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Prophylactic Mesh Placement During Stoma Closure After Low Anterior Resection

NCT05939687 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2024-08-07

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Blokhin's Russian Cancer Research Center

    lead OTHER

Principal Investigators

  • Zaman Z Mamedli, PhD · N.N.Blokhin Russian Cancer Research Center

  • Nikolay L Matveev, PhD · Pirogov Russian National Research Medical University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-05
Primary Completion
2028-12-01
Completion
2028-12-01

Countries

  • Russia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05939687 on ClinicalTrials.gov