Anal FistulaLIFT vs PLUGNCT00830661
Ligation of Intersphincteric Fistula Tract (LIFT) Procedure Versus Use of an Anal Fistula Plug for Anal Fistula Repair
A study testing Ligation of intersphincteric fistula track procedure and anal fistula plug in people with Anal Fistula, run by Colon and Rectal Surgery Associates, Ltd. at 4 sites in 2 countries.
Trial summary
Anal fistulae are a difficult problem to treat. The optimal treatment for fistula involving the anal sphincter is unclear. Two standardly used methods of treatment are the ligation of intersphincteric fistula track (LIFT) procedure and the use of an anal fistula plug. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anal Fistula
- What is being tested?
- Ligation of intersphincteric fistula track procedure and anal fistula plug
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Mar 2009to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects 18 years of age or older.
- Able to understand and provide informed consent or have a legally authorized representative capable of providing consent.
- 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).
Who cannot join
- History or suspicion of Inflammatory Bowel Disease (Crohn's or Ulcerative colitis).
- History of connective tissue disease.
- Rectovaginal fistula.
- Presence of horseshoe fistula.
- History of immunosuppression therapy/treatment within previous six months.
- Presents of a proximal diversion and refractory fistula.
- Any physical conditions, disease, or disorder that would exclude subject from being a candidate for elective surgery.
- Known history of allergy to pork or pork products.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites, 3 recruiting
- Not yet recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Liliana Bordeianou, MD, 617-643-0541
Liliana Bordeianou, MD
- Recruiting
Colon and Rectal Surgery Associates, Ltd
Minneapolis, Minnesota, 55455
Deb Jones, BS, 651-225-7830, djones@crsal.org
Rachael Peterson, BS, 651-225-7817, rpeterson@crsal.org
- Recruiting
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104
Joshua Bleier, MD, Joshua.Bleier@uphs.upenn.edu
Joshua Bleier, MD
Canada1 site, 1 recruiting
- Not yet recruiting
University of Ottawa
Ottawa, Ontario, K1N6N5
Husein Moloo, MD, hmoloo@ottawahospital.on.ca
Jonathon Cook, PhD, jcook@ohri.ca
About this study
Official title: A Randomized, Prospective, Multi-Centered Study Comparing Clinical Outcomes of the Ligation of Intersphincteric Fistula Tract (LIFT)Procedure Versus Use of Anal Fistula Plug (AFP)in the Surgical Repair of Trans-Sphincteric Anal Fistulae of Cryptoglandular Origin
Anal fistulae are a difficult problem to treat. The optimal treatment for fistula involving the anal sphincter is unclear. Two standardly used methods of treatment are the ligation of intersphincteric fistula track (LIFT) procedure and the use of an anal fistula plug. The purpose of this study is to exam the rate of fistula closure between the LIFT procedure and the use of a fistula plug
- Conditions
- Anal Fistula
- Being tested
- Ligation of intersphincteric fistula track procedure, anal fistula plug
- Keywords
- transsphincteric anal fistula, cryptoglandular origin, anal fistula repair, Ligation of Intersphincteric Fistula Track (LIFT) procedure, anal fistula plug (Plug), surgical repair
- Medical subject headings
- Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ligation of intersphincteric fistula track procedureProcedure or surgery
Subjects randomized to this arm will receive the ligation of the intersphincteric fistula track (LIFT) procedure. This procedure will be performed as per standard operating procedure.
anal fistula plugProcedure or surgery
placement of the porcine anal fistula plug as per the instructions for use in product packaging
| Study group | Role | What they receive |
|---|---|---|
| LIFT | Active comparator | those subjects receiving the Ligation of Intersphincteric Fistula Track procedure Receives: Procedure: Ligation of intersphincteric fistula track procedure |
| Plug | Active comparator | those subjects randomized to the receive the placement of the porcine anal fistula plug Receives: Procedure: anal fistula plug |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome 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
Measured: 1month, 3 month, 6 month, 12 month postoperatively
Secondary outcomes (1)
Secondary measures will include level of fecal incontinence, fecal incontinence quality of life, complication rates, and rate of closure after re-operation
Measured: 1 month, 3 month, 6 month, 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2009 (estimated)
- Study startMar 2009
- Primary completionMar 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal FistulaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Colon and Rectal Surgery Associates, Ltd.
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania, University of Ottawa, Massachusetts General Hospital
- Investigators
- Heather L Rossi, MD, Principal investigator, University of Minnesota/Colon and Rectal Surgery Associates, Ltd.Husein Moloo, MD, Principal investigator, University of OttawaJoshua Bleier, MD, Principal investigator, University of Pennsylvania Health SystemLiliana Bordeianou, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00830661
- Sponsor's protocol ID
- SMG1108
- Acronym
- LIFT vs PLUG
- Status last verified
- May 2009
- First submitted
- 27 Jan 2009
- Last updated
- 29 May 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Prospective, Multi-Centered Study Comparing Clinical Outcomes of the Ligation of Intersphincteric Fistula Tract (LIFT)Procedure Versus Use of Anal Fistula Plug (AFP)in the Surgical Repair of Trans-Sphincteric Anal Fistulae of Cryptoglandular Origin
- ClinicalTrials.gov ID
- NCT00830661
- Acronym / sponsor ID
- LIFT vs PLUG / SMG1108
- Conditions
- Anal Fistula
- Keywords
- transsphincteric anal fistula, cryptoglandular origin, anal fistula repair, Ligation of Intersphincteric Fistula Track (LIFT) procedure, anal fistula plug (Plug), surgical repair
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Colon and Rectal Surgery Associates, Ltd.University, hospital or other
- Collaborators
- University of Pennsylvania, University of Ottawa, Massachusetts General Hospital
- Study start
- Mar 2009
- Primary completion
- Mar 2012 (estimated)
- First posted
- 28 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Anal fistulae are a difficult problem to treat. The optimal treatment for fistula involving the anal sphincter is unclear. Two standardly used methods of treatment are the ligation of intersphincteric fistula track (LIFT) procedure and the use of an anal fistula plug. The purpose of this study is to exam the rate of fistula closure between the LIFT procedure and the use of a fistula plug
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LIFT | Active comparator | Procedure: Ligation of intersphincteric fistula track procedurethose subjects receiving the Ligation of Intersphincteric Fistula Track procedure |
| Plug | Active comparator | Procedure: anal fistula plugthose subjects randomized to the receive the placement of the porcine anal fistula plug |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female subjects 18 years of age or older.
- Able to understand and provide informed consent or have a legally authorized representative capable of providing consent.
- 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).
Key exclusion criteria (8 listed)
- History or suspicion of Inflammatory Bowel Disease (Crohn's or Ulcerative colitis).
- History of connective tissue disease.
- Rectovaginal fistula.
- Presence of horseshoe fistula.
- History of immunosuppression therapy/treatment within previous six months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ligation of intersphincteric fistula track procedureSubjects randomized to this arm will receive the ligation of the intersphincteric fistula track (LIFT) procedure. This procedure will be performed as per standard operating procedure. | Procedure or surgery | LIFT |
| anal fistula plugplacement of the porcine anal fistula plug as per the instructions for use in product packaging | Procedure or surgery | Plug |
Primary outcome
The primary outcome 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
Time frame: 1month, 3 month, 6 month, 12 month postoperatively
1 secondary outcome
Secondary measures will include level of fecal incontinence, fecal incontinence quality of life, complication rates, and rate of closure after re-operation
Time frame: 1 month, 3 month, 6 month, 12 months postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather L Rossi, MD principal investigator
University of Minnesota/Colon and Rectal Surgery Associates, Ltd.
Husein Moloo, MD principal investigator
University of Ottawa
Joshua Bleier, MD principal investigator
University of Pennsylvania Health System
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ligation of intersphincteric fistula track procedure and anal fistula plug in people with Anal Fistula, run by Colon and Rectal Surgery Associates, Ltd. at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Deb J Jones, BS (651-225-7830, djones@crsal.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome 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 (time frame: 1month, 3 month, 6 month, 12 month postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2009.