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

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Incisional Hernia After Diverting Stoma Closure

Treatments: Device: Biologic Mesh; Device: Synthetic Mesh

Study type: Interventional

Funder types: Other

Identifiers

NCT02576184

P140312

2015-A00410-49 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 381 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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381 participants in 3 patient groups

Biologic Mesh

Experimental group

Description:

Biologic mesh placed in retromuscular position

Treatment:

Device: Biologic Mesh

Synthetic Mesh

Experimental group

Description:

Synthetic mesh placed in retromuscular position

Treatment:

Device: Synthetic Mesh

No Mesh

No Intervention group

Description:

No mesh