Trial Information
Randomized, Controlled, Prospective Study of the Use of a Mesh to Prevent Parastomal Hernia After Laparoscopic Abdominoperineal Resection
Inclusion Criteria:
- Patients of either sex intervened electively for colorectal surgery (rectal cancer)
in whom definitive colostomy is indicated after laparoscopic abdominoperineal
amputation.
- Life expectancy above 12 months
Exclusion Criteria:
- - Patients with allergy or intolerance of the compounds in the mesh
- Carriers of prosthetic meshes in the area of the ostomy
- Patients electively intervened for colorectal surgery (neo de reco) in whom
definitive colostomy is indicated after abdominoperineal amputation but not via a
laparoscopic approach.
- Cirrhotic patients
- Patients with life expectancy below 12 months due to underlying disease
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/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:
12 months
Safety Issue:
Yes
Principal Investigator
Xavier Serra-Aracil, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Corporacion Sanitaria Universitaria Parc Tauli
Authority:
Spain: Comité Ético de Investigación Clínica
Study ID:
LAP-APR-2012-028
NCT ID:
NCT01722565
Start Date:
January 2012
Completion Date:
June 2014
Related Keywords:
- Parastomal Hernia
- Parastomal hernias
- Tolerance of lightweight meshes
- laparoscopic abdominoperineal resection
- Hernia