Seprafilm in the Reduction of Incidence of Bowel Obstruction in General Surgery - Full Text View

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

U.S. FDA Resources

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 as provided by Genzyme:

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

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

Show 21 Study Locations

Sponsors and Collaborators

Genzyme

More Information

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

Keywords provided by Genzyme:

Patients undergoing a variety of abdominal surgical procedures

Study placed in the following topic categories:

Intestinal Obstruction

Digestive System Diseases

Gastrointestinal Diseases

Intestinal Diseases

ClinicalTrials.gov processed this record on October 03, 2008

Sponsored by:	Genzyme
Information provided by:	Genzyme
ClinicalTrials.gov Identifier:	NCT00130715