Randomised Clinical Trial of the Use of a Prosthetic Mesh to Prevent Parastomal Hernia
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 54
- Locations
- 2
- Primary Endpoint
- Wound infection,mesh infection, parastomal hernia.
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Clinical need of an enterostoma
Exclusion Criteria
- •Patients denies inclusion in the trial.
Outcomes
Primary Outcomes
Wound infection,mesh infection, parastomal hernia.
Time Frame: Within five years
Secondary Outcomes
- Fistula formation, stenosis,pain.(Within five years)