Peristomal Mesh for Prophylaxis of Parastomal Hernia

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jan Lambrecht, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00496418
First received: July 3, 2007
Last updated: January 25, 2013
Last verified: January 2013

July 3, 2007
January 25, 2013
July 2007
September 2011   (final data collection date for primary outcome measure)
Parastomal hernia [ Time Frame: at 3, 12, 24, 36 and 48 months ] [ Designated as safety issue: No ]
Hernia postsurgery. [ Time Frame: at 3, 12, 24, 36 and 48 months ]
Complete list of historical versions of study NCT00496418 on ClinicalTrials.gov Archive Site
Operating time, infection, obstruction, stenosis, retraction, fistulae, skin related problems and reoperations. Endpoints are correlated to body mass index, previous hernia, age, concurrent illness and cause for colostomy [ Time Frame: 4 years ] [ Designated as safety issue: No ]
Operating time, infection, obstruction, stenosis, retraction, fistulae, skin related problems and reoperations. Endpoints are correlated to body mass index, previous hernia, age, concurrent illness and cause for colostomy
Not Provided
Not Provided
 
Peristomal Mesh for Prophylaxis of Parastomal Hernia
Randomized Controlled Open Interventional Study for Evaluation of Use of Peristomal Mesh for Prophylaxis of Parastomal Hernia

The study aims to prove differences or equalities in outcome for patients operated with or without a peristomal mesh in the sublay position when establishing a permanent colostomy.

Patients are randomized to 2 groups equal in number: a group with mesh implantation and a control group without mesh implantation.

Primary endpoint is Parastomal hernia. Secondary endpoints are operating time, infection, obstruction, stenosis, retraction, fistulae, skin related problems and reoperations. Endpoints are correlated to body mass index, previous hernia, age, concurrent illness and cause for colostomy. Patients are followed 4 years after operation with clinical examination

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hernia
Device: Mesh in permanent colostomy
  • Experimental: Prophylactic stoma mesh
    Mesh
    Intervention: Device: Mesh in permanent colostomy
  • Active Comparator: No mesh prophylaxis
    No mesh
    Intervention: Device: Mesh in permanent colostomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
September 2015
September 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Condition with indication for establishing a permanent end-colostomy.

Exclusion Criteria:

  • Age under 18
  • ASA score above 3
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00496418
S-07203a
Not Provided
Jan Lambrecht, Oslo University Hospital
Oslo University Hospital
Not Provided
Principal Investigator: Jan Lambrecht, MD Rikshospitalet-Radiumhospitalet HF, Medical Center
Oslo University Hospital
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP