Digestive System Surgical Procedures, Intestinal Obstruction
Conditions
Keywords
Patients undergoing a variety of abdominal surgical procedures
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.
Interventions
DEVICESeprafilm Bioresorbable Membrane
Sponsors
Genzyme, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reducing the incidence of bowel obstruction following intestinal resection, and subsequently, reducing the number of re-operations | — |
Countries
Canada, Germany, Netherlands, United Kingdom, United States
Outcome results
None listed