ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00130715
Recruitment Status : Completed
First Posted : August 16, 2005
Last Update Posted : March 12, 2015
Sponsor:
Information provided by:
Sanofi

Brief Summary:
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 or disease Intervention/treatment Phase
Intestinal Obstruction Digestive System Surgical Procedures Device: Seprafilm Bioresorbable Membrane Not Applicable

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
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
Study Start Date : June 1998
Study Completion Date : August 2003

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Reducing the incidence of bowel obstruction following intestinal resection, and subsequently, reducing the number of re-operations


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00130715


  Show 21 Study Locations
Sponsors and Collaborators
Genzyme, a Sanofi Company

ClinicalTrials.gov Identifier: NCT00130715     History of Changes
Other Study ID Numbers: SF97-0601
First Posted: August 16, 2005    Key Record Dates
Last Update Posted: March 12, 2015
Last Verified: March 2015

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

Additional relevant MeSH terms:
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents