NoPro - Norwegian Hernia Prophylaxis Study: Onlay Mesh Versus Small Bite Suture Technique Closure of Midline Laparotomies
Phase: NA
Conditions: Incisional Hernia After Midline Laparotomy, Quality of Life (QOL), Burst Abdomen, Surgical Site Infections
Sponsor: Sykehuset Innlandet HF

1  
  
Study protocol  
  
Document date: 25.11.2024  
  
Project title:  NoPro - Norwegian Hernia Prophylaxis study: Onlay mesh versus small bite 
suture technique closure of midline laparotomies.  
  
  
REK number: 761933  
  
  
Project managers:   
Gjertrud Hole Kjøstolfsen, MD, SIHF Hamar  
Jorunn Skattum, MD PhD, SIHF Hamar  
Jan Roland Lambrecht, MD PhD, SIHF Hamar  
 
Revision history:  
06.02.2025 – revision of exclution criteriae 
18.02.2025 – removal of recommandation of postoperative hernia binder 
  
 
 
 
 
  
  
  
  
  
  
  
  
  
  
 

2  
  
Table of content  
  
1. List of abbreviations  
2. Title  
3. Project group  
4. Introduction  
5. Aim  
6. Study design  
7. Sample size  
8. Time frame  
9. Inclusion criteriae  
10. Exclusion criteriae  
11. Description of consent  
12. End of study  
13. Procedure description  
14. Patient data  
15. Antibiotics  
16. Thromboprophylaxis  
17. Open abdomen/delayed closure of the fascia  
18. Postoperative activity restrictions  
19. Evaluation/follow up  
20. Data storage and statistics  
21. Ethics  
22. Funding  
23. Contact  
24. Appendix  
25. References  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 

3  
  
1) List of abbreviations  
  
  
IH – incisional hernia  
  
LoS – Length of stay  
SIG – Sykehuset Innlandet Gjøvik (Gjøvik hospital)  
  
SIH – Sykehuset Innlandet Hamar (Hamar hospital)  
SIL – Sykehuset Innlandet Lillehammer (Lillehammer hospital)  
  
SL/WL - suture length/wound length  
  
SSO - surgical site occurrence  
  
PM – prophylactic mesh  
  
PROM – Patient Reported Outcome Measures  
  
QoL – quality of life  
  
  
 

4  
  
2) NoPro  
  
Norwegian Hernia Prophylaxis study: Onlay mesh versus small bite suture 
technique closure of midline laparotomies.  
  
  
3)  Project group  
  
Gjertrud Hole Kjøstolfsen (GHK), GI resident at SIH  
Jorunn Skattum (JS), consultant GI and Trauma surgeon at SIH, PhD. Project manager  
Jan Roland Lambrecht (JRL), consultant GI surgeon at SIH, PhD.   
  
  
  
4) Introduction  
  
Incisional hernia (IH) is a defect in the abdominal wall at the position of a surgical scar 
that leads to a protrusion of abdominal content through the defect. It is a common 
complication after midline laparotomy with incidences ranging from 9 % to 40 % in 
the general population (1-11) and up to 69 % in high-risk patients (5,12-14). Incisional 
hernias can cause chronic pain, reduced quality of life (QoL) (15), impaired abdominal 
wall function and there is a risk of bowel obstruction, incarceration and ischemia. IH 
are also a great cost to the society (16,17). Several studies on IH prevention have 
been performed. An established intervention to avoid IH is to add a synthetic mesh to 
the suture closure of the abdomen after midline laparotomy. Meta-analyses have 
shown that the use of a prophylactic mesh significantly reduces the rate of IH after 
laparotomy compared with suture alone (18-22). Reported IH rates after onlay mesh 
closure of midline laparotomies are listed in Table 1 and in table 2 the corresponding 
numbers 5 years postoperatively are shown. Onlay mesh increases the risk of seroma 
compared to suture (RR 2.21), but the rate of wound infections (RR 1.32) and 
hematomas (RR 1.19) are comparable (22). The suture technique also matters and 
slowly absorbable monofilament suture at a 4:1 ratio to the incision length and small 
(5 mm) suture bites and steps also seems to be important to reduce IH rate after 
laparotomy (23). The mesh intervention is not frequently used in Norway and there 
are no Norwegian studies on IH prevention after midline laparotomy. There are two 
ongoing multicenter studies studying prophylactic mesh versus small stitch suture 
technique; the Finish PREEMER study compares retro-rectus mesh position to suture 
(24) and the German HULC trial studies onlay mesh versus suture in elective 
laparotomies (25). Hopefully the results will guide us on when to use prophylactic 
meshes on Norwegian patients. This study is an effort to contribute to our common 
knowledge, as well as to inspire Norwegian surgeons to consider using prophylactic 
meshes.   
  
 
 

5  
  
Table 1 – studies on IH after onlay mesh placement  
  
Author  
Type of study  
Elective or 
emergency  
% IH with 
suture   
% IH with 
onlay mesh  
Follow up   
  
Hassan MA et  
al (21)  
Meta-analysis  
  
  
Elective 5   
Emergency 1   
Combined 1  
32 %  
10 %  
  
mean 27 m 
median 24 m  
  
Ulutas ME et al  
(26)  
  
RCT  
Emergency  
27 %  
4 %       
12 m  
Argudo N et al  
(27)  
  
Retrospective 
analysis  
Emergency  
33 %   
  
6 %  
  
Mean 17 m  
  
RCT= randomized controlled trial, IH = Incisional hernia, m= months  
  
  
Table 2 – Five years results of IH after onlay mesh  
Author  
Type of study  Elective or 
emergency  
% IH with 
suture  
% IH with 
onlay mesh  
Follow up   
Caro-Tarrago  
A et al (28)  
RCT  
Elective  
47 %   
5 %    
5 y  
Van den Dop  
LM et al  
(PRIMA) (29)  
RCT  
Elective   
  
53 %   
  
25 % *  
5 y  
RCT= randomized controlled trial, IH = Incisional hernia, y= years  
*10% of the patients in the onlay group did not receive a mesh  
  
5) Aim   
The primary endpoint is IH rate at 12 months after surgery in the midline laparotomy 
population at Sykehuset Innlandet (SI) comparing:      
small stitch linea alba closure (study group A) to small stitch linea alba closure + onlay 
polypropylene mesh (study group B).  
Secondary endpoints are:  

6  
  
- surgical site occurrences (SSO) in need of intervention (seromas, hematomas and 
wound infections)  
- burst abdomen   
- readmission rate and QoL at 30 days follow up (EQ-5D + VAS score) - QoL (EQ-5D and 
VAS score) at 12 months follow up.   
  
  
6) Study design  
The study design is experimental, with prospective randomization of all consenting 
consecutive patients that meet the inclusion criteria of having a midline laparotomy 
performed during their stay at SIH in the gastrointestinal and vascular surgical 
departments.   
  
Patients treated at the gastrointestinal surgical departments at SIL will also be 
included and follow the same study protocol and criteria for inclusion. SIG might also 
attend the study.  
  
Patients will be block randomized weekly. The project group members GHK and JS will 
perform the weekly randomization from closed envelopes every Monday morning 
and a sign will be placed at the OR entrance door, informing surgeons and OR nurses 
about the technique that should be performed that week. Group assignment will be 
blinded to the investigating radiologist as well as for the patients until the follow up at 
12 months.  
  
An interim analysis will be performed when 40 patients are included in each group. If 
the mesh has had to be removed in 20 patients or more, the study will be terminated.   
  
