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

August 15, 2005
October 19, 2006
June 1998
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Reducing the incidence of bowel obstruction following intestinal resection, and subsequently, reducing the number of re-operations
Reducing the incidence of bowel obstruction following intestinal resection, and subsequently, reducing the number of re-operations.
Complete list of historical versions of study NCT00130715 on ClinicalTrials.gov Archive Site
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Seprafilm in the Reduction of Incidence of Bowel Obstruction in General Surgery
A Prospective, Randomized, Multicenter, Controlled Evaluation of the Efficacy and Safety of Seprafilm in the Reduction of Incidence of Bowel Obstruction in General Surgery

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.

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Interventional
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Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
  • Intestinal Obstruction
  • Digestive System Surgical Procedures
Device: Seprafilm Bioresorbable Membrane
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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August 2003
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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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Germany,   Netherlands,   United Kingdom
 
NCT00130715
SF97-0601
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Genzyme, a Sanofi Company
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Not Provided
Genzyme, a Sanofi Company
October 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP