Clinical trial NCT00130715: 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
Overall status: COMPLETED
Phase: NA
Conditions: Intestinal Obstruction
Digestive System Surgical Procedures
Keywords: Patients undergoing a variety of abdominal surgical procedures
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-08-16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Reducing the incidence of bowel obstruction following intestinal resection, and subsequently, reducing the number of re-operations
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
city: Los Angeles
country: United States
facility: Kaiser Permanente Medical Center
state: California
city: Los Angeles
country: United States
facility: USC School of Medicine
state: California
city: Torrence
country: United States
facility: Harbor UCLA
state: California
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Weston
country: United States
facility: Cleveland Clinic
state: Florida
city: Baltimore
country: United States
facility: Johns Hopkins Medical Center
state: Maryland
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Medical Center
state: Minnesota
city: St. Paul
country: United States
facility: Colon & Rectal Surgery Associates
state: Minnesota
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Houston
country: United States
facility: University of Texas Medical School
state: Texas
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Erlangen
country: Germany
facility: University of Erlangen
city: Nijmegan
country: Netherlands
facility: University Hospital Nijmegen
city: Hull
country: United Kingdom
facility: University of Hull
city: London
country: United Kingdom
facility: St. Mary's Hospital
Study officials:
References: