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Baltimore, Maryland

  • Digestive System Surgical Procedures

Purpose:

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.


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


Study is Available At:


Original ID:

SF97-0601


NCT ID:

NCT00130715


Secondary ID:


Study Acronym:


Brief Title:

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


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

85 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Sanofi


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: S


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:


Study Dates

Start Date:June 1998
Completion Date:August 2003
Verification Date:March 2015
Last Changed Date:March 11, 2015
First Received Date:August 15, 2005

Study Outcomes

Outcome Type:Primary Outcome
Measure:Reducing the incidence of bowel obstruction following intestinal resection, and subsequently, reducing the number of re-operations
Safety Issues:False

Study Interventions

Intervention Type:Device
Name:Seprafilm Bioresorbable Membrane

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Genzyme, a Sanofi Company

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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