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
1 other identifier
interventional
N/A
5 countries
21
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jun 1998
Longer than P75 for not_applicable
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 1998
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2003
CompletedFirst Submitted
Initial submission to the registry
August 15, 2005
CompletedFirst Posted
Study publicly available on registry
August 16, 2005
CompletedMarch 12, 2015
March 1, 2015
August 15, 2005
March 11, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reducing the incidence of bowel obstruction following intestinal resection, and subsequently, reducing the number of re-operations
Interventions
Eligibility Criteria
You may qualify if:
- Patients who were undergoing colon and/or rectal resections and/or adhesiolysis for treatment of bowel obstruction
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Mayo Clinic
Scottsdale, Arizona, United States
Kaiser Permanente Medical Center
Los Angeles, California, United States
USC School of Medicine
Los Angeles, California, United States
Harbor UCLA
Torrence, California, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Cleveland Clinic
Weston, Florida, United States
Johns Hopkins Medical Center
Baltimore, Maryland, United States
Boston Medical Center
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Mayo Medical Center
Rochester, Minnesota, United States
Colon & Rectal Surgery Associates
Saint Paul, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Mount Sinai School of Medicine
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
University of Texas Medical School
Houston, Texas, United States
Mount Sinai Hospital
Toronto, Ontario, Canada
University of Erlangen
Erlangen, Germany
University Hospital Nijmegen
Nijmegan, Netherlands
University of Hull
Hull, United Kingdom
St. Mary's Hospital
London, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 15, 2005
First Posted
August 16, 2005
Study Start
June 1, 1998
Study Completion
August 1, 2003
Last Updated
March 12, 2015
Record last verified: 2015-03