Prevention of Parastomal Hernia by Primary Mesh Insertion

This study has been terminated.
(Lack of recruitment from different study sites and due to structural changes in the included centers)
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 (Responsible Party):
Ismail Gögenur, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:
NCT00641342
First received: March 18, 2008
Last updated: February 6, 2014
Last verified: March 2008
  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: onlay 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:


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)
Arms Assigned Interventions
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

  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

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
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, Dr, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier: NCT00641342     History of Changes
Other Study ID Numbers: PMPC
Study First Received: March 18, 2008
Last Updated: February 6, 2014
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 April 17, 2014