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

This study has been completed.
Sponsor:
Information provided by:
Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT00130715
First received: August 15, 2005
Last updated: October 19, 2006
Last verified: October 2006
  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: 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 Genzyme, a Sanofi Company:

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
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00130715

  Hide Study Locations
Locations
United States, Arizona
Mayo Clinic
Scottsdale, Arizona, United States
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
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States
United States, Florida
Cleveland Clinic
Weston, Florida, United States
United States, Maryland
Johns Hopkins Medical Center
Baltimore, Maryland, United States
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
United States, Minnesota
Mayo Medical Center
Rochester, Minnesota, United States
Colon & Rectal Surgery Associates
St. Paul, Minnesota, United States
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States
United States, New York
Mount Sinai School of Medicine
New York, New York, United States
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States
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
University of Hull
Hull, United Kingdom
St. Mary's Hospital
London, United Kingdom
Sponsors and Collaborators
Genzyme, a Sanofi Company
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00130715     History of Changes
Other Study ID Numbers: SF97-0601
Study First Received: August 15, 2005
Last Updated: October 19, 2006
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 16, 2014