Prevention of Parastomal Hernia With a Mesh

Status Completed

Clinical Trial Summary

Parastomal hernias are randomised to either a conventional stoma formed through the rectus anterior muscle or to the same procedure with the addition of a prophylactic mesh in a sublay position.

Clinical Trial Description

Parastomal hernias are randomised to either a conventional stoma formed through the rectus anterior muscle or to the same procedure with the addition of a prophylactic mesh in a sublay position. Randomisation is by opening closed envelopes.

A low-weight,partly absorbable mesh is used. Patients are followed for 5 years. Clinical follow up after one month to register early complications such as wound infection or mesh infection.

Clinical follow up after 12 months to register parastomal herniation, fistula formation, stenosis.

Clinical follow up after 5 years to register parastomal herniation, fistula formation, stenosis. At this clinical follow up radiologic examination is added. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00509054
Study type	Interventional
Source	Sundsvall Hospital
Contact
Status	Completed
Phase	Phase 4
Start date	January 2001
Completion date	July 2007

View Details

See also
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