NCT00509054

Prevention of Parastomal Hernia With a Mesh

Randomised Clinical Trial of the Use of a Prosthetic Mesh to Prevent Parastomal Hernia

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Sundsvall Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Parastomal Hernia

Interventions

Type	Name	Description
PROCEDURE	Prophylactic mesh	A low weigth partly absorbable mesh in a subaly posistion

Timeline

• Start date: 2001-01-01
• Primary completion: 2007-06-01
• Completion: 2007-07-01
• First posted: 2007-07-31
• Last updated: 2008-04-16

Locations

1 site across 1 country: Sweden