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

This study has been completed.
Information provided by:
Sanofi Identifier:
First received: August 15, 2005
Last updated: March 11, 2015
Last verified: March 2015
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.

Condition Intervention
Intestinal Obstruction
Digestive System Surgical Procedures
Device: Seprafilm Bioresorbable Membrane

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Multicenter, Controlled Evaluation of the Efficacy and Safety of Seprafilm in the Reduction of Incidence of Bowel Obstruction in General Surgery

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Reducing the incidence of bowel obstruction following intestinal resection, and subsequently, reducing the number of re-operations

Study Start Date: June 1998
Estimated Study Completion Date: August 2003

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00130715

  Show 21 Study Locations
Sponsors and Collaborators
Genzyme, a Sanofi Company
  More Information Identifier: NCT00130715     History of Changes
Other Study ID Numbers: SF97-0601 
Study First Received: August 15, 2005
Last Updated: March 11, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Patients undergoing a variety of abdominal surgical procedures

Additional relevant MeSH terms:
Intestinal Obstruction
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases processed this record on April 27, 2016