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

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.

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Key information

Conditions

Intestinal Obstruction Digestive System Diseases Digestive System Surgical Procedures Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai Hospital, Toronto, Ontario, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Seprafilm Bioresorbable Membrane

Device

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Genzyme, a Sanofi Company

Industry

Registry information

Official study 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

Important dates

Study start: 1998
Study completion: 2003
First posted: Aug 16, 2005
Registry last updated: Mar 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed