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Prevention of Parastomal Hernia With a Mesh

This study has been completed.
Sponsor:
Information provided by:
Sundsvall Hospital
ClinicalTrials.gov Identifier:
NCT00509054
First received: July 30, 2007
Last updated: April 15, 2008
Last verified: January 2001
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Randomised Clinical Trial of the Use of a Prosthetic Mesh to Prevent Parastomal Hernia

Resource links provided by NLM:

MedlinePlus related topics: Hernia
U.S. FDA Resources

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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical need of an enterostoma

Exclusion Criteria:

  • Patients denies inclusion in the trial.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: July 30, 2007
Last Updated: April 15, 2008
Health Authority: Sweden: Regional Ethical Review Board

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

Additional relevant MeSH terms:
Hernia
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 19, 2013