Peristomal Mesh for Prophylaxis of Parastomal Hernia - Full Text View

Sponsored by:	Rikshospitalet HF
Information provided by:	Rikshospitalet HF
ClinicalTrials.gov Identifier:	NCT00496418

Purpose

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

U.S. FDA Resources

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

Further study details as provided by Rikshospitalet HF:

Primary Outcome Measures:

Hernia postsurgery. [ Time Frame: at 3, 12, 24, 36 and 48 months ]

Secondary Outcome Measures:

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

Estimated Enrollment:	60
Study Start Date:	July 2007
Estimated Study Completion Date:	August 2013

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

Eligibility

Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00496418

Contacts

Contact: Jan Lambrecht, MD

+47 22934000

jan.lambrecht@rikshospitalet.no

Locations

Norway
Rikshospitalet-Radiumhospitalet HF	Recruiting
Oslo, Norway, NO-0027
Contact: Jan Lambrecht, MD
Principal Investigator: Jan Lambrecht, MD

Sponsors and Collaborators

Rikshospitalet HF

Investigators

Principal Investigator:

Jan Lambrecht, MD

Rikshospitalet-Radiumhospitalet HF, Medical Center

More Information

No publications provided

Study ID Numbers:	S-07203a
Study First Received:	July 3, 2007
Last Updated:	July 17, 2007
ClinicalTrials.gov Identifier:	NCT00496418 History of Changes
Health Authority:	Norway: Data Inspectorate

Keywords provided by Rikshospitalet HF:

colostomy
parastomal
peristomal
hernia

mesh
surgery
Indication for permanent end colostomy

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Hernia

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Hernia

ClinicalTrials.gov processed this record on May 07, 2009