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LIFT Procedure vs. Anal Fistula Plug for Anal Fistulas (LIFT vs PLUG Trial)

N/A
Waitlist Available
Led By Heather L Rossi, MD
Research Sponsored by Colon and Rectal Surgery Associates, Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has a documented diagnosis, confirmed by physical exam and/or endorectal ultrasound (if available), of a trans-sphincteric fistula tract determined to be of cryptoglandular origin (primary or recurrent)
Be older than 18 years old
Must not have
History or suspicion of Inflammatory Bowel Disease (Crohn's or Ulcerative colitis)
Rectovaginal fistula
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial is comparing two common treatments for anal fistulae to see which is more effective.

Who is the study for?
This trial is for men and women over 18 with a confirmed diagnosis of trans-sphincteric anal fistula of cryptoglandular origin. Candidates must understand the study and consent to participate. Those with inflammatory bowel disease, connective tissue diseases, horseshoe fistulas, recent immunosuppression therapy, certain physical conditions barring surgery, rectovaginal fistulas or pork allergies cannot join.
What is being tested?
The study compares two treatments for anal fistula repair: the LIFT procedure versus an anal fistula plug. It aims to determine which method is more effective at closing the fistula tract.
What are the potential side effects?
While specific side effects are not listed here, typical risks may include pain at the surgical site, infection risk from surgery, potential damage to surrounding tissues or organs during procedures and possible allergic reactions if relevant.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a confirmed diagnosis of a trans-sphincteric fistula of cryptoglandular origin.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have or might have Crohn's disease or ulcerative colitis.
Select...
I have a connection between my rectum and vagina.
Select...
I have a horseshoe fistula.
Select...
I have a non-healing wound near a surgical diversion.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups
Active Control
Group I: LIFTActive Control1 Intervention
those subjects receiving the Ligation of Intersphincteric Fistula Track procedure
Group II: PlugActive Control1 Intervention
those subjects randomized to the receive the placement of the porcine anal fistula plug

Find a Location

Who is running the clinical trial?

University of PennsylvaniaOTHER
2,053 Previous Clinical Trials
43,013,003 Total Patients Enrolled
Colon and Rectal Surgery Associates, Ltd.Lead Sponsor
2 Previous Clinical Trials
371 Total Patients Enrolled
University of OttawaOTHER
213 Previous Clinical Trials
268,148 Total Patients Enrolled

Media Library

Anal fistula plug Clinical Trial Eligibility Overview. Trial Name: NCT00830661 — N/A
Anal Fistulas Research Study Groups: LIFT, Plug
Anal Fistulas Clinical Trial 2023: Anal fistula plug Highlights & Side Effects. Trial Name: NCT00830661 — N/A
Anal fistula plug 2023 Treatment Timeline for Medical Study. Trial Name: NCT00830661 — N/A
~8 spots leftby Sep 2025
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