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Prevention of Parastomal Hernia by Primary Mesh Insertion

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ClinicalTrials.gov Identifier: NCT00641342
Recruitment Status : Terminated (Lack of recruitment from different study sites and due to structural changes in the included centers)
First Posted : March 24, 2008
Last Update Posted : February 7, 2014
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Parastomal Hernia Device: onlay mesh Phase 2 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 198 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Parastomal Hernia by Primary Mesh Insertion: a Randomized Double-blinded Controlled Multi-centre Study.
Study Start Date : March 2007
Estimated Primary Completion Date : February 2015
Estimated Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: onlay mesh Device: onlay mesh
StomaMesh (Precut heavyweight polypropylene mesh) Vypro Mesh (lightweight Prolene and vicryl mesh)
Active Comparator: sublay mesh Device: onlay mesh
StomaMesh (Precut heavyweight polypropylene mesh) Vypro Mesh (lightweight Prolene and vicryl mesh)
No Intervention: no mesh


Outcome Measures

Primary Outcome Measures :
  1. Parastomal hernia verified by CT-scan [ Time Frame: one year after surgery, reassessed after 2, 3 and 5 years ]

Secondary Outcome Measures :
  1. Clinically detected parastomal hernia [ Time Frame: one year after surgery, reassessed after 2, 3 and 5 years ]
  2. Pain [ Time Frame: one year after surgery, reassessed after 2, 3 and 5 years ]
  3. Disease specific and general health questionnaire [ Time Frame: one year after surgery, reassessed after 2, 3 and 5 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): NCT00641342


Locations
Denmark
Copenhagen University Hospital, Hvidovre
Hvidovre, Copebhagen, Denmark, 2630
Copenhagen University Hospital, Gentofte
Hellerup, Copenhagen, Denmark, 2900
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
Aarhus University Hospital
Hvidovre University Hospital
Copenhagen University Hospital at Herlev
Sydvestjysk Hospital
Hillerod Hospital, Denmark
Vejle Hospital
Zealand University Hospital
Investigators
Principal Investigator: Ismail Gögenur University Hospital of Copenhagen, GEntofte
More Information

Responsible Party: Ismail Gögenur, Dr, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier: NCT00641342     History of Changes
Other Study ID Numbers: PMPC
First Posted: March 24, 2008    Key Record Dates
Last Update Posted: February 7, 2014
Last Verified: March 2008

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

Additional relevant MeSH terms:
Hernia
Pathological Conditions, Anatomical