Seprafilm in the Reduction of Incidence of Bowel Obstruction in General Surgery

Completed · Not applicable

Conditions studied: Intestinal Obstruction, Digestive System Surgical Procedures

In brief

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.

Key facts

Study ID

NCT00130715

Run by

Genzyme, a Sanofi Company

Starts

1998-06-01

Expected to finish

2003-08-01

Last updated by the study team

2015-03-12

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients who were undergoing colon and/or rectal resections and/or adhesiolysis for treatment of bowel obstruction

You may not qualify if…

• 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

Where it is running

• Mayo Clinic — Scottsdale, Arizona, United States
• Kaiser Permanente Medical Center — Los Angeles, California, United States
• USC School of Medicine — Los Angeles, California, United States
• Harbor UCLA — Torrence, California, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• Cleveland Clinic — Weston, Florida, United States
• Johns Hopkins Medical Center — Baltimore, Maryland, United States
• Boston Medical Center — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Mayo Medical Center — Rochester, Minnesota, United States
• Colon & Rectal Surgery Associates — Saint Paul, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Mount Sinai School of Medicine — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• University of Texas Medical School — Houston, Texas, United States
• Mount Sinai Hospital — Toronto, Ontario, Canada
• University of Erlangen — Erlangen, Germany
• University Hospital Nijmegen — Nijmegan, Netherlands
• University of Hull — Hull, United Kingdom
• St. Mary's Hospital — London, United Kingdom

Full record on ClinicalTrials.gov

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