SF97-0601: Seprafilm in the Reduction of Incidence of Bowel Obstruction in General Surgery

This study has been completed.

Sponsored By:	Genzyme
Information Provided By:	Genzyme
ClinicalTrials.gov Identifier:	NCT00130715

Purpose

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: Treatment, Randomized, Single Blind, Parallel Assignment, Safety/Efficacy Study

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

Further Study Details: 

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

Study start: June 1998; Study completion: August 2003

Eligibility

Ages Eligible for Study: 18 Years - 85 Years, Genders Eligible for Study: Both

Criteria

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

Location Information

Arizona
Mayo Clinic, Scottsdale, Arizona, United States

California
Kaiser Permanente Medical Center, Los Angeles, California, United States
USC School of Medicine, Los Angeles, California, United States
Harbor UCLA, Torrence, California, United States

District of Columbia
Washington Hospital Center, Washington, District of Columbia, United States

Florida
Cleveland Clinic, Weston, Florida, United States

Maryland
Johns Hopkins Medical Center, Baltimore, Maryland, United States

Massachusetts
Boston Medical Center, Boston, Massachusetts, United States
Brigham and Women's Hospital, Boston, Massachusetts, United States

Minnesota
Colon & Rectal Surgery Associates, St. Paul, Minnesota, United States
Mayo Medical Center, Rochester, Minnesota, United States

Missouri
Washington University School of Medicine, St. Louis, Missouri, United States

New York
Mount Sinai School of Medicine, New York, New York, United States

North Carolina
Duke University Medical Center, Durham, North Carolina, United States

Ohio
Cleveland Clinic, Cleveland, Ohio, United States

Texas
University of Texas Medical School, Houston, Texas, United States

Canada, Ontario
Mount Sinai Hospital, Toronto, Ontario, Canada

Germany
University of Erlangen, Erlangen, Germany

Netherlands
University Hospital Nijmegen, Nijmegan, Netherlands

United Kingdom
St. Mary's Hospital, London, United Kingdom
University of Hull, Hull, United Kingdom

More Information

Study ID Numbers: SF97-0601
ClinicalTrials.gov Identifier: NCT00130715
Health Authority: United States: Food and Drug Administration