Status:
WITHDRAWN
Study of a New Laparoscopic Technique for Parastomal Hernia Repair With Mesh
Lead Sponsor:
University Hospital, Gentofte, Copenhagen
Collaborating Sponsors:
Ethicon, Inc.
Conditions:
Hernia
Abdominal Hernia
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The purpose of the study is to evaluate a new laparoscopic technique for parastomal hernia repair using an intraperitoneally placed Proceed mesh, looking at postoperative complications, recurrence rat...
Detailed Description
Parastomal hernia affects up to 50% of all patients following formation of a stoma, most often in patients with a colostomy. About 20% of the patients need surgical correction of their parastomal hern...
Eligibility Criteria
Inclusion
- Age 18 - 80 years
- Indication for laparoscopic parastomal hernia repair in general anaesthesia.
- Danish speaking
- ASA group I-III
- No remaining malignancy after former primary radical operation for colorectal cancer
Exclusion
- Former operation (open/lap) for parastomal hernia with insertion of mesh, or other mesh operation in the area of herniation
- Incarcerated hernia (acute operation)
- History of abuse or permanent morphine use
- Expected bad compliance
- Current systemic steroid use or other immuno-suppressive treatment
- HIV-positive, pregnant or breast feeding
- Medical conditions contraindicating general anaesthesia
- Simultaneous operation for other ventral, inguinal or umbilical hernia
- Epidural or spinal anaesthesia
- Conversion to open procedure
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2007
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00138957
Start Date
September 1 2005
End Date
December 1 2007
Last Update
July 11 2008
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