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Ligation of the Intersphincteric Fistula Tract (LIFT) + Biodesign for Anal Fistula (LIFT+Graft)

This study has been completed.
Information provided by (Responsible Party):
Cook Identifier:
First received: May 16, 2012
Last updated: February 10, 2015
Last verified: February 2015
The LIFT+Biodesign® study is a post-market observational study to evaluate the rate of fistula closure in patients with persistent trans-sphincteric anal fistula who receive the Biodesign® Tissue graft as part of their LIFT procedure.

Condition Intervention
Anal Fistula
Device: reinforce soft tissue

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ligation of the Intersphincteric Fistula Tract With Tissue Graft Placement for Treatment of Persistent Trans-sphincteric Anal Fistula

Resource links provided by NLM:

Further study details as provided by Cook:

Primary Outcome Measures:
  • Closure of the anal fistula [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Closure of the anal fistula [ Time Frame: 12 months ]

Enrollment: 28
Study Start Date: January 2013
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
LIFT+Biodesign Device: reinforce soft tissue
reinforce soft tissue


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Regional and Community Hospitals

Inclusion Criteria:

  • Persistent primary or recurrent trans-sphincteric anal fistula

Exclusion Criteria:

  • Patients with prior fistulotomy, fistulectomy, LIFT, cutting seton or advancement flap procedure
  • Fistula with multiple tracts
  • Recto-vaginal fistula
  • Active infection in the anal fistula
  • Physical allergies or cultural objections to porcine products
  • Patient is not medically fit to undergo the LIFT procedure as judged by the treating physician
  • Previous diagnosis of collagen disorder
  • History of Crohn's Disease, Irritable Bowel Syndrome, radiation therapy in the rectoanal region
  Contacts and Locations
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Please refer to this study by its identifier: NCT01602081

United States, California
University of California Irvine
Orange, California, United States, 92868
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Indiana
Indiana University Hospitals
Indianapolis, Indiana, United States, 46202
Kendrick Regional Center
Indianapolis, Indiana, United States, 46237
United States, Louisiana
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
United States, New York
Mount Sinai Hospital
New York, New York, United States, 10021
United States, Ohio
Case Medical Center
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19106
Sponsors and Collaborators
  More Information

Responsible Party: Cook Identifier: NCT01602081     History of Changes
Other Study ID Numbers: 10-012
Study First Received: May 16, 2012
Last Updated: February 10, 2015

Keywords provided by Cook:
Anal fistula
Ligation of the intersphincteric fistula tract
Tissue graft

Additional relevant MeSH terms:
Rectal Fistula
Pathological Conditions, Anatomical
Intestinal Fistula
Digestive System Fistula
Digestive System Diseases
Intestinal Diseases
Gastrointestinal Diseases
Rectal Diseases processed this record on April 24, 2017