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

Primary Purpose

Intestinal Obstruction, Digestive System Surgical Procedures

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Seprafilm Bioresorbable Membrane
Sponsored by
Genzyme, a Sanofi Company
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intestinal Obstruction focused on measuring Patients undergoing a variety of abdominal surgical procedures

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic
  • Kaiser Permanente Medical Center
  • USC School of Medicine
  • Harbor UCLA
  • Washington Hospital Center
  • Cleveland Clinic
  • Johns Hopkins Medical Center
  • Boston Medical Center
  • Brigham and Women's Hospital
  • Mayo Medical Center
  • Colon & Rectal Surgery Associates
  • Washington University School of Medicine
  • Mount Sinai School of Medicine
  • Duke University Medical Center
  • Cleveland Clinic
  • University of Texas Medical School
  • Mount Sinai Hospital
  • University of Erlangen
  • University Hospital Nijmegen
  • University of Hull
  • St. Mary's Hospital

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 15, 2005
Last Updated
March 11, 2015
Sponsor
Genzyme, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT00130715
Brief Title
Seprafilm in the Reduction of Incidence of Bowel Obstruction in General Surgery
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 Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
June 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Genzyme, a Sanofi Company

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intestinal Obstruction, Digestive System Surgical Procedures
Keywords
Patients undergoing a variety of abdominal surgical procedures

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Seprafilm Bioresorbable Membrane
Primary Outcome Measure Information:
Title
Reducing the incidence of bowel obstruction following intestinal resection, and subsequently, reducing the number of re-operations

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Mayo Clinic
City
Scottsdale
State/Province
Arizona
Country
United States
Facility Name
Kaiser Permanente Medical Center
City
Los Angeles
State/Province
California
Country
United States
Facility Name
USC School of Medicine
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Harbor UCLA
City
Torrence
State/Province
California
Country
United States
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
Cleveland Clinic
City
Weston
State/Province
Florida
Country
United States
Facility Name
Johns Hopkins Medical Center
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Mayo Medical Center
City
Rochester
State/Province
Minnesota
Country
United States
Facility Name
Colon & Rectal Surgery Associates
City
St. Paul
State/Province
Minnesota
Country
United States
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
University of Texas Medical School
City
Houston
State/Province
Texas
Country
United States
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
University of Erlangen
City
Erlangen
Country
Germany
Facility Name
University Hospital Nijmegen
City
Nijmegan
Country
Netherlands
Facility Name
University of Hull
City
Hull
Country
United Kingdom
Facility Name
St. Mary's Hospital
City
London
Country
United Kingdom

12. IPD Sharing Statement

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

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