The Mesh-RTL Project, for Prevention of Incisional Hernia (RTL)

February 9, 2022 updated by: Edgard Lozada, 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

Introduction:

By definition, the laparotomy is a surgical incision into the abdomen cavity performed to examine the abdominal and retroperitoneal organs. 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. The objective of this study is to determine 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.

Material and Methods: Clinical trial comparing the use of mesh against the RTL technique for post-incisional hernia prophylaxis. Two groups, triple blind Analysis will be carried out with intent to treat and not inferiority with 95% confidence intervals

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Introduction:

By definition, 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. The authors 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 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 the authors 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 the authors found in which a percentage of success was estimated with the standard treatment of 7% compared to the experimental management of 11%, with a margin of no less than 5%, with an alpha for a tail of 0.05%, and a beta of 20 %, a total of 125 patients per group was obtained.

Statistical analysis:

Categorical values will be present as frequency and percentage, comparisons between groups will be done using the χ2 test for binary data or Fisher´s exact test. Continuous variables will be presented as means (SDs) or median and range interquartile range, if they meet normal criteria and will be compared using the Mann-Whitney U-test or t student test. p-Values of less than 0.05 will be considered significant. Statistical analyses will be performed using SPSS statistical software, version 25.0.0 (IBM corp). Analysis by intention to treat will be used. A Kaplan-Meier curve of the occurrence of incisional hernias stratified by treatment group will be plotted, and a long-rank test will be used to compare the hernia incidence between the groups

Study Type

Interventional

Enrollment (Actual)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Guanajuato
      • Leon, Guanajuato, Mexico, 37660
        • Hospital Regional de Alta Especialidad del Bajio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Procedure: Mesh reinforcement
Once the surgery is over. The closure is made with the 4: 1 rule, then an onlay mesh is placed that exceeds 3 cm on each side the wound is fixed with suture.
Other Names:
  • Prophylactic Mesh reinforcement
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
Procedure: RTL reinforcement
Once the surgery is finished, the ared is reinforced by placing a longitudinal suture parallel to the edge of the wound 0.5 cm, then the wound is closed with a 4: 1 rule but the suture enters lateral to the reinforcement suture
Other Names:
  • Technique RTL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with acute incisional hernia
Time Frame: 30 days
An abdominal wall gap with or without bulge in the area of the postoperative scar palpable bi clinical examination (yes or not)
30 days
Number of participants with Incisional hernia
Time Frame: 1 year
An abdominal wall gap with or without bulge in the area of the postoperative scar palpable bi clinical examination (yes or not)
1 year
Number of participants with Incisional hernia
Time Frame: 3 years
An abdominal wall gap with or without bulge in the area of the postoperative scar palpable bi clinical examination (yes or not)
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with surgical site infection
Time Frame: 30 days
Includes at least one of the following: (a) purulent drainage is present (culture documentation not required); (b) organisms are isolated from fluid/tissue of the superficial incision; (c) at least one sign of inflammation (eg, pain or tenderness, induration, erythema, local warmth of the wound) is present; (d) the wound is deliberately opened by the surgeon; (e) the surgeon or clinician declares the wound infected
30 days
abdominal pain postoperative
Time Frame: 5 days postoperative
It will be measured according to the visual analogue scale. Scale whose score goes from 0-10 being ten the maximum level expressed by the patient.
5 days postoperative
Number of participants with seroma
Time Frame: 10 days
presence of accumulation of clear body fluids in a place where the tissue has been removed by surgery, not associated with infection
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Regional de Alta Especialidad del Bajio

Investigators

  • Study Director: Jose de Jesus Alvarez Canales, Dr, Hospital Regional de Alta Especialidad del Bajio

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2022

Primary Completion (Actual)

January 30, 2022

Study Completion (Actual)

February 4, 2022

Study Registration Dates

First Submitted

October 8, 2019

First Submitted That Met QC Criteria

October 18, 2019

First Posted (Actual)

October 22, 2019

Study Record Updates

Last Update Posted (Actual)

February 28, 2022

Last Update Submitted That Met QC Criteria

February 9, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CI/HRAEB/2018/08
  • MeshVsRTL (Other Identifier: Hraeb)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Database available for analysis

IPD Sharing Time Frame

2 years

IPD Sharing Access Criteria

previous sending of email requesting it

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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