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

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

U.S. FDA Resources

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

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:
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 May 21, 2013