Peristomal Mesh for Prophylaxis of Parastomal Hernia

Phase 3

Completed

• Conditions: Hernia

• 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

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-07-03
• Study First Submitted QC: 2007-07-03
• Study First Posted: 2007-07-04
• Primary Completion: 2011-09
• Study Completion: 2014-11
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-12
• Last Update Posted: 2015-01-14

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

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