Skip to main content
OpenTrials
Completed

NCT Number: NCT02576184

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Incisional Hernia After Diverting Stoma Closure Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Hernia Incisional Hernia Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications Rectal Diseases Rectal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de Chirurgie Colorectale - Hôpital Beaujon

Clichy, 92118, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biologic Mesh

Device

Biologic mesh placed in retromuscular position during ileostoma closure

Synthetic Mesh

Device

synthetic mesh placed in retromuscular position during ileostoma closure

Primary outcomes

  1. 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

Secondary outcomes

  1. Postoperative morbidity

    Time frame: 30 days

    Postoperative morbidity

  2. Postoperative pain

    Time frame: 36 months

    Score Brief Pain Inventory

  3. Postoperative rehospitalization

    Time frame: 36 months

    Case report form data

  4. Postoperative reintervention

    Time frame: 36 months

    Case report form data

  5. Quality of life (The Short Form (36) Health Survey score)

    Time frame: 12 months

    The Short Form (36) Health Survey

  6. 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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: MEMBO

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Oct 15, 2015
Registry last updated
Nov 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.