A randomized control trial evaluating the effects of biologic mesh for the prevention of parastomal hernias in patients undergoing colostomy, ileostomy, ileal, colonic or conduits.
Not Applicable
- Conditions
- Parastomal HerniasPatients undergoing colostomy, ileostomy, ileal, colonic or conduitsSurgery - Surgical techniquesOral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
- Registration Number
- ACTRN12614000221651
- Lead Sponsor
- Dr. Peter Lee
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 76
Inclusion Criteria
Age 18 years or older; undergoing colostomy, ileostomy, or ileal or colonic conduits; Patients fit for surgery; Informed consent attained.
Exclusion Criteria
Age less than 18 years; patients who have previously had mesh inserted to the site of stoma formation or those who cannot have mesh inserted; no informed consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluate the development of parastomal hernia. Clinical and radiological evidence will be used to measure the primary outcome. [Patients will be followed up at 3, 6 12 months and 2 years post operation. ]
- Secondary Outcome Measures
Name Time Method Complication rate of biologic mesh. Known complications for this procedure include infection, mesh erosion into the bowel or stoma creating a fistula, hematoma, recurrence and adhesions. Clinical and radiological evidence will be used to measure the secondary outcome. [Patients will be followed up 3, 6 12 months and 2 years post operation.];Costs associated with the procedure, length of stay, and any subsequent care related to the procedure (including the cost of repairing a hernia post procedure) will be collected.[Patients will be followed up immediately, 3, 6 12 months and 2 years post operation.]