NCT00496418

Peristomal Mesh for Prophylaxis of Parastomal Hernia

Randomized Controlled Open Interventional Study for Evaluation of Use of Peristomal Mesh for Prophylaxis of Parastomal Hernia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Conditions

• Hernia

Interventions

Type	Name	Description
DEVICE	Mesh in permanent colostomy

Timeline

• Start date: 2007-07-01
• Primary completion: 2011-09-01
• Completion: 2014-11-01
• First posted: 2007-07-04
• Last updated: 2015-01-14

Locations

1 site across 1 country: Norway