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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
  Purpose
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.

Condition Intervention Phase
Parastomal Hernia Procedure: Prophylactic mesh Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Randomised Clinical Trial of the Use of a Prosthetic Mesh to Prevent Parastomal Hernia

Resource links provided by NLM:


Further study details as provided by Sundsvall Hospital:

Primary Outcome Measures:
  • Wound infection,mesh infection, parastomal hernia. [ Time Frame: Within five years ]

Secondary Outcome Measures:
  • Fistula formation, stenosis,pain. [ Time Frame: Within five years ]

Estimated Enrollment: 54
Study Start Date: January 2001
Study Completion Date: July 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Prophylactic mesh
    A low weigth partly absorbable mesh in a subaly posistion
    Other Name: Vypro mesh, Ethicon.
Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical need of an enterostoma

Exclusion Criteria:

  • Patients denies inclusion in the trial.
  Contacts and Locations
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): NCT00509054


Locations
Sweden
Kirurgkliniken Sundsvalls sjukhus
Sundsvall, Sweden, SE-85186
Sponsors and Collaborators
Sundsvall Hospital
Investigators
Study Director: Leif A Israelsson, MD,PhD Umea University
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00509054     History of Changes
Other Study ID Numbers: Preventing parastomal hernia
First Submitted: July 30, 2007
First Posted: July 31, 2007
Last Update Posted: April 16, 2008
Last Verified: January 2001

Keywords provided by Sundsvall Hospital:
Parastomal hernia, wound infection, stoma care.

Additional relevant MeSH terms:
Hernia
Pathological Conditions, Anatomical