Prophylactic Mesh Placement During Stoma Closure After Low Anterior Resection

Phase 3

Recruiting

• Conditions: Neoplasms Malignant; Rectal Cancer; Hernia Incisional; Surgery
• Interventions: Procedure: mesh; Procedure: non-mesh

• Registration Number: NCT05939687
• Lead Sponsor: Blokhin's Russian Cancer Research Center

Brief Summary

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

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.

Study Timeline

• Study Start: 2023-06-05
• Study First Submitted: 2023-07-03
• Study First Submitted QC: 2023-07-03
• Study First Posted: 2023-07-11
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-06
• Last Update Posted: 2024-08-07
• Primary Completion: 2028-12-01
• Study Completion: 2028-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 142

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mesh	mesh	In these patients we will do sublay/interoblique repair for prevention of stoma-site hernias using a polypropylene mesh.
non-mesh	non-mesh	In these patients we will close the stoma with standard layered ligature suturing of the abdominal wall without mesh implantation.

Primary Outcome Measures

Name	Time	Method
hernia rate	2 years	The rate of parastomal hernias after stoma closure for 2 years.

Secondary Outcome Measures

Name	Time	Method
Quality of life indicators by HerQLes scale	2 years	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)
90 day surgical morbidity	90 days	Complications after stoma closure including hernias

Trial Locations

Locations (1)

N.N.Blokhin Russian Cancer Research Center; 🇷🇺 Moscow, Russian Federation