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LIFT Procedure vs. Anal Fistula Plug for Anal Fistulas (LIFT vs PLUG Trial)
Philadelphia, PA
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
No Placebo-Only Group
Summary
This trial is comparing two common treatments for anal fistulae to see which is more effective.
See full description
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.Check my eligibility
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.See study design
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 belowSelect...
I have a confirmed diagnosis of a trans-sphincteric fistula of cryptoglandular origin.
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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.
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Select...
I have a connection between my rectum and vagina.
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Select...
I have a horseshoe fistula.
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Select...
I have a non-healing wound near a surgical diversion.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Closest Location:University of Pennsylvania Health System· Philadelphia, PA· 414 miles
Who is running the clinical trial?
University of PennsylvaniaOTHER
2,103 Previous Clinical Trials
45,308,594 Total Patients Enrolled
Colon and Rectal Surgery Associates, Ltd.Lead Sponsor
2 Previous Clinical Trials
371 Total Patients Enrolled
University of OttawaOTHER
226 Previous Clinical Trials
266,936 Total Patients Enrolled
Massachusetts General HospitalOTHER
3,048 Previous Clinical Trials
13,417,566 Total Patients Enrolled
Heather L Rossi, MDPrincipal InvestigatorUniversity of Minnesota/Colon and Rectal Surgery Associates, Ltd.
Husein Moloo, MDPrincipal InvestigatorUniversity of Ottawa
Joshua Bleier, MDPrincipal InvestigatorUniversity of Pennsylvania Health System
Liliana Bordeianou, MDPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
5 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can understand and agree to the study's terms, or I have someone who can legally do this for me.I have no health issues that would prevent me from having surgery.I have a confirmed diagnosis of a trans-sphincteric fistula of cryptoglandular origin.I have a horseshoe fistula.I have not had immunosuppression therapy in the last 6 months.I have a non-healing wound near a surgical diversion.I have or might have Crohn's disease or ulcerative colitis.I have a connection between my rectum and vagina.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: LIFT
- Group 2: Plug
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.