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Peristomal Mesh for Prophylaxis of Parastomal Hernia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00496418
Recruitment Status : Completed
First Posted : July 4, 2007
Last Update Posted : January 14, 2015
Sponsor:
Information provided by (Responsible Party):
Jan Lambrecht, Oslo University Hospital

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Hernia Device: Mesh in permanent colostomy Phase 3

Detailed Description:

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Open Interventional Study for Evaluation of Use of Peristomal Mesh for Prophylaxis of Parastomal Hernia
Study Start Date : July 2007
Actual Primary Completion Date : September 2011
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arms and Interventions
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Arm Intervention/treatment
Experimental: Prophylactic stoma mesh
Mesh
 Device: Mesh in permanent colostomy
Active Comparator: No mesh prophylaxis
No mesh
 Device: Mesh in permanent colostomy


Outcome Measures
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Primary Outcome Measures :
  1. Parastomal hernia [ Time Frame: at 3, 12, 24, 36 and 48 months ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Age under 18
  • ASA score above 3
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00496418


Locations
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Norway
Rikshospitalet-Radiumhospitalet HF
Oslo, Norway, NO-0027
Sponsors and Collaborators
Oslo University Hospital
Investigators
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Principal Investigator: Jan Lambrecht, MD Rikshospitalet-Radiumhospitalet HF, Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jan Lambrecht, MD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT00496418    
Other Study ID Numbers: S-07203a
First Posted: July 4, 2007    Key Record Dates
Last Update Posted: January 14, 2015
Last Verified: January 2015
Keywords provided by Jan Lambrecht, Oslo University Hospital:
colostomy
parastomal
peristomal
hernia
 mesh
surgery
Indication for permanent end colostomy
Additional relevant MeSH terms:
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Hernia
Pathological Conditions, Anatomical