Prophylactic Mesh Placement During Stoma Closure After Low Anterior Resection (ProMeLAR)

August 6, 2024 updated by: Sergey Gordeyev, Blokhin's Russian Cancer Research Center

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

142

Phase

  • Phase 3

Contacts and Locations

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

Study Contact

Study Locations

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hernia rate
Time Frame: 2 years
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
Time Frame: 90 days
Complications after stoma closure including hernias
90 days
Quality of life indicators by HerQLes scale
Time Frame: 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)
2 years

Collaborators and Investigators

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

Sponsor

Blokhin's Russian Cancer Research Center

Investigators

  • Study Director: Zaman Z Mamedli, PhD, N.N.Blokhin Russian Cancer Research Center
  • Study Chair: Nikolay L Matveev, PhD, Pirogov Russian National Research Medical University

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)

June 5, 2023

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

July 3, 2023

First Submitted That Met QC Criteria

July 3, 2023

First Posted (Actual)

July 11, 2023

Study Record Updates

Last Update Posted (Actual)

August 7, 2024

Last Update Submitted That Met QC Criteria

August 6, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ProMeLAR-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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