- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04310800
LIFT-plug vs LIFT, a RCT Trial (LIFT 02)
March 13, 2020 updated by: Zhen Jun Wang
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
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
384
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jinjie Cui, MD
- Phone Number: +86 10 85231604
- Email: 913916215@qq.com
Study Locations
-
-
-
Beijing, China, 100000
- Recruiting
- Beijing Daxing District People's Hospital
-
Contact:
- Baoju Qi
- Phone Number: +8613810575512
- Email: yangyong_06681@163.com
-
-
Beijing
-
Beijing, Beijing, China, 100000
- Recruiting
- Peking University Third Hospital
-
Contact:
- Chao Wen Chen, M.D.
- Phone Number: 86-013901038133
- Email: ccw0070890@sina.com
-
Sub-Investigator:
- Chao Wen Chen, M.D.
-
Beijing, Beijing, China, 100020
- Recruiting
- Beijing Chaoyang Hospital, Capital Medical University
-
Contact:
- Zhen Jun Wang, M.D.
- Phone Number: 86-013601393711
- Email: wzhj611@163.com
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Beijing, Beijing, China, 100000
- Recruiting
- Beijing Anorectal Hospital
-
Contact:
- Yuru Zhang, M.D.
-
Principal Investigator:
- Yuru Zhang, M.D.
-
Beijing, Beijing, China, 100000
- Recruiting
- Beijing luhe hospital
-
Contact:
- Guodan Jiang, M.D.
- Email: caijianhua10020@163.com
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Principal Investigator:
- Guodan JIANG, M.D.
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Beijing, Beijing, China, 100000
- Recruiting
- Beijing Shunyi District Hospital
-
Contact:
- Xuefeng Xue, MD
- Phone Number: 8618510665770
- Email: Min_liu12201@163.com
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Beijing, Beijing, China, 100000
- Recruiting
- Rocket force general hospital
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Contact:
- Ke Zhao, M.D.
- Phone Number: 86-013370120126
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Principal Investigator:
- Ke Zhao, M.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 68 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: LIFT-plug
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.
|
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
|
Experimental: LIFT
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.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Healing rate
Time Frame: 6 months postoperatively
|
the healing rate of two groups in 6 months postoperatively
|
6 months postoperatively
|
healing time
Time Frame: 6 months postoperatively
|
the wound healing time from operation to healing
|
6 months postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
anal function
Time Frame: 5 days, 2 weeks, 1 months, 3 months and 1 year postoperatively
|
wexner score
|
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
|
visual analog scale scores
|
5 days, 2 weeks, 1 months, 3 months and 1 year postoperatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2018
Primary Completion (Anticipated)
December 31, 2020
Study Completion (Anticipated)
December 31, 2020
Study Registration Dates
First Submitted
March 13, 2020
First Submitted That Met QC Criteria
March 13, 2020
First Posted (Actual)
March 17, 2020
Study Record Updates
Last Update Posted (Actual)
March 17, 2020
Last Update Submitted That Met QC Criteria
March 13, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LIFT-plug 2020
- 2018-1-2032 (Other Grant/Funding Number: the Capital Health Research and Development of Special)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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