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Prevention of Parastomal Hernia by Primary Mesh Insertion

This study is currently recruiting participants.
Verified March 2008 by University Hospital, Gentofte, Copenhagen
Sponsor:
Collaborators:
Aarhus University Hospital
Hvidovre University Hospital
Copenhagen University Hospital at Herlev
Sydvestjydsk sygehus, Esbjerg
Hillerod Hospital, Denmark
Vejle Hospital
Roskilde County Hospital
Information provided by:
University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:
NCT00641342
First received: March 18, 2008
Last updated: August 25, 2010
Last verified: March 2008
History of Changes
  Purpose

Approximately 1/3 of patients with a permanent end-colostomy will experience a hernia around the stoma. In some cases these problems result in the need of surgical correction and the risk of recurrent hernia after operative intervention is regrettably high. Preliminary investigations suggest a role for primary mesh placement to prevent parastomal hernia. The use of a mesh as a preventive measure is a safe procedure. This study will focus on the effect of primary mesh placement (two different operative procedures are used) compared to patients without mesh placement.


Condition Intervention Phase
Parastomal Hernia
 Device: mesh
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Parastomal Hernia by Primary Mesh Insertion: a Randomized Double-blinded Controlled Multi-centre Study.

Resource links provided by NLM:

MedlinePlus related topics: Hernia
U.S. FDA Resources

Further study details as provided by University Hospital, Gentofte, Copenhagen:

Primary Outcome Measures:
  • Parastomal hernia verified by CT-scan [ Time Frame: one year after surgery, reassessed after 2, 3 and 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinically detected parastomal hernia [ Time Frame: one year after surgery, reassessed after 2, 3 and 5 years ] [ Designated as safety issue: No ]
  • Pain [ Time Frame: one year after surgery, reassessed after 2, 3 and 5 years ] [ Designated as safety issue: No ]
  • Disease specific and general health questionnaire [ Time Frame: one year after surgery, reassessed after 2, 3 and 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 198
Study Start Date: March 2007
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: mesh
    StomaMesh (Precut heavyweight polypropylene mesh) Vypro Mesh (lightweight Prolene and vicryl mesh)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Permanent end-colostomy after surgery for rectosigmoid cancer with extirpation or Hartmann's procedure.

Exclusion Criteria:

  • ASA > 3
  • Acute surgery
  • Known immune deficiency
  • Surgery with insertion of foreign body (orthopaedic prosthesis, mechanical or bio-logical heart valve etc.) within the last 3 months.
  • Pregnancy
  • Known inflammatory bowel disease
  • Lack of written informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00641342

Contacts
Contact: Ismail Gögenur +45 3977 3390 ig@dadlnet.dk
Contact: Anders Fischer +45 3977 3977 anfi@geh.regionh.dk

Locations
Denmark
Copenhagen University Hospital, Hvidovre Recruiting
Hvidovre, Copebhagen, Denmark, 2630
Principal Investigator: Claus Buhl            
Copenhagen University Hospital, Gentofte Recruiting
Hellerup, Copenhagen, Denmark, 2900
Principal Investigator: Ismail Gögenur            
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
Aarhus University Hospital
Hvidovre University Hospital
Copenhagen University Hospital at Herlev
Sydvestjydsk sygehus, Esbjerg
Hillerod Hospital, Denmark
Vejle Hospital
Roskilde County Hospital
Investigators
Principal Investigator: Ismail Gögenur University Hospital of Copenhagen, GEntofte
  More Information

No publications provided

Responsible Party: Ismail Gögenur, MD, DmSc, University Hospital Gentofte, Copenhagen
ClinicalTrials.gov Identifier: NCT00641342     History of Changes
Other Study ID Numbers: PMPC
Study First Received: March 18, 2008
Last Updated: August 25, 2010
Health Authority: Denmark: National Board of Health

Keywords provided by University Hospital, Gentofte, Copenhagen:
Parastomal hernia
Onlay mesh
Sublay mesh
Pain
Health questionnaire

Additional relevant MeSH terms:
Hernia
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on June 17, 2013