Prophylactic Mesh Placement During Stoma Closure After Low Anterior Resection

Study Overview
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Brief Summary
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The goal of this clinical trial is to compare the efficacy of using polypropylene mesh for hernia prevention after stoma closure in patients with colorectal cancer and non-mesh repair. The main question it aims to answer is: can mesh help prevent hernia? Participants will be divided into 2 groups: with and without mesh using. They must be followed up for 2 years after enrollment in the study. Researchers will compare mesh and non-mesh groups to evaluate the benefits and harms of mesh using in hernia prevention.

Detailed Description
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This clinical trial is prospective randomized phase III study of the efficacy of polypropylene mesh for hernia prevention after stoma closure in patients with colorectal cancer. We will include in the study group 71 patients with colorectal cancer with ileo- and colostomy. In these patients we will do sublay/interoblique repair in prevention incisional hernias using polypropylene mesh. Our hypothesis is to reduce parastomal hernias rate from 30% to 10% over 2 years. Stratification will be used for patients with >5 cm vs <5 cm stoma-site hernia. The control group will include 71 patients with similar parameters who will undergo stoma closure with layered ligature suturing of the abdominal wall without mesh implantation. Additional endpoints are the wound infection rate, the complication rate (Clavien-Dindo), the rate of the repeated surgery for hernia at the site of stoma closure. We'll assess the quality of life by HerQLes (Hernia-Related Quality of Life Survey) scale.

Official Title
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Prophylactic Mesh Placement During Temporary Stoma Closure: a Prospective Randomized Phase III Clinical Trial

Conditions
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Rectal Cancer, Neoplasms Malignant, Hernia Incisional, Surgery

Intervention / Treatment
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* Procedure: mesh
* Procedure: non-mesh


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent Absence of distant metastases (M0) ECOG (Eastern Cooperative Oncology Group) status 0-2 completed course of adjuvant treatment Absence of acute inflammatory parastomal complications Integrity of colorectal anastomosis Exclusion Criteria: Inability to obtain consent to participate Synchronous and metachronous malignant neoplasms Clinically significant diseases of the cardiovascular system, liver, kidney, central nervous system Parastomal inflammation and other conditions that increase the risk of postoperative complications Pregnancy HIV infection

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 1:1 electronic randomisation
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mesh<br>In these patients we will do sublay/interoblique repair for prevention of stoma-site hernias using a polypropylene mesh. | Procedure: mesh<br>* We'll use mesh repair for prevention of stoma-site hernias in the study group.<br>* Other names: polypropylene mesh;|
| Active Comparator: non-mesh<br>In these patients we will close the stoma with standard layered ligature suturing of the abdominal wall without mesh implantation. | Procedure: non-mesh<br>* We'll use the layered ligature suturing of the abdominal wall without mesh implantation in the control group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hernia rate | The rate of parastomal hernias after stoma closure for 2 years. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 90 day surgical morbidity | Complications after stoma closure including hernias | 90 days | 
| Quality of life indicators by HerQLes scale | Quality of life as assessed by Hernia-Related Quality of Life Survey scale (HerQLes) at 30 days, 1 year and 2 years after stoma closure (higher scores are worse) | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rectal cancer, mesh, stoma-site hernia, prevention, surgery