NCT00641342

Prevention of Parastomal Hernia by Primary Mesh Insertion

Prevention of Parastomal Hernia by Primary Mesh Insertion: a Randomized Double-blinded Controlled Multi-centre Study.

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 198 (estimated)
• Sponsor: University Hospital, Gentofte, Copenhagen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Approximately 1/3 of patients with a permanent end-colostomy will experience a hernia around the stoma. In some cases these problems result in the need of surgical correction and the risk of recurrent hernia after operative intervention is regrettably high. Preliminary investigations suggest a role for primary mesh placement to prevent parastomal hernia. The use of a mesh as a preventive measure is a safe procedure. This study will focus on the effect of primary mesh placement (two different operative procedures are used) compared to patients without mesh placement.

Conditions

• Parastomal Hernia

Interventions

Type	Name	Description
DEVICE	onlay mesh	StomaMesh (Precut heavyweight polypropylene mesh) Vypro Mesh (lightweight Prolene and vicryl mesh)

Timeline

• Start date: 2007-03-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2008-03-24
• Last updated: 2014-02-07

Locations

2 sites across 1 country: Denmark