Prevention of Parastomal Hernia With a Mesh
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Official Title:||Randomised Clinical Trial of the Use of a Prosthetic Mesh to Prevent Parastomal Hernia|
- Wound infection,mesh infection, parastomal hernia. [ Time Frame: Within five years ]
- Fistula formation, stenosis,pain. [ Time Frame: Within five years ]
|Study Start Date:||January 2001|
|Study Completion Date:||July 2007|
|Primary Completion Date:||June 2007 (Final data collection date for primary outcome measure)|
Procedure: Prophylactic mesh
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00509054
|Kirurgkliniken Sundsvalls sjukhus|
|Sundsvall, Sweden, SE-85186|
|Study Director:||Leif A Israelsson, MD,PhD||Umea University|