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
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
381
Biologic mesh placed in retromuscular position during ileostoma closure
synthetic mesh placed in retromuscular position during ileostoma closure
Service de Chirurgie Colorectale - Hôpital Beaujon
Clichy, France
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
Time frame: up to 36 months
Postoperative morbidity
Postoperative morbidity
Time frame: 30 days
Postoperative pain
Score Brief Pain Inventory
Time frame: 36 months
Postoperative rehospitalization
Case report form data
Time frame: 36 months
Postoperative reintervention
Case report form data
Time frame: 36 months
Quality of life (The Short Form (36) Health Survey score)
The Short Form (36) Health Survey
Time frame: 12 months
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
Time frame: 36 months
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