  
7) Sample size  
Based on results from comparable studies listed in Table 1 (onlay mesh versus suture) 
we estimate an IH rate of 30 % in group A and 10% in group B. We add on 20% loss to 
follow up at 12 months follow up due to the nature and known mortality rate in the 
emergency patient population amounting to about 70% of the laparotomies 
performed at SIH in 2023. With an alpha = 0.05 and power of 80% the number of 
patients needed in the study groups are 62 + 12 in each group, in total about 150 
patients. If the loss to follow up turns out to be higher than 20%, the number of 
included patients will be increased accordingly.  
  
 
 
  
 

7  
  
8) Time frame  
  
We plan to start the study in the autumn of 2024 after study approval and after 
training the involved surgeons and OR nurses in both the small stitch suture 
technique and the mesh application technique. We estimate inclusion to be complete 
at the end of 2026 and follow up at the end of 2027. During the following 6 months 
data will be analysed and the study results submitted for publication at the end of 
2028.  
  
  
9) Inclusion criteria  
  
Surgery predominantly done by midline laparotomy  
Age ≥ 18 years   
Written consent by patient/family  
Midline laparotomy with delayed closure  
No exclusion criteria  
  
  
10) Exclusion criteria  
  
Age < 18 years  
Pregnancy  
Previous abdominal midline hernia mesh repair  
Abdominal compartment syndrome  
Linea alba closure not possible  
Hernia in the midline with transverse diameter > 2 cm 
Life expectancy < 6 months 
  
  
11) Description of consent  
  
Patients will be asked to participate in the study at the outpatient clinic or during 
their stay at the ward before surgery. Written consent is mandatory to be included in 
the study. The participants can at any time withdraw their consent. The patient data 
will from then on not be used in future analysis. If the anonymous data at the time is 
already included in the analysis, the data will not be deleted.    
  
Elective surgery  
The patients who are included in an elective setting will in most cases be identified at 
the outpatient clinic by a surgeon. This is not necessarily the same surgeon who will 
perform the surgery on the operating day. The patient will give consent to a resident, 
a junior doctor or a nurse either at the outpatient clinic when the medical record is 
taken or when the patient arrives at the ward before surgery. By not involving the 

8  
  
operating surgeon in this matter, the pressure of participating in the study will be 
reduced.    
  
In some cases, the planned procedure of laparoscopy will be converted to a midline 
laparotomy perioperatively. If there is a high risk of conversion preoperatively, the 
patient will be offered to participate in the study given that the surgery is converted 
to a laparotomy.   
  
Emergency surgery  
The risk of developing IH after an emergency surgery is increased (OR 4.7 Cl 3.9-5.5) 
(30). The two studies published on onlay prophylactic synthetic mesh in emergency 
laparotomies show a reduction in IH in the mesh group (4% and 6%) compared to the 
group closed with suture alone (27,4% and 33%) (26,27). One study also shows a 
reduction in burst abdomen within the first 30 postoperative days (31). The current 
guidelines of European Hernia Society (EHS) and American Hernia Society (AHS) (32) 
make no recommendation regarding prophylactic mesh reinforcement in emergency 
laparotomy as “the data on mesh augmentation are heterogeneous and limited”. The 
guidelines states “More research is needed to draw definitive conclusions on 
potential benefits of mesh augmentation in patients undergoing emergency midline 
laparotomy and to identify subgroups of patients who might benefit from 
prophylactic mesh placement».   
  
In our opinion it is critical to include emergency laparotomies in this study as this is 
the patient group where surgeons are most reluctant to implement prophylactic 
mesh even though these patients are probably benefiting the most from 
reinforcement. Some of these patients will not be able to be included in the study 
due to the urgency of the operation or the state of the patient. However, patients 
with Glasgow Coma Scale score 15 that can confirm why they need surgery and what 
the treatment plan is, will generally be eligible for study inclusion if there is time 
before surgery. As in an elective setting, the patient will give his consent to the 
resident, the junior doctor or the nurse on call and not to the operating surgeon, to 
reduce the patients perceived pressure to consent to the study.    
  
