Anorectal FistulaPhase 3LIFT-plugNCT01478139
Ligation of Intersphincteric Fistula Tract (LIFT) Versus LIFT-plug Procedure for Anal Fistula Repair
A Phase 3 study testing LIFT-plug and LIFT in people with Anorectal Fistula and Extracellular Matrix Alteration, run by Zhen Jun Wang at 5 sites in China.
Trial summary
The purpose of this study is to validate the effect of Ligation of Intersphincteric Fistula Tract (LIFT) Versus LIFT-plug procedure for Anal Fistula Repair. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anorectal Fistula, Extracellular Matrix Alteration
- What is being tested?
- LIFT-plug and LIFT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 5 sitesChina
- Study dates
- Feb 2011to Nov 2013
- Phase
- Phase 3
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects over eighteen years old or less than 65 years old.
- Able to understand and provide informed consent or have a legally authorized representative capable of providing consent.
- Clinical diagnosis of primary anal fistula categorized as trans-sphincteric fistula tract determined to be of cryptoglandular origin (primary or recurrent).
Who cannot join
- Presence of horseshoe fistula.
- History of immunosuppression therapy/treatment within previous six months.
- Fistulas with active abscess, infection, or acute inflammation
- History of Choron's Disease
- History of Ulcerative Colitis
- History of HIV or other immune system disease
Show all 10Show fewer
- History of collagen disease
- History of radiation to the anorectal region
- Allergies to pig tissue or pig products
- Religious or cultural objection to the use of pig tissue
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100000
Chao Wen Chen, M.D., 86-013901038133, ccw0070890@sina.com
Chao Wen Chen, M.D.
- Recruiting
Beijing Chaoyang Hospital, Capital Medical University
Beijing, Beijing Municipality, 100020
Zhen Jun Wang, M.D., 86-013601393711, wang3zj@sohu.com
Zhen Jun Wang
- Recruiting
Tianjin Third Central Hospital
Tianjin, Tianjin Municipality, 300000
Wei Liang Song, M.D., 86-015522242541, songwl2008@sina.com
Wei Liang Song, M.D.
- Recruiting
Shaanxi Provincial People's Hospital
Xi’an, Shanxi, 710000
Xiao Qiang Wang, M.D., 86-013991966126, Xiaoqiangwang2008@yahoo.cn
Xiao Qiang Wang, M.D.
- Recruiting
Xi'an Jiaotong University College of Medicine
Xi’an, Shanxi, 710000
Xiang Ming Che, M.D., 86-018991232115, chexiang@mail.xjtu.edu.cn
Xiang Ming Che, M.D.
About this study
Official title: Ligation of Intersphincteric Fistula Tract (LIFT) Versus LIFT-plug Procedure for Anal Fistula Repair: a Multicenter, Randomized, Open-label, Parallel Controlled Trial
The purpose of this study is to validate the effect of Ligation of Intersphincteric Fistula Tract (LIFT) Versus LIFT-plug procedure for Anal Fistula Repair.
Read the detailed description
The management of trans-sphincteric anal fistulae of cryptoglandular origin is challenging. The ideal management is to effectively heal the fistula without compromising continence, avoid fistula recurrence, and quick recovery. Ligation of the intersphincteric fistula tract (LIFT) and LIFT reinforced with a bioprosthetic graft (BioLIFT) are two recently reported procedures that showed improved healing results. In the LIFT, Rojanasakul et al proposed to identify the fistula tract in the intersphincteric space and subsequent division and ligation of the tract, and the primary healing rate was 94.4%. The following studies reported slightly lower results, but the recurrence rate was as high as 18% to 28%. Ellis et al subsequently described a modified LIFT procedure (BioLIFT procedure) in which a bioprosthetic was placed in the intersphincteric plane to reinforce the closure of the fistula tract (BioLIFT procedure), and yielded a healing rate of 94% in 31 patients who had a minimum of 1 year of follow-up after their last treatment.
The investigators modified the LIFT procedure by combining LIFT with the technique of anal fistula plug. The bioprosthetic plug was placed into the fistula tract through the opening in the external sphincter to the external opening in the skin after LIFT procedure. The present study was designed to assess the preliminary results of LIFT-Plug technique prospectively.
The purpose of this study is to validate the effect of Ligation of Intersphincteric Fistula Tract (LIFT) Versus LIFT-plug procedure for Anal Fistula Repair.
- Conditions
- Anorectal Fistula, Extracellular Matrix Alteration
- Being tested
- LIFT-plug, LIFT
- Keywords
- anorectal fistula, acellular dermal matrix, ligation of intersphincteric fistula tract, ligation of intersphincteric fistula tract and plug, complications of treatment, recurrence
- Medical subject headings
- Rectal Fistula, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIFT-plugProcedure or surgery
Subjects randomized to this arm will receive the ligation of the intersphincteric fistula track and plug (LIFT-plug) procedure
LIFTProcedure or surgery
Subjects randomized to this arm will receive the ligation of the intersphincteric fistula track (LIFT) procedure
| Study group | Role | What they receive |
|---|---|---|
| LIFT | Experimental | Subjects randomized to this arm will receive the ligation of the intersphincteric fistula track (LIFT) procedure Receives: Procedure: LIFT |
| LIFT-plug | Experimental | Subjects randomized to this arm will receive the ligation of the intersphincteric fistula track and plug (LIFT-plug) procedure Receives: Procedure: LIFT-plug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing time
Measured: 1month, 3 month, 6 month postoperatively
Secondary outcomes (4)
recurrence rate
Measured: 1month, 3 month, 6 month postoperatively
postoperative pain
The methodology used for the evaluation of postoperative perineal pain severity and relief, is the visual analogue scale (VAS) (1-10). We considered positive a VAS > 4.
Measured: 1month, 3 month, 6 month postoperatively
fecal incontinence
Measured: 1month, 3 month, 6 month postoperatively
complication rates
Measured: 1month, 3 month, 6 month postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2011 (estimated)
- Study startFeb 2011
- Primary completionNov 2013 (estimated)
- Study completionNov 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorectal 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhen Jun Wang
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Third Hospital, Tianjin Third Central Hospital, Xi'an Jiaotong University, Shaanxi Provincial People's Hospital
- Responsible party
- Sponsor-investigator, Zhen Jun Wang, Beijing Chao Yang Hospital
- Investigators
- Zhen Jun Wang, M.D., Study chair, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01478139
- Sponsor's protocol ID
- LIFTplug-110212
- Acronym
- LIFT-plug
- Status last verified
- Nov 2013
- First submitted
- 10 Nov 2011
- Last updated
- 28 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ligation of Intersphincteric Fistula Tract (LIFT) Versus LIFT-plug Procedure for Anal Fistula Repair: a Multicenter, Randomized, Open-label, Parallel Controlled Trial
- ClinicalTrials.gov ID
- NCT01478139
- Acronym / sponsor ID
- LIFT-plug / LIFTplug-110212
- Conditions
- Anorectal Fistula, Extracellular Matrix Alteration
- Keywords
- anorectal fistula, acellular dermal matrix, ligation of intersphincteric fistula tract, ligation of intersphincteric fistula tract and plug, complications of treatment, recurrence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Zhen Jun WangUniversity, hospital or other
- Collaborators
- Peking University Third Hospital, Tianjin Third Central Hospital, Xi'an Jiaotong University, Shaanxi Provincial People's Hospital
- Study start
- Feb 2011
- Primary completion
- Nov 2013 (estimated)
- Study completion
- Nov 2013 (estimated)
- First posted
- 23 Nov 2011 (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.
The purpose of this study is to validate the effect of Ligation of Intersphincteric Fistula Tract (LIFT) Versus LIFT-plug procedure for Anal Fistula Repair.
Detailed description
The management of trans-sphincteric anal fistulae of cryptoglandular origin is challenging. The ideal management is to effectively heal the fistula without compromising continence, avoid fistula recurrence, and quick recovery. Ligation of the intersphincteric fistula tract (LIFT) and LIFT reinforced with a bioprosthetic graft (BioLIFT) are two recently reported procedures that showed improved healing results. In the LIFT, Rojanasakul et al proposed to identify the fistula tract in the intersphincteric space and subsequent division and ligation of the tract, and the primary healing rate was 94.4%. The following studies reported slightly lower results, but the recurrence rate was as high as 18% to 28%. Ellis et al subsequently described a modified LIFT procedure (BioLIFT procedure) in which a bioprosthetic was placed in the intersphincteric plane to reinforce the closure of the fistula tract (BioLIFT procedure), and yielded a healing rate of 94% in 31 patients who had a minimum of 1 year of follow-up after their last treatment.
The investigators modified the LIFT procedure by combining LIFT with the technique of anal fistula plug. The bioprosthetic plug was placed into the fistula tract through the opening in the external sphincter to the external opening in the skin after LIFT procedure. The present study was designed to assess the preliminary results of LIFT-Plug technique prospectively.
The purpose of this study is to validate the effect of Ligation of Intersphincteric Fistula Tract (LIFT) Versus LIFT-plug procedure for Anal Fistula Repair.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LIFT | Experimental | Procedure: LIFTSubjects randomized to this arm will receive the ligation of the intersphincteric fistula track (LIFT) procedure |
| LIFT-plug | Experimental | Procedure: LIFT-plugSubjects randomized to this arm will receive the ligation of the intersphincteric fistula track and plug (LIFT-plug) procedure |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female subjects over eighteen years old or less than 65 years old.
- Able to understand and provide informed consent or have a legally authorized representative capable of providing consent.
- Clinical diagnosis of primary anal fistula categorized as trans-sphincteric fistula tract determined to be of cryptoglandular origin (primary or recurrent).
Key exclusion criteria (10 listed)
- Presence of horseshoe fistula.
- History of immunosuppression therapy/treatment within previous six months.
- Fistulas with active abscess, infection, or acute inflammation
- History of Choron's Disease
- History of Ulcerative Colitis
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 |
|---|---|---|
| LIFT-plugSubjects randomized to this arm will receive the ligation of the intersphincteric fistula track and plug (LIFT-plug) procedure | Procedure or surgery | LIFT-plug |
| LIFTSubjects randomized to this arm will receive the ligation of the intersphincteric fistula track (LIFT) procedure | Procedure or surgery | LIFT |
Primary outcome
Healing time
Time frame: 1month, 3 month, 6 month postoperatively
4 secondary outcomes
recurrence rate
Time frame: 1month, 3 month, 6 month postoperatively
postoperative pain
Time frame: 1month, 3 month, 6 month postoperatively
fecal incontinence
Time frame: 1month, 3 month, 6 month postoperatively
complication rates
Time frame: 1month, 3 month, 6 month postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2013.
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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.
Zhen Jun Wang, M.D. study chair
Beijing Chao Yang Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LIFT-plug and LIFT in people with Anorectal Fistula and Extracellular Matrix Alteration, run by Zhen Jun Wang at 5 sites in China.
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 10 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 28 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Zhen Jun Wang, M.D. (86-1085231604, wang3zj@sohu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing time (time frame: 1month, 3 month, 6 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 28 Nov 2013; AzTrials last refreshed its copy on 8 Nov 2026.