Peristomal Mesh for Prophylaxis of Parastomal Hernia
Phase 3
Completed
- Conditions
- Hernia
- Interventions
- Device: Mesh in permanent colostomy
- Registration Number
- NCT00496418
- Lead Sponsor
- Oslo University Hospital
- Brief Summary
The study aims to prove differences or equalities in outcome for patients operated with or without a peristomal mesh in the sublay position when establishing a permanent colostomy.
- Detailed Description
Patients are randomized to 2 groups equal in number: a group with mesh implantation and a control group without mesh implantation.
Primary endpoint is Parastomal hernia. Secondary endpoints are operating time, infection, obstruction, stenosis, retraction, fistulae, skin related problems and reoperations. Endpoints are correlated to body mass index, previous hernia, age, concurrent illness and cause for colostomy. Patients are followed 4 years after operation with clinical examination
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
- Condition with indication for establishing a permanent end-colostomy.
Exclusion Criteria
- Age under 18
- ASA score above 3
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Prophylactic stoma mesh Mesh in permanent colostomy Mesh No mesh prophylaxis Mesh in permanent colostomy No mesh
- Primary Outcome Measures
Name Time Method Parastomal hernia at 3, 12, 24, 36 and 48 months
- Secondary Outcome Measures
Name Time Method Operating time, infection, obstruction, stenosis, retraction, fistulae, skin related problems and reoperations. Endpoints are correlated to body mass index, previous hernia, age, concurrent illness and cause for colostomy 4 years
Trial Locations
- Locations (1)
Rikshospitalet-Radiumhospitalet HF
🇳🇴Oslo, Norway