Prophylactic Mesh Placement During Stoma Closure After Low Anterior Resection

Surgery Clinical Trial

— ProMeLAR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05939687
• Other study ID #: ProMeLAR-01
• Status: Recruiting
• Phase: Phase 3
• Start date: June 5, 2023
• Est. completion date: December 1, 2028

Study information

• Verified date: July 2023
• Source: Blokhin's Russian Cancer Research Center
• Contact: Sergey Gordeyev, D.Sc.
• Phone: 9104501213
• Email: ss.netoncology[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 142
• Est. completion date: December 1, 2028
• Est. primary completion date: December 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia Incisional
• Incisional Hernia
• Neoplasms
• Neoplasms Malignant
• Rectal Cancer
• Rectal Neoplasms
• Surgery

Intervention

Procedure:
• mesh
We'll use mesh repair for prevention of stoma-site hernias in the study group.
• non-mesh
We'll use the layered ligature suturing of the abdominal wall without mesh implantation in the control group.

Locations

Country	Name	City	State
Russian Federation	N.N.Blokhin Russian Cancer Research Center	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Blokhin's Russian Cancer Research Center

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hernia rate	The rate of parastomal hernias after stoma closure for 2 years.	2 years
Secondary	90 day surgical morbidity	Complications after stoma closure including hernias	90 days
Secondary	Quality of life indicators by HerQLes scale	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