  
12) End of study   
  
The study will end when the desired numbers of participants have been included 
(150).   
  
The study will be terminated if:  
  
  
- The estimated inclusion timespan doubles from 1,5 years to more than 3 years.  
  
- More than 30% of patients are lost to follow up during the first 12 months of the 
inclusion period significantly impacting on the estimated timeframe of the study.  

9  
  
  
- Interim analyses after 40 included patients in both study groups reveals that 20 
patients or more have had to have the mesh removed.  
 
 
13) Procedure description  
  
Study group A: small stitch suture closure of linea alba  
   
Closure of linea alba will be performed according to EHS guidelines (32):   
Slowly absorbable monofilament 0 suture (PDS plus 0) is used. The fascia is closed by 
running suture with minimum 4:1 suture: incision length ratio with small bites 
technique (stitches 5 mm apart, 5-9 mm stitch depth on both sides, see Figure 1). 
Self-locking nots are tied in both ends of the suture line. A subcutaneous drain is used 
at the discretion of the surgeon and the skin is closed with skin clips.  
  
The subcutaneous drain will be removed according to standard postoperative 
treatment, typically when output is below 30-50 ml/24 hours, and skin clips 10-14 
days postoperative in patients without signs of SSI. The OR nurse will together with 
the surgeon, measure used suture material and incision length on individual patients 
and the data will be written on a registration form for each patient.  
  
  
  
  
Figure 1  
  
  
 
 
  

10  
  
Study group B: small stitch suture closure of linea alba + onlay polypropylene mesh 
(Macroporous Polypropylene Mesh)  
  
The same suture technique and suture material as described for study group A is used  
in study group B to close linea alba. The anterior rectus fascia is dissected 3 
centimetres in all directions from the incision and a macroporous polypropylene 
mesh cut to fit this area is then applied (Figure 2), overlapping fascial edges by 3 cm 
in all directions as shown on Figure 2. The mesh used are cut from 15 cm x 15 cm 
meshes and if the incision is longer than 9 cm, more than one stripe is needed to 
cover the suture line, and the mesh stripes will overlap 3 cm. The mesh will be 
sutured to the fascia by interrupted PDS 2.0 stitches 3 cm apart around the 
circumference of the mesh. A subcutaneous drain is placed on top of the mesh before 
the skin is closed with skin clips. The drain will be removed after 2-5 days according to 
output below 30-50 ml/24 hours. Skin clips will be removed after 10-14 days in 
patients without signs of subcutaneous infections.  
The OR nurse will together with the surgeons, measure used suture material and 
incision length on individual patients and the data will be written on a registration 
form for each patient.  
 
  
  
Figure 2  
  
 
 
 
  

11  
  
14) Patient data   
  
Demographic and clinical data that will be registered from electronic patients’ charts 
are:  
  
Age  
Gender  
Work/profession (physical or non-physical)  
Medication (immunosuppression/steroids)  
ASA  
Diabetes Mellitus   
Connective tissue disease    
BMI  
Smoking  
Elective/Planned vs emergency surgery  
Surgical procedure performed  
Contamination classification (1-4)  
Antibiotics (prophylactic/treatment, type?)  
Surgery time  
Length of stay (LOS)  
Subcutaneous drain removed on day number  
Intervention: Suture or Mesh   
Suture length  
Incision length   
SL/WL   
Burst abdomen  
Sick leave  
Discharge to home or home care facility  
Clavien Dindo complication grade ≥ 3 during hospital stay  
SSO intervention  
  
  
15) Antibiotics  
  
All patients receive prophylactic antibiotics or treatment according to procedure and 
status, typically Cefalotin 2g in vascular procedures and Doxycyklin 400 mg + 
Metronidazole 1g in GI procedures, alternatively Piperacillin Tazobactam treatment in 
contaminated and/or emergency patients with contaminated abdominal cavity.  
  
