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

Intestinal Obstruction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00130715
• Other study ID #: SF97-0601
• Status: Completed
• Phase: N/A
• First received: August 15, 2005
• Last updated: March 11, 2015
• Start date: June 1998
• Est. completion date: August 2003

Study information

• Verified date: March 2015
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: August 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Digestive System Surgical Procedures
• Intestinal Obstruction

Intervention

Device:
• Seprafilm Bioresorbable Membrane

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario
Germany	University of Erlangen	Erlangen
Netherlands	University Hospital Nijmegen	Nijmegan
United Kingdom	University of Hull	Hull
United Kingdom	St. Mary's Hospital	London
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	Cleveland Clinic	Cleveland	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	University of Texas Medical School	Houston	Texas
United States	Kaiser Permanente Medical Center	Los Angeles	California
United States	USC School of Medicine	Los Angeles	California
United States	Mount Sinai School of Medicine	New York	New York
United States	Mayo Medical Center	Rochester	Minnesota
United States	Mayo Clinic	Scottsdale	Arizona
United States	Washington University School of Medicine	St. Louis	Missouri
United States	Colon & Rectal Surgery Associates	St. Paul	Minnesota
United States	Harbor UCLA	Torrence	California
United States	Washington Hospital Center	Washington	District of Columbia
United States	Cleveland Clinic	Weston	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Genzyme, a Sanofi Company

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reducing the incidence of bowel obstruction following intestinal resection, and subsequently, reducing the number of re-operations