Status:
COMPLETED
Seprafilm in the Reduction of Incidence of Bowel Obstruction in General Surgery
Lead Sponsor:
Genzyme, a Sanofi Company
Conditions:
Intestinal Obstruction
Digestive System Surgical Procedures
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
The purpose of the study is to evaluate the efficacy of Seprafilm in reducing the incidence of bowel obstruction and to evaluate the incidence of all serious adverse events (SAEs) associated with the ...
Eligibility Criteria
Inclusion
- Patients who were undergoing colon and/or rectal resections and/or adhesiolysis for treatment of bowel obstruction
Exclusion
- Patients with any medical condition or disease where 5-year survival was not expected
- Patients undergoing laparoscopy
- Patients undergoing surgery for treatment of acute abdominal trauma
- Patients with an abscess (abdominal or pelvic) present during the initial surgery
- Patients with a history of pulmonary embolus or deep vein thrombosis (DVT) within 1 year of surgery
Key Trial Info
Start Date :
June 1 1998
Trial Type :
INTERVENTIONAL
End Date :
August 1 2003
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00130715
Start Date
June 1 1998
End Date
August 1 2003
Last Update
March 12 2015
Active Locations (21)
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1
Mayo Clinic
Scottsdale, Arizona, United States
2
Kaiser Permanente Medical Center
Los Angeles, California, United States
3
USC School of Medicine
Los Angeles, California, United States
4
Harbor UCLA
Torrence, California, United States