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

A Prospective, Randomized, Multicenter, Controlled Evaluation of the Efficacy and Safety of Seprafilm in the Reduction of Incidence of Bowel Obstruction in General Surgery

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.

Inclusion Criteria:

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

Exclusion Criteria:

• 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