Mesh Reinforcement During Temporary Stoma Closure After Sphincter-Saving Rectal Cancer Surgery (MEMBO)

November 19, 2021 updated by: Assistance Publique - Hôpitaux de Paris

Mesh Reinforcement During Temporary Stoma Closure After Sphincter-Saving Rectal Cancer Surgery: A Randomized-controlled Trial

This study aim to assess long-term results of an incisional hernia-prophylactic mesh placement during stoma reversal after total mesorectal excision (TME) for rectal cancer

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study aim to assess long-term results of an incisional hernia-prophylactic mesh placement during stoma reversal after TME for rectal cancer.

Patients are randomized in 3 groups : no mesh, synthetic mesh (Parietex, Covidien), biologic mesh (Cellis, Meccelis). Meshes are placed in retromuscular position after diverting ileostomy closure.

Primary endpoint is radiological incisional hernia rate, assessed on CT-scan, at the end of follow-up Secondary endpoints include postoperative morbidity, postoperative pain, postoperative quality of life, long-term clinical incisional hernia rate.

Study Type

Interventional

Enrollment (Actual)

381

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • France
      • Clichy, France, 92118
        • Service de Chirurgie Colorectale - Hôpital Beaujon

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age > 18
  • Operated on for diverting ileostoma closure after sphincter saving rectal cancer surgery, irrespective of the time delay between ileostoma closure and rectal cancer surgery
  • Signed consent
  • Affiliation to the French social security system

Exclusion Criteria:

  • Emergency surgery
  • History of laparotomy before ileostoma closure.
  • Surgery associated to the ileostoma closure, excluding appendectomy or liver biopsy
  • Lactating or pregnant woman
  • Allergy to porcine product or collagen-based product. Allergy to polypropylene.
  • Participation to another protocol focusing on ileostoma closure

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Biologic Mesh
Biologic mesh placed in retromuscular position
Device: Biologic Mesh
Biologic mesh placed in retromuscular position during ileostoma closure
EXPERIMENTAL: Synthetic Mesh
Synthetic mesh placed in retromuscular position
Device: Synthetic Mesh
synthetic mesh placed in retromuscular position during ileostoma closure
NO_INTERVENTION: No Mesh
No mesh

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
radiological incisional hernia rate
Time Frame: up to 36 months

Primary endpoint is radiological incisional hernia rate, assessed on CT-scan, at the end of follow-up.

Statistical analysis will be performed as soon as follow-up reach 12 months for last included patient
up to 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative morbidity
Time Frame: 30 days
Postoperative morbidity
30 days
Postoperative pain
Time Frame: 36 months
Score Brief Pain Inventory
36 months
Postoperative rehospitalization
Time Frame: 36 months
Case report form data
36 months
Postoperative reintervention
Time Frame: 36 months
Case report form data
36 months
Quality of life (The Short Form (36) Health Survey score)
Time Frame: 12 months
The Short Form (36) Health Survey
12 months
Clinical incisional hernia rate
Time Frame: 36 months
Clinical incisional hernia rate : Statistical analysis will be performed as soon as follow-up reach 12 months for last included patient
36 months

Collaborators and Investigators

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

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Leon Maggiori, MD, Assistance Publique - Hôpitaux de Paris

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)

December 1, 2015

Primary Completion (ACTUAL)

November 15, 2020

Study Completion (ACTUAL)

November 15, 2020

Study Registration Dates

First Submitted

October 5, 2015

First Submitted That Met QC Criteria

October 14, 2015

First Posted (ESTIMATE)

October 15, 2015

Study Record Updates

Last Update Posted (ACTUAL)

November 22, 2021

Last Update Submitted That Met QC Criteria

November 19, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P140312
  • 2015-A00410-49 (OTHER: IDRCB)

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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