ProMeLAR: Prophylactic Mesh Placement During Stoma Closure After Low Anterior Resection

Sponsor

Blokhin's Russian Cancer Research Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05939687

Collaborator

(none)

142

Enrollment

Location

Arms

65.9

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neoplasms Malignant Rectal Cancer Hernia Incisional Surgery	Procedure: mesh Procedure: non-mesh	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

142 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

1:1 electronic randomisation1:1 electronic randomisation

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jun 5, 2023

Anticipated Primary Completion Date :

Dec 1, 2028

Anticipated Study Completion Date :

Dec 1, 2028

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

hernia rate [2 years]
The rate of parastomal hernias after stoma closure for 2 years.

Secondary Outcome Measures

90 day surgical morbidity [90 days]
Complications after stoma closure including hernias
Quality of life [2 years]
Quality of life measured by the HerQLes (Hernia-Related Quality of Life Survey) scale at 30 days, 1 year and 2 years after stoma closure

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	N.N.Blokhin Russian Cancer Research Center	Moscow		Russian Federation	115478

Sponsors and Collaborators

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