Trial Information
Randomized, Controlled, Prospective Study of the Use of a Mesh to Prevent Parastomal Hernia
Inclusion Criteria:
- patients scheduled for permanent end colostomy to treat cancer of the lower third of
the rectum,
- Aged over 18,
- Charlson comorbidity index below 7
- Elective surgery
- Radical surgery
Exclusion Criteria:
- Loop colostomies,
- Emergency surgery,
- Body mass index above 35 kg/sq.m.,
- Palliative surgery,
- Hepatic cirrhosis,
- Severe COPD (requiring home oxygen treatment),
- Corticoid treatment
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
the reduction in the incidence of Parastomal Hernia after the mesh placement
Outcome Time Frame:
6 months
Principal Investigator
Salvador Navarro-Soto, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Corporacio Sanitaria Parc Tauli
Authority:
Spain: Ethics Committee
Study ID:
CSPT-SerraA-01
NCT ID:
NCT00691860
Start Date:
April 2006
Completion Date:
February 2008
Related Keywords:
- Parastomal Hernia
- Parastomal hernias
- Tolerance of lightweight meshes
- Paracolostomy hernias
- Peristomal hernias
- Hernia