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

March 11, 2015 updated by: Genzyme, a Sanofi Company

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada
        • Mount Sinai Hospital
  • Germany
      • Erlangen, Germany
        • University of Erlangen
  • Netherlands
      • Nijmegan, Netherlands
        • University Hospital Nijmegen
  • United Kingdom
      • Hull, United Kingdom
        • University of Hull
      • London, United Kingdom
        • St. Mary's Hospital
  • United States
    • Arizona
      • Scottsdale, Arizona, United States
        • Mayo Clinic
    • California
      • Los Angeles, California, United States
        • Kaiser Permanente Medical Center
      • Los Angeles, California, United States
        • USC School of Medicine
      • Torrence, California, United States
        • Harbor UCLA
    • District of Columbia
      • Washington, District of Columbia, United States
        • Washington Hospital Center
    • Florida
      • Weston, Florida, United States
        • Cleveland Clinic
    • Maryland
      • Baltimore, Maryland, United States
        • Johns Hopkins Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States
        • Boston Medical Center
      • Boston, Massachusetts, United States
        • Brigham and Women's Hospital
    • Minnesota
      • Rochester, Minnesota, United States
        • Mayo Medical Center
      • St. Paul, Minnesota, United States
        • Colon & Rectal Surgery Associates
    • Missouri
      • St. Louis, Missouri, United States
        • Washington University School of Medicine
    • New York
      • New York, New York, United States
        • Mount Sinai School of Medicine
    • North Carolina
      • Durham, North Carolina, United States
        • Duke University Medical Center
    • Ohio
      • Cleveland, Ohio, United States
        • Cleveland Clinic
    • Texas
      • Houston, Texas, United States
        • University of Texas Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Reducing the incidence of bowel obstruction following intestinal resection, and subsequently, reducing the number of re-operations

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genzyme, a Sanofi Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 1998

Study Completion

August 1, 2003

Study Registration Dates

First Submitted

August 15, 2005

First Submitted That Met QC Criteria

August 15, 2005

First Posted (Estimate)

August 16, 2005

Study Record Updates

Last Update Posted (Estimate)

March 12, 2015

Last Update Submitted That Met QC Criteria

March 11, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SF97-0601

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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