Randomized Controlled Open Interventional Study for Evaluation of Use of Peristomal Mesh for Prophylaxis of Parastomal Hernia
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Hernia
- Sponsor
- Oslo University Hospital
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Parastomal hernia
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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
Investigators
Jan Lambrecht
MD
Oslo University Hospital
Eligibility Criteria
Inclusion Criteria
- •Condition with indication for establishing a permanent end-colostomy.
Exclusion Criteria
- •Age under 18
- •ASA score above 3
Outcomes
Primary Outcomes
Parastomal hernia
Time Frame: at 3, 12, 24, 36 and 48 months
Secondary Outcomes
- 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)