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

Not Applicable

Completed

• Conditions: Incisional Hernia After Diverting Stoma Closure
• Interventions: Device: Biologic Mesh; Device: Synthetic Mesh

• Registration Number: NCT02576184
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2015-10-05
• Study First Submitted QC: 2015-10-14
• Study First Posted: 2015-10-15
• Study Start: 2015-12
• Primary Completion: 2020-11-15
• Study Completion: 2020-11-15
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-19
• Last Update Posted: 2021-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 381

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Biologic Mesh	Biologic Mesh	Biologic mesh placed in retromuscular position
Synthetic Mesh	Synthetic Mesh	Synthetic mesh placed in retromuscular position

Primary Outcome Measures

Name	Time	Method
radiological incisional hernia rate	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 Outcome Measures

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

Trial Locations

Locations (1)

Service de Chirurgie Colorectale - Hôpital Beaujon; 🇫🇷 Clichy, France