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Prevention of Parastomal Hernia With a Mesh

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ClinicalTrials.gov Identifier: NCT00509054
Recruitment Status : Completed
First Posted : July 31, 2007
Last Update Posted : April 16, 2008
Sponsor:
Information provided by:
Sundsvall Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Parastomal Hernia Procedure: Prophylactic mesh Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
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
Study Start Date : January 2001
Actual Primary Completion Date : June 2007
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia


Intervention Details:
  • Procedure: Prophylactic mesh
    A low weigth partly absorbable mesh in a subaly posistion
    Other Name: Vypro mesh, Ethicon.


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

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


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
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.

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

Publications of Results:
ClinicalTrials.gov Identifier: NCT00509054     History of Changes
Other Study ID Numbers: Preventing parastomal hernia
First Posted: July 31, 2007    Key Record Dates
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