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

Primary Purpose

Incisional Hernia After Diverting Stoma Closure

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Biologic Mesh
Synthetic Mesh
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Incisional Hernia After Diverting Stoma Closure focused on measuring Incisional hernia, Stoma, rectal cancer, synthetic mesh, biologic mesh

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Service de Chirurgie Colorectale - Hôpital Beaujon

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Biologic Mesh

Synthetic Mesh

No Mesh

Arm Description

Biologic mesh placed in retromuscular position

Synthetic mesh placed in retromuscular position

No mesh

Outcomes

Primary Outcome Measures

radiological incisional hernia rate
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

Secondary Outcome Measures

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

Full Information

First Posted
October 5, 2015
Last Updated
November 19, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT02576184
Brief Title
Mesh Reinforcement During Temporary Stoma Closure After Sphincter-Saving Rectal Cancer Surgery
Acronym
MEMBO
Official Title
Mesh Reinforcement During Temporary Stoma Closure After Sphincter-Saving Rectal Cancer Surgery: A Randomized-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
December 2015 (Actual)
Primary Completion Date
November 15, 2020 (Actual)
Study Completion Date
November 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Incisional Hernia After Diverting Stoma Closure
Keywords
Incisional hernia, Stoma, rectal cancer, synthetic mesh, biologic mesh

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Biologic mesh Synthetic mesh
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
381 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Biologic Mesh
Arm Type
Experimental
Arm Description
Biologic mesh placed in retromuscular position
Arm Title
Synthetic Mesh
Arm Type
Experimental
Arm Description
Synthetic mesh placed in retromuscular position
Arm Title
No Mesh
Arm Type
No Intervention
Arm Description
No mesh
Intervention Type
Device
Intervention Name(s)
Biologic Mesh
Intervention Description
Biologic mesh placed in retromuscular position during ileostoma closure
Intervention Type
Device
Intervention Name(s)
Synthetic Mesh
Intervention Description
synthetic mesh placed in retromuscular position during ileostoma closure
Primary Outcome Measure Information:
Title
radiological incisional hernia rate
Description
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
Time Frame
up to 36 months
Secondary Outcome Measure Information:
Title
Postoperative morbidity
Description
Postoperative morbidity
Time Frame
30 days
Title
Postoperative pain
Description
Score Brief Pain Inventory
Time Frame
36 months
Title
Postoperative rehospitalization
Description
Case report form data
Time Frame
36 months
Title
Postoperative reintervention
Description
Case report form data
Time Frame
36 months
Title
Quality of life (The Short Form (36) Health Survey score)
Description
The Short Form (36) Health Survey
Time Frame
12 months
Title
Clinical incisional hernia rate
Description
Clinical incisional hernia rate : Statistical analysis will be performed as soon as follow-up reach 12 months for last included patient
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leon Maggiori, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Chirurgie Colorectale - Hôpital Beaujon
City
Clichy
ZIP/Postal Code
92118
Country
France

12. IPD Sharing Statement

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

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