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LIFT-plug vs LIFT, a RCT Trial (LIFT 02)

Primary Purpose

Anal Fistula, LIFT-plug, Healing Rate

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
LIFT-plug technique
Sponsored by
Zhen Jun Wang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anal Fistula focused on measuring anorectal fistula, LIFT-plug, complications of treatment, healing rate, anal function

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beijing Anorectal HospitalRecruiting
  • Beijing Luhe HospitalRecruiting
  • Beijing shunyi district hospitalRecruiting
  • Peking University Third HospitalRecruiting
  • Rocket force general hospitalRecruiting
  • Beijing Chaoyang Hospital, Capital Medical UniversityRecruiting
  • Beijing daxing district people's hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

LIFT-plug

LIFT

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Healing rate
the healing rate of two groups in 6 months postoperatively
healing time
the wound healing time from operation to healing

Secondary Outcome Measures

anal function
wexner score
pain score postoperatively
visual analog scale scores

Full Information

First Posted
March 13, 2020
Last Updated
March 13, 2020
Sponsor
Zhen Jun Wang
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
