The Mesh-RTL Project for Prevention of Incisional Hernia: Clinical Trial of Non-inferiority to Compare Two Aponeurotic Closure Techniques in Midline Laparotomy in Patients With Elevated Risk for Hernia
Phase: NA
Conditions: Hernia Incisional
Sponsor: Hospital Regional de Alta Especialidad del Bajio

The Mesh-RTL Project for Prevention of Incisional Hernia. Clinical Trial of Non-inferiority to 
Compare Two Aponeurotic Closure Techniques in Midline Laparotomy in Patients With 
Elevated Risk for Hernia. 
 
 
Sponsor: 
Responsible Party: 
 
 
 
Collaborators: 
 
 
 
Approval Number: CI/HRAEB/2018/008  
Board Name: Comité de ética en investigación  
Board Affiliation: CNBCEI-11-CEI-004-20170731 
 
Friday October 18th 2019 
Introduction: 
The laparotomy is a surgical incision into the abdomen cavity performed to examine the abdominal 
and retroperitoneal organs. It is classified according to the medical indication: exploratory, 
therapeutic, stagemaker, and recently added "damage-control" laparotomy. 
There exists so many ways to access the abdominal cavity, usually in relation with the organ or 
structure to treat; being classified in midline laparotomy, paramedian, transversal, oblique, 
abdominal-thoracic, etc. 
Either an emergency or scheduled procedure, the more usual and functional continues being the 
midline laparotomy, since it allows a broader and faster approach, with less bleeding and easily to 
extend if it becomes necessary. 
Both the evisceration/eventration and the hernia are considered the most frequent complication of the 
midline laparotomy with a high morbidity and mortality related. Conditions that will require a second 
intervention, in Mexico represent the seventh cause of elective surgery and fourth cause of emergency 
procedures. 
So far only the use of the mesh has proven useful in reducing this complication. Our group published 
in 2016 a clinical trial where it showed that the technique is safe and effective to reduce the presence 
of incisional hernia, however the use of the mesh brings with it problems such as cost, possibility and 
use in contaminated cavities and postoperative pain Therefore, the use of the RTL technique as an 
alternative means to this will help to have one more option for the management of patients with a 
high risk of incisional hernia. 
Problem Statement: 
Does the RTL closing technique in the midline laparotomy has the same incident of herniation than 
the close with supraaponeurotic mesh in patient with elevated risk? 
Justification 
The presence of postincisional hernia need to be considerate as a serious disease, insomuch as it carry 
on highs rates of morbimortality. The presence of this eventuality is among 0.4-1.2% in elective 
Hospital Regional de Alta Especialidad del Bajio 
Principal Investigator 
Investigator: Edgard Lozada [elozada] 
Official Title: Master in clinical research 
Affiliation: Hospital Regional de Alta Especialidad del Bajio 
Juan Carlos Mayagoitia Gonzalez 
Eduardo Flores Gonzalez 

surgery and up to 30% in emergency procedures. 

It is calculated in de U.S.A. an approximate of 1 million of reinterventions a year to correct this 
condition, with the respective monetary, time and suffering cost to the patient and the health system. 
Given the seriousness, the ultimate global consensus has determinate three main axes to the surgical 
community to board: 
• Identify the relevance of the problem 
• Improve the theoretical knowledge and technical capacity in the closing of the abdominal 
wall 
• Implement prophylactic measures in the patients, especially in those with elevated risk. 
With the present study we aim to contribute to this global recommendations, comparing two closing 
techniques of the abdominal wall after a midline laparotomy in patients with elevated risk of 
herniation. Both techniques are proved safe and useful in other studies, with no comparison to date. 
Demonstrate that the use of RTL technique has a similar incidence of herniation than the mesh, in an 
attempt to prevent postincisional hernias after a midline laparotomy, will bring to the surgical 
community a cheaper and practical alternative to the mesh. 
Objectives: 
General: 
To determinate if the incidence of post-incisional hernia in patients with high risk after a midline 
laparotomy are similar between the closure of the abdominal wall with the RTL technique and the 
supraaponeurotic mesh closure reinforcement. 
Specifics: 
• To identify the patients with high risk using de validated HERNIA-Project Score. 
• To determinate the incidence of post-incisional hernia after one year of the initial midline 
laparotomy. 
• To compare the incidence of post-incisional hernia between the two groups. 
• To describe the complications related to each closure technique. 
Hypothesis: 
Ho Hypothesis: 
There is no difference in the incidence of post-incisional hernia between the RTL technique and the 
reinforcement with supraaponeurotic mesh closure wall. 
H1 Hypothesis: 
There is difference in the incidence of post-incisional hernia between the RTL technique and the 
reinforcement with supraaponeurotic mesh closure wall. 
 
 
Sample size: 
The sample size was calculated according to the formula published by Bouemn et all 2015, and 
based on the results of Kholer and collaborators 2019, where they found in which a percentage of 

success was estimated with the standard treatment of 18.5% compared to the experimental 
management of 7.2%, with a margin of no less than 3%, with an alpha for a tail of 0.05%, and a beta 
of 20 %, with a percentage of estimated losses of approximately 10%, a total of 195 patients per group 
was obtained. 
Statistical analysis Date are presented as frequency and percentage, comparisons between groups 
were using the χ2 test for binary data or Fisher´s exact test. Continuous variables are presented as 
median and range interquartile range and were compared using the Mann-Whitney U-test or t student 
test if they meet normal criteria. p-Values of less than 0.05 were considered significant. Statistical 
analyses were performed with SPSS version 25.0.0. Analysis by intention to treat was used. 
 
 
Study Type: 
Primary Purpose: 
Study Phase: 
Interventional Study Model: 
 
Number of Arms: 
Masking: 
Allocation: 
Enrollment: 
 
 
Primary Outcome Measure: 
 
 
1. Incisional Hernia 
 
any abdominal wall gap with or without bulge in the area of a postoperative scar perceptible or 
palpable by clinical exemination 
[Time Frame: 12 and 24 months] 
Secondary Outcome Measures: 
2. postoperative complications 
an undesirable and unintended result of an operation affecting the patient that occurs as a 
direct result of the operation. Haematoma, Facial dehiscence, mesh removal, ileus, 
reinterventions, re-admissions and death 
[Time Frame: 1 month, 1 and 2 years] 
 
 
Elegibility: 
 
Minimum Age: 
18 Years 
Maximum Age: 
70 Years 
Sex: 
All 
Gender Based: 
No 
Interventional 
Treatment 
Phase 4 
Parallel Assignment 
Clinical trial of non-inferiority 
2 
Triple (Participant, Care Provider, Investigator) 
Randomized 
390 [Anticipated] 

Accepts Healthy Volunteers: Yes 
Criteria: 
Inclusion Criteria: 
• Patients older than 18 years undergoing midline laparotomy, 
independently of diagnostic or condition, elective or emergency
surgery 
• Patients with a score equal or greater than 7 of the hernia score 
• Patients who accept to participate and sign the informed 
consent 
Exclusion Criteria: 
• Patients managed with open abdomen or with the impossibility 
of close the wall 
• Patients who had a previous incisional hernia or patients who 
are participing in anohter trial 
• Patients with a life expectative less than 12 months 
• Pregnant patients Patients with the antecedent of rejection of 
prosthesic material 
 
 
Revised Hernia Score. 
 
 
 
 
Arms and interventions: 
 
Active Comparator: Onlay Mesh Reinforcement group 
The midline fascia was closed with running, slowly absorbable sutures (PDS 1-0) with a 
recommended suture length to wound length ratio of 4:1. An anterior plane with a width of about 8 
cm was created between the anterior fascia and the subcutis. A Lightweight polypropylene mesh was 
used and placed on the anterior rectus fascia with an overlap of 3 cm. The mesh was fitted in the 
dissected space and it was fixed with PDS 2-0 suture. Fixing points are placed taking the mesh and 
the anterior fascia of the rectus muscle, at a distance of 3 cm between each point until completing its 
circunference. 
Experimental: RTL reinforcement group 
The RTL suture is placed parallel at a distance of 0.5 cm from the fascial margin. Ideally the thread 
should lie between the anterior and the posterior rectus muscle sheath; there should be no contact with 
the rectus muscle. A nonabsorbable monofilamental polypropylene thread and a 65-mm ½ needle are 
used. Around this longitudinal thread, the continuous suture for fascial closure is introduced 
immediately lateral to the thread; with running, slowly absorbable sutures (PDS 1-0) with a 
recommended suture length to wound length ratio of 4:1. An anterior plane with a width of about 8 
cm was created between the anterior fascia and the subcutis. 

 
 
 
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