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

Genzyme, a Sanofi Company

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Conditions

Intestinal Obstruction Digestive System Surgical Procedures

Interventions

Seprafilm Bioresorbable MembraneDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (21)

Mayo Clinic

Scottsdale, Arizona, United States

Kaiser Permanente Medical Center

Los Angeles, California, United States

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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