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LIFT Procedure vs. Anal Fistula Plug for Anal Fistulas (LIFT vs PLUG Trial)
N/A
Waitlist Available
Led By Husein Moloo, 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1month, 3 month, 6 month, 12 month postoperatively
Awards & highlights
LIFT vs PLUG Trial 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.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.
LIFT vs PLUG Trial 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.
LIFT vs PLUG Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1month, 3 month, 6 month, 12 month postoperatively
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1month, 3 month, 6 month, 12 month postoperatively
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The measure of this study will be to compare the rate of fistula closure between the ligation of the intersphincteric fistula track (LIFT) procedure and the use of a porcine bioabsorbable anal fistula plug
Secondary outcome measures
Secondary measures will include level of fecal incontinence, fecal incontinence quality of life, complication rates, and rate of closure after re-operation
LIFT vs PLUG 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
2,000 Previous Clinical Trials
42,879,964 Total Patients Enrolled
Colon and Rectal Surgery Associates, Ltd.Lead Sponsor
2 Previous Clinical Trials
371 Total Patients Enrolled
University of OttawaOTHER
205 Previous Clinical Trials
265,967 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there opportunities for new enrollees in this clinical trial?
"As indicated on clinicaltrials.gov, this particular trial is no longer welcoming applicants despite being initially posted on March 1st 2009 and recently updated the 28th of May in the same year. Nonetheless, there are 110 other trials actively recruiting participants at present."
Answered by AI
At how many sites can this clinical experiment be conducted?
"This trial is presently being facilitated at 4 distinct sites. Patients in Philadelphia, Minneapolis and Ottawa have convenient access to the research, along with those located near 4 other cities. It would be most prudent for participants to select a site closest to them so as not to overextend themselves during travel."
Answered by AI
Who else is applying?
What state do they live in?
New Jersey
What site did they apply to?
University of Pennsylvania Health System
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
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