Mesh Reinforcement During Temporary Stoma Closure After Sphincter-Saving Rectal Cancer Surgery: A Randomized-controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 381
- Locations
- 1
- Primary Endpoint
- radiological incisional hernia rate
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Synthetic Mesh
Synthetic mesh placed in retromuscular position
Intervention: Synthetic Mesh (Device)
Biologic Mesh
Biologic mesh placed in retromuscular position
Intervention: Biologic Mesh (Device)
No Mesh
No mesh
Outcomes
Primary Outcomes
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
- Postoperative morbidity(30 days)
- Postoperative pain(36 months)
- Postoperative rehospitalization(36 months)
- Postoperative reintervention(36 months)
- Clinical incisional hernia rate(36 months)
- Quality of life (The Short Form (36) Health Survey score)(12 months)