  
16)  Thromboprophylaxis  
  
All patients receive anticoagulation treatment as decided by the surgeon. Typically, 
low molecular weight heparin (LMWH) after surgery for at least 10 days (4 weeks 

12  
  
after cancer surgery). Vascular procedures are often followed by platelet inhibition 
after discharge.  
  
  
17) “Open abdomen” / Delayed closure of the fascia  
  
In the situations where the laparotomies cannot be closed primarily, the patients will 
be randomized initially at the time of the primary operation and then closed according 
to the assigned group at the final closure of the fascia.   
  
 
18) Reoperation within the first 12 months  
  
In the event of relaparotomy after initial closure within the first 12 months, the patient 
is further analysed as part of his original group (A and B) as in intention to treat 
manner. If a patient is reoperated due to burst abdomen, a mesh will likely be added 
for patients in group A (standard suture closure without mesh). These patients are also 
further analysed as a part of their original randomized group as in intention to treat 
manner.   
  
  
19) Postoperative activity restrictions  
  
All patients will have physiotherapist-guided mobilization after surgery focusing on 
unstrained (low abdominal pressure) mobilization for 8 weeks after surgery.  
  
  
20) Evaluation/Follow up  
  
Patients will be interviewed and examined 4-6 weeks and 12 months after surgery in  
the outpatient clinic. In cases where the patient cannot show up to a clinical  
examination, a telephone interview will be performed. Incisional hernia occurrence  
will be  evaluated clinically and by CT examination after 12 months. A QoL (EQ-5D) 
score and VAS-score will be performed preoperatively in patients scheduled for 
elective surgery. This cannot be performed in emergent cases due to considerable 
bias implicated by acute illness and the need for surgery. QoL (EQ-5D) score will be 
calculated at the scheduled postoperative follow ups in all patients. Total length of 
sick leave will also be registered as well as average pain over the last 24-48 hours 
measured by VAS-score. Any sign of symptomatic SSO will be further explored by 
ultrasound or CT scan at 4-6 weeks follow up.   
  
In the application for study approval by the regional ethics committee and the local 
data protection officer, we will apply for storage of data over time to perform 
longterm follow up as well (5 years follow up). In accordance, we will ask for written 
consent from the patients to contact them after one and five years postoperatively. 

13  
  
 
21) Data storage and statistics  
  
Registration forms will be stored in coded lockers in the department. Extracted data  
from electronical medical charts (DIPS extracted data) will be entered with  
identification code into Excel and thereafter transferred for analyses into SPSS. We 
might use LEDIDI for data storage if this system becomes available during the study 
period. The identification code will be stored separately on a safe institutional server 
domain approved and provided by the hospital.   
  
  
  
Descriptive data analyses will be performed.  
  
  
  
Continuous data will be analysed by Mann-Whitney U test and multiple logistic  
 
regression.  
  
  
  
Categorical data will be analysed by Chi-Square tests and multiple logistic regression.  
  
  
  
Kaplan-Meier analyses for IH rate comparison will be conducted.  
  
  
  
Interim analyses of group differences will be performed as Mann-Whitney U test or  
 
Chi-Square tests as appropriate.  
  
  
  
22) Ethics  
  
Study approval will be applied to the regional ethics committee and the local data  
protection officer.   
  
All patients will receive standard care in abdominal wall closure, but group B patients 
will probably benefit from the additional mesh by a potential reduced risk of IH after 
surgery. The previous studies conducted on onlay prophylactic mesh (21,26-29) 
show a significant reduction in IH rate with the use of a prophylactic mesh. As data 
are not considered strong enough by the hernia society in Europe or USA to strongly 
recommend the use of prophylactic meshes (32), we cannot claim to deprive some 
patients of better outcome by not giving them a mesh prophylaxis.  
  
In our experience most Norwegian surgeons are reluctant to apply prophylactic 
meshes as they are not familiar with the method and afraid of infections. It is our 
belief that if it were not for the participation of this study, most of the patients would 
not receive a prophylactic mesh as it is not the standard of care today.  We hope that 
this study will contribute to increase the use of prophylactic mesh in midline 
laparotomies and create more awareness of the procedure to the general Norwegian 
surgeons.   
  
  

14  
  
Seroma and infections  
As previous studies have shown that implementation of prophylactic onlay mesh 
increases the risk of seroma, some of the patients in study group B may receive an 
unnecessary complication. However, we believe that the benefit of reducing IH is 
greater than the possible risk for this non-serious complication that in most cases 
may be resolved either spontaneously or by bedside procedures.   
  
The mesh is made of inert large pore material (polypropylene) that facilitates good 
vascular ingrowth which makes the resistance to infection good due to antibiotic 
penetration in vascularized tissue. The mesh can easily be removed with a surgical 
procedure in local or general anaesthesia. Fluid accumulation around the mesh 
(seroma) is probably prevented by adding a subcutaneous suction drain that are 
removed with a slight discomfort (with oral or iv pain medication) after a few days. In 
most cases the drains are removed without pain due to the epidural anaesthesia 
most of the patients have the first days after laparotomy.   
  
Mesh infections are rare, and the incidence of mesh removal is low in published 
studies (21,26,27,29). The risk of a potential harmful procedure performed in general 
anaesthesia is therefore very small. By choosing onlay position of the mesh, the risk 
of organ injury in a reoperation is reduced and the layers used for potential later 
hernia repair preserved.  
  
  
Excluded groups  
We have chosen to exclude pregnant woman, children and patients who have 
previously gone through abdominal midline hernia mesh repair from the study. There 
are no studies conducted on pregnant women or children on this matter. Pregnant 
women and children have abdominal walls that are, respectively, expanding and a 
rupture or tear of the abdominal wall next to a fixed area (the edge of the mesh) is 
possible. The patients previously treated for abdominal midline hernia mesh repair 
need a different closing technique after laparotomy, and these patients are therefore 
not eligible for this study.  
  
  
23) Funding  
  
  
The added cost generated by the study is estimated to:  
- about 15 minutes OR time (58)  
- about 300 NOK in added materials (mesh + drain)   
- outpatient clinic appointment at 12 months  
- CT scan at 12 months  
- SPSS, LEDIDI licenses or similar for 1-2 study group members  
  
  
  
These costs are funded by the surgical department and signed for by the director of  
 
the surgical department, Lars Martin Rekkedal.  

15  
  
24) Contact  
  
  
Gjertrud Hole Kjøstolfsen, MD, gjertrud.hole.kjostolfsen@sykehuset-innlandet.no.   
  
M +47 46432356  
  
  
Jorunn Skattum, MD PhD, jorunn.skattum@sykehuset-innlandet.no.   
  
M +47 93253940  
  
  
Jan Roland Lambrecht, MD PhD, jan.lambrecht@sykehuset-innlandet.no.  
  
M +47 99703962  
  
  
25) Appendix   
  
- Consent form  
- Registration forms  
  
  
26) References   
  
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2. Fink C, Baumann P, Wente MN et al. Incisional hernia rate 3 years after midline 
laparotomy. Br J Surg 2014 101:51-54  
3. Albertsmeier M, Seiler CM, Fischer et al. Evaluation of the safety and efficacy of 
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10. Llaguna OH, Avgerinos DV, Nagda P et al. Does prophylactic biologic mesh placement 
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Wall Surgery: A Systematic Review and Meta-analysis. World J Surg. 2021 
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23. Deerenberg EB, Harlaar JJ, Steyerberg EW et al. Small bites versus large bites for 
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25. Heger P, FeiBt M, Krisam J et al. Hernia reduction following laparotomy using small 
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Hernia 2023 27:883-893  
27. Argudo N, Pereira JA, Sancho JJ et al. Prophylactic synthetic mesh can be safely used 
to close emergency laparotomies, even in peritonitis. Surgery 2014 
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