Status:
TERMINATED
Prevention of Parastomal Hernia by Primary Mesh Insertion
Lead Sponsor:
University Hospital, Gentofte, Copenhagen
Collaborating Sponsors:
Aarhus University Hospital
Hvidovre University Hospital
Conditions:
Parastomal Hernia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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...
Eligibility Criteria
Inclusion
- Permanent end-colostomy after surgery for rectosigmoid cancer with extirpation or Hartmann's procedure.
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2015
Estimated Enrollment :
198 Patients enrolled
Trial Details
Trial ID
NCT00641342
Start Date
March 1 2007
End Date
February 1 2015
Last Update
February 7 2014
Active Locations (2)
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1
Copenhagen University Hospital, Hvidovre
Hvidovre, Copebhagen, Denmark, 2630
2
Copenhagen University Hospital, Gentofte
Hellerup, Copenhagen, Denmark, 2900