Status:
COMPLETED
Evaluation of Bioresorbable Sheet to Prevent Intra-Abdominal Adhesions in Colorectal Surgeries
Lead Sponsor:
MAST Biosurgery, AG
Conditions:
Adhesions
Eligibility:
All Genders
18-78 years
Phase:
PHASE4
Brief Summary
Study to investigate and determine the difference between the extent and severity of intra-abdominal adhesions in patients where SurgiWrap film was placed compared to patients with no adhesion barrier...
Eligibility Criteria
Inclusion
- Patients with rectal cancer, ulcerative colitis or other pathologies requiring a second surgery for ileostomy closure.
- Age between 18 and 78 years.
- Patient or his/her legal representative has read and signed the approved Informed Consent form before randomization.
Exclusion
- Previous abdominal operation through a midline approach
- Use of hernia mesh
- Use of any antiadhesive irrigants or irrigants containing corticosteroids, heparin, salicylates, nonsteroidal anti-inflammatory drugs.
- Pregnancy
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00902148
Start Date
December 1 2003
End Date
March 1 2007
Last Update
May 15 2009
Active Locations (1)
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1
Akershus University Hospital
Lørenskog, Oslo County, Norway, N-0318