Prevention of Parastomal Hernia With a Mesh
|ClinicalTrials.gov Identifier: NCT00509054|
Recruitment Status : Completed
First Posted : July 31, 2007
Last Update Posted : April 16, 2008
|Condition or disease||Intervention/treatment||Phase|
|Parastomal Hernia||Procedure: Prophylactic mesh||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||54 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Randomised Clinical Trial of the Use of a Prosthetic Mesh to Prevent Parastomal Hernia|
|Study Start Date :||January 2001|
|Actual Primary Completion Date :||June 2007|
|Actual Study Completion Date :||July 2007|
- Procedure: Prophylactic mesh
A low weigth partly absorbable mesh in a subaly posistionOther Name: Vypro mesh, Ethicon.
- Wound infection,mesh infection, parastomal hernia. [ Time Frame: Within five years ]
- Fistula formation, stenosis,pain. [ Time Frame: Within five years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00509054
|Kirurgkliniken Sundsvalls sjukhus|
|Sundsvall, Sweden, SE-85186|
|Study Director:||Leif A Israelsson, MD,PhD||Umea University|