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Prevention of Parastomal Hernia With a Mesh

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00509054
First Posted: July 31, 2007
Last Update Posted: April 16, 2008
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.
Information provided by:
Sundsvall Hospital
July 30, 2007
July 31, 2007
April 16, 2008
January 2001
June 2007   (Final data collection date for primary outcome measure)
Wound infection,mesh infection, parastomal hernia. [ Time Frame: Within five years ]
Same as current
Complete list of historical versions of study NCT00509054 on ClinicalTrials.gov Archive Site
Fistula formation, stenosis,pain. [ Time Frame: Within five years ]
Same as current
Not Provided
Not Provided
 
Prevention of Parastomal Hernia With a Mesh
Randomised Clinical Trial of the Use of a Prosthetic Mesh to Prevent Parastomal Hernia
Parastomal hernias are randomised to either a conventional stoma formed through the rectus anterior muscle or to the same procedure with the addition of a prophylactic mesh in a sublay position.

Parastomal hernias are randomised to either a conventional stoma formed through the rectus anterior muscle or to the same procedure with the addition of a prophylactic mesh in a sublay position. Randomisation is by opening closed envelopes.

A low-weight,partly absorbable mesh is used. Patients are followed for 5 years. Clinical follow up after one month to register early complications such as wound infection or mesh infection.

Clinical follow up after 12 months to register parastomal herniation, fistula formation, stenosis.

Clinical follow up after 5 years to register parastomal herniation, fistula formation, stenosis. At this clinical follow up radiologic examination is added.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Parastomal Hernia
Procedure: Prophylactic mesh
A low weigth partly absorbable mesh in a subaly posistion
Other Name: Vypro mesh, Ethicon.
Not Provided
Jänes A, Cengiz Y, Israelsson LA. Preventing parastomal hernia with a prosthetic mesh. Arch Surg. 2004 Dec;139(12):1356-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
July 2007
June 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinical need of an enterostoma

Exclusion Criteria:

  • Patients denies inclusion in the trial.
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
 
NCT00509054
Preventing parastomal hernia
Yes
Not Provided
Not Provided
Not Provided
Sundsvall Hospital
Not Provided
Study Director: Leif A Israelsson, MD,PhD Umea University
Sundsvall Hospital
January 2001

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