NCT05939687

Prophylactic Mesh Placement During Stoma Closure After Low Anterior Resection

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 142 (estimated)
• Sponsor: Blokhin's Russian Cancer Research Center · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neoplasms Malignant
• Rectal Cancer
• Hernia Incisional
• Surgery

Interventions

Type	Name	Description
PROCEDURE	mesh	We'll use mesh repair for prevention of stoma-site hernias in the study group.
PROCEDURE	non-mesh	We'll use the layered ligature suturing of the abdominal wall without mesh implantation in the control group.

Timeline

• Start date: 2023-06-05
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2023-07-11
• Last updated: 2024-08-07

Locations

1 site across 1 country: Russia