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Sponsored by: |
Rikshospitalet-Radiumhospitalet HF |
Information provided by: | Rikshospitalet-Radiumhospitalet HF |
ClinicalTrials.gov Identifier: | NCT00496418 |
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.
Condition | Intervention | Phase |
Hernia |
Device: Mesh in permanent colostomy |
Phase III |
MedlinePlus related topics: | Hernia |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Randomized Controlled Open Interventional Study for Evaluation of Use of Peristomal Mesh for Prophylaxis of Parastomal Hernia |
Estimated Enrollment: | 60 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | August 2013 |
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
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jan Lambrecht, MD | +47 22934000 | jan.lambrecht@rikshospitalet.no |
Norway | |||||
Rikshospitalet-Radiumhospitalet HF | Recruiting | ||||
Oslo, Norway, NO-0027 | |||||
Contact: Jan Lambrecht, MD | |||||
Principal Investigator: Jan Lambrecht, MD |
Rikshospitalet-Radiumhospitalet HF |
Principal Investigator: | Jan Lambrecht, MD | Rikshospitalet-Radiumhospitalet HF, Medical Center |
Study ID Numbers: | S-07203a |
First Received: | July 3, 2007 |
Last Updated: | July 17, 2007 |
ClinicalTrials.gov Identifier: | NCT00496418 |
Health Authority: | Norway: Data Inspectorate |
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