Seprafilm in the Reduction of Incidence of Bowel Obstruction in General Surgery
- Conditions
- Intestinal ObstructionDigestive System Surgical Procedures
- Registration Number
- NCT00130715
- Lead Sponsor
- Genzyme, a Sanofi Company
- 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 use of Seprafilm occurring within 30 days postoperatively, and the incidence of abdominopelvic abscess within 6 months postoperatively.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
- Patients who were undergoing colon and/or rectal resections and/or adhesiolysis for treatment of bowel obstruction
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Reducing the incidence of bowel obstruction following intestinal resection, and subsequently, reducing the number of re-operations
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (20)
Mayo Clinic
🇺🇸Scottsdale, Arizona, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
Kaiser Permanente Medical Center
🇺🇸Los Angeles, California, United States
USC School of Medicine
🇺🇸Los Angeles, California, United States
Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Harbor UCLA
🇺🇸Torrence, California, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Johns Hopkins Medical Center
🇺🇸Baltimore, Maryland, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Mayo Medical Center
🇺🇸Rochester, Minnesota, United States
Washington University School of Medicine
🇺🇸St. Louis, Missouri, United States
Colon & Rectal Surgery Associates
🇺🇸St. Paul, Minnesota, United States
Mount Sinai School of Medicine
🇺🇸New York, New York, United States
Mount Sinai Hospital
🇨🇦Toronto, Ontario, Canada
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
University of Texas Medical School
🇺🇸Houston, Texas, United States
St. Mary's Hospital
🇬🇧London, United Kingdom
University of Erlangen
🇩🇪Erlangen, Germany
University Hospital Nijmegen
🇳🇱Nijmegan, Netherlands
University of Hull
🇬🇧Hull, United Kingdom