Anal FistulaLIFT 02NCT04310800
LIFT-plug vs LIFT, a RCT Trial
A study testing LIFT-plug technique in people with Anal Fistula and LIFT-plug, run by Zhen Jun Wang at 7 sites in China.
Trial summary
To validate the effect of Ligation of Intersphincteric Fistula Tract (LIFT) Versus LIFT-plug procedure for Anal Fistula Repair in 7 medical centers Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Anal Fistula, LIFT-plug, Healing Rate
- What is being tested?
- LIFT-plug technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 384 participants
- Where
- 7 sitesChina
- Study dates
- 1 Jan 2018to 31 Dec 2020
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- High transsphincteric fistula (involving > 30% of the external anal sphincter)
- Age between 18 and 70 years
- Chronic anal fistula with fistula tracts no more than 2
- No active sepsis or abscess
Who cannot join
- Fistulas with active inflammation or purulence
- Fistulas related to tumor, Crohn's disease, tuberculosis or acquired immune deficiency syndrome
- Poorly controlled diabetes with fasting blood-glucose > 8mmol/L
- Preexisting incontinence
- Multiple fistula tracts > 2
- Fasting blood-glucose ≥ 8mmol/L
Show all 11Show fewer
- Allergic or contraindication for the use of animal protein
- Pregnant women
- Expected life less than 6 months
- With anorectal abscess
- Serious liver (Child-Pugh C) and chronic kidney disease (CKD) stage 3
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites, 7 recruiting
- Recruiting
Beijing Anorectal Hospital
Beijing, Beijing Municipality, 100000
Yuru Zhang, M.D.
Yuru Zhang, M.D.
- Recruiting
Beijing Luhe Hospital
Beijing, Beijing Municipality, 100000
Guodan Jiang, M.D., caijianhua10020@163.com
Guodan JIANG, M.D.
- Recruiting
Beijing shunyi district hospital
Beijing, Beijing Municipality, 100000
Xuefeng Xue, MD, 8618510665770, Min_liu12201@163.com
- 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
Rocket force general hospital
Beijing, Beijing Municipality, 100000
Ke Zhao, M.D., 86-013370120126
Ke Zhao, M.D.
- Recruiting
Beijing Chaoyang Hospital, Capital Medical University
Beijing, Beijing Municipality, 100020
Zhen Jun Wang, M.D., 86-013601393711, wzhj611@163.com
Zhen Jun Wang
- Recruiting
Beijing daxing district people's hospital
Beijing, 100000
Baoju Qi, +8613810575512, yangyong_06681@163.com
About this study
Official title: Ligation of Intersphincteric Fistula Tract Versus Ligation of the Intersphincteric Fistula Tract Plus a Bioprosthetic Anal Fistula Plug Procedure in Patients With Transsphincteric Anal Fistula: Multicenter Prospective Randomized Trial
To validate the effect of Ligation of Intersphincteric Fistula Tract (LIFT) Versus LIFT-plug procedure for Anal Fistula Repair in 7 medical centers
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 in 7 medical centers.
- Conditions
- Anal Fistula, LIFT-plug, Healing Rate, Anal Function
- Being tested
- LIFT-plug technique
- Keywords
- anorectal fistula, LIFT-plug, complications of treatment, healing rate, anal function
- Medical subject headings
- Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIFT-plug techniqueProcedure or surgery
Small-intestine submucosa extracellular matrix plug was soaked in saline for 5-10 min, then placed into the intersphincteric groove and pulled through the curetted tract to the external opening. The plug was secured with a figure-of-eight 3/0 absorbable suture to the fistula opening in the external sphincter and ligated. Excess plug protruding from the external opening was trimmed flush with the skin without fixation. The wound was loosely closed with 2-3 interrupted 3/0 absorbable sutures
| Study group | Role | What they receive |
|---|---|---|
| LIFT-plug | Experimental | The LIFT-plug procedure was performed as followings. A portion of the fistula tract was excised from ei¬ther end within the intersphincteric space. One porcine small-intestine submucosa extracellular matrix plug was soaked in saline for 5-10 min, then placed into the intersphincteric groove and pulled through the curetted tract to the external opening. The plug was secured with a figure-of-eight 3/0 absorbable suture to the fistula opening in the external sphincter and ligated. Excess plug protruding from the external opening was trimmed flush with the skin without fixation. The wound was loosely closed with 2-3 interrupted 3/0 absorbable sutures. Receives: Procedure: LIFT-plug technique |
| LIFT | Experimental | The LIFT procedure was performe as followings. The curvilinear incision and dissection of the intersphincteric tract were made as in the LIFT-plug technique. After the tract was isolated, the tract was doubly-ligated and suture-ligated with absorbable sutures as close as possible to the lateral margin of the internal anal sphincter and the medial margin of the external anal sphincter. The tract was then divided between the two sutures. A portion of the fistula tract was excised after ligation of ei¬ther end within the intersphincteric space. The medial ligature was very close to the internal opening, and nearly obliterated the internal opening. The external opening was then enlarged to allow adequate drainage. The internal and external sphincters were then re-approximated, and the skin was closed loosely with interrupted 3/0 absorbable suture. Receives: Procedure: LIFT-plug technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing rate
the healing rate of two groups in 6 months postoperatively
Measured: 6 months postoperatively
healing time
the wound healing time from operation to healing
Measured: 6 months postoperatively
Secondary outcomes (2)
anal function
wexner score
Measured: 5 days, 2 weeks, 1 months, 3 months and 1 year postoperatively
pain score postoperatively
visual analog scale scores
Measured: 5 days, 2 weeks, 1 months, 3 months and 1 year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start1 Jan 2018
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (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
- Single blind
- Who is masked
- Participant
- Enrolment
- 384 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhen Jun Wang
- Sponsor type
- University, hospital or other
- Collaborators
- The Second Artillery General Hospital, Peking University Third Hospital, Beijing Anorectal Hospital, Beijing Luhe Hospital, Beijing Shuyi Hospital, People's Hospital of Beijing Daxing District
- Responsible party
- Sponsor-investigator, Zhen Jun Wang, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04310800
- Sponsor's protocol ID
- LIFT-plug 2020
- Other IDs
- 2018-1-2032
- Acronym
- LIFT 02
- Status last verified
- Mar 2020
- First submitted
- 13 Mar 2020
- Last updated
- 17 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ligation of Intersphincteric Fistula Tract Versus Ligation of the Intersphincteric Fistula Tract Plus a Bioprosthetic Anal Fistula Plug Procedure in Patients With Transsphincteric Anal Fistula: Multicenter Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT04310800
- Acronym / sponsor ID
- LIFT 02 / LIFT-plug 2020
- Conditions
- Anal Fistula, LIFT-plug, Healing Rate, Anal Function
- Keywords
- anorectal fistula, LIFT-plug, complications of treatment, healing rate, anal function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 384 participants (estimated)
- Lead sponsor
- Zhen Jun WangUniversity, hospital or other
- Collaborators
- The Second Artillery General Hospital, Peking University Third Hospital, Beijing Anorectal Hospital, Beijing Luhe Hospital, Beijing Shuyi Hospital, People's Hospital of Beijing Daxing District
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 17 Mar 2020 (actual)
- 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.
To validate the effect of Ligation of Intersphincteric Fistula Tract (LIFT) Versus LIFT-plug procedure for Anal Fistula Repair in 7 medical centers
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 in 7 medical centers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LIFT-plug | Experimental | Procedure: LIFT-plug techniqueThe LIFT-plug procedure was performed as followings. A portion of the fistula tract was excised from ei¬ther end within the intersphincteric space. One porcine small-intestine submucosa extracellular matrix plug was soaked in saline for 5-10 min, then placed into the intersphincteric groove and pulled through the curetted tract to the external opening. The plug was secured with a figure-of-eight 3/0 absorbable suture to the fistula opening in the external sphincter and ligated. Excess plug protruding from the external opening was trimmed flush with the skin without fixation. The wound was loosely closed with 2-3 interrupted 3/0 absorbable sutures. |
| LIFT | Experimental | Procedure: LIFT-plug techniqueThe LIFT procedure was performe as followings. The curvilinear incision and dissection of the intersphincteric tract were made as in the LIFT-plug technique. After the tract was isolated, the tract was doubly-ligated and suture-ligated with absorbable sutures as close as possible to the lateral margin of the internal anal sphincter and the medial margin of the external anal sphincter. The tract was then divided between the two sutures. A portion of the fistula tract was excised after ligation of ei¬ther end within the intersphincteric space. The medial ligature was very close to the internal opening, and nearly obliterated the internal opening. The external opening was then enlarged to allow adequate drainage. The internal and external sphincters were then re-approximated, and the skin was closed loosely with interrupted 3/0 absorbable suture. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- High transsphincteric fistula (involving > 30% of the external anal sphincter)
- Age between 18 and 70 years
- Chronic anal fistula with fistula tracts no more than 2
- No active sepsis or abscess
Key exclusion criteria (11 listed)
- Fistulas with active inflammation or purulence
- Fistulas related to tumor, Crohn's disease, tuberculosis or acquired immune deficiency syndrome
- Poorly controlled diabetes with fasting blood-glucose > 8mmol/L
- Preexisting incontinence
- Multiple fistula tracts > 2
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-plug techniqueSmall-intestine submucosa extracellular matrix plug was soaked in saline for 5-10 min, then placed into the intersphincteric groove and pulled through the curetted tract to the external opening. The plug was secured with a figure-of-eight 3/0 absorbable suture to the fistula opening in the external sphincter and ligated. Excess plug protruding from the external opening was trimmed flush with the skin without fixation. The wound was loosely closed with 2-3 interrupted 3/0 absorbable sutures | Procedure or surgery | LIFT, LIFT-plug |
Primary outcome
Healing rate
Time frame: 6 months postoperatively
the healing rate of two groups in 6 months postoperatively
healing time
Time frame: 6 months postoperatively
the wound healing time from operation to healing
2 secondary outcomes
anal function
Time frame: 5 days, 2 weeks, 1 months, 3 months and 1 year postoperatively
pain score postoperatively
Time frame: 5 days, 2 weeks, 1 months, 3 months and 1 year postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
- Individual participant dataSharing planned: Undecided
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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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LIFT-plug technique in people with Anal Fistula and LIFT-plug, run by Zhen Jun Wang at 7 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 4 inclusion and 11 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 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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.
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 Jinjie Cui, MD (+86 10 85231604, 913916215@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing rate (time frame: 6 months postoperatively). The study lists 2 primary outcomes in all. 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 17 Mar 2020.