Pancreatic 30 (37.0) 15 (21.7)
Other 2 (2.5) 3 (4.3)
Type of incision
Midline laparotomy 30 (37.0) 31 (44.9)
Transverse laparotomy 51 (63.0) 38 (55.1)
Operation duration, mean (SD), min 293 (109) 275 (102)
Mesh implantation duration, mean (SD), min NA 25 (8)

Abbreviations: ASA, American Society of Anesthesiologists; BMI, body mass index (calculated as weight in kilograms
divided by height in meters squared); GI, gastrointestinal; IQR, interquartile range; NA, not applicable.
a
Data are presented as number (percentage) of patients unless otherwise specified.
Figure 2.

Cumulative Hazard Curves for Incisional Hernia in the Mesh and Control Groups
The curves are significantly different (P = .03, log-rank test).
Table 2.
Surgical Complications, Length of Hospital Stay, and Mortality

Variable Control Mesh Effect Size, % P

a a
Group Group (95% CI) Value
b
Hematoma 1/81 (1.2) 1/69 (1.4) 0.2 (−7 to 7) >.99
b
Intestinal postoperative paralysis 4/81 (4.9) 3/69 (4.4) 0.5 (−9 to 9) >.99
b
Subsequent operation 8/81 (9.9) 5/69 (7.3) 2.6 (−8 to 13) .77
c
Pain on VAS, mean (SD)
d
POD1 1.2 (1.2) 1.6 (1.5) 0.4 (−0.04 to 0.88) .07
d
POD3 0.6 (0.8) 0.9 (1.4) 0.3 (−0.11 to 0.69 .15
d
POD5 1.24 (1.1) 1.26 (1.6) 0.02 (−0.57 to 0.61) .94
d
Length of hospital stay, median (IQR), d 13.5 (8.75- 13 (9-17) 0.5 (−3 to 1) .46
23.5)
b
In-hospital mortality 3/81 (3.7) 1/69 (1.4) 2.3 (−6 to 10) .62
Patients with SSIs
Superficial incision 7/69 (10.1) 5/61 (8.2)
Deep incisional 3/69 (4.4) 2/61 (3.3)
b
Organ or space 8/69 (11.6) 4/61 (6.5) 8.1 (−8 to 23) .30

Total 18/69 (26.1) 11/61

(18.0)
e
Time to final wound healing among patients with SSI, 5 (1-9) 8 (6-24) 3 (0 to 14) .03
median (IQR), wk
f b
Subsequent surgery for chronic wound 1/69 (1.5) 4/61 (6.6) 5.1 (−5 to 14) .19
Small-bowel obstruction
b
6 wk to 12 mo 1/50 (2.0) 1/45 (2.2) 0.2 (−11 to 10) >.99
b
12 mo to 36 mo 2/29 (6.9) 1/27 (3.7) 3.2 (−15 to 21) >.99

Abbreviations: IQR, interquartile range; POD, postoperative day; SSI, surgical site infection; VAS, visual analog scale.
a
Data are presented as number per total number (percentage) of patients unless otherwise specified.
b
Fisher exact test.
c
Mean scores for all patients in each group from 0 to 10, with 0 indicating no pain and 10 indicating worst imaginable
pain.
d
Two-tailed, unpaired t test.
e
Mann-Whitney test.
f
Equivalent to number of mesh explantations in mesh group.
Table 3.
Abdominal Pain Perceptiona

Pain Control Group Mesh Group Effect Size, % (95% CI) P Value

Presence of Abdominal Pain

b
6 wk 26/59 (44.1) 34/52 (65.4) 21.3 (4 to 41) .04
b
12 mo 16/45 (35.6) 14/40 (35.0) 0.6 (−20 to 22) >.99
b
36 mo 7/30 (23.3) 6/29 (20.7) 2.6 (−20 to 25) >.99
Daily Abdominal Pain (Among Patients With Pain)
b
6 wk 10/26 (38.5) 17/34 (50.0) 11.5 (−13 to 39) .44
b
12 mo 4/16 (25) 7/14 (50) 25 (−6 to 63) .26
b
36 mo 3/7 (42.8) 2/6 (33.3) 9.5 (−43 to 55) >.99
c
Intensity of Pain Measured With VAS Score (Among All Patients)
d
6 wk 0.83 (1.61) 1.61 (2.27) 0.78 (0.10 to 1.46) .02
d
12 mo 0.86 (1.88) 1.2 (2.23) 0.34 (−0.50 to 1.17) .42
d
36 mo 0.67 (1.56) 0.73 (2.02) 0.07 (−0.87 to 1.00) .89

Abbreviation: VAS, visual analog scale.

a
Data are presented as number per total number (percentage) of patients for presence of abdominal pain and daily
abdominal pain and mean (SD) for intensity of pain.
b
Fisher exact test.
c
VAS scores from 0 to 10, with 0 indicating no pain and 10 indicating worst imaginable pain.
d
Two-tailed, unpaired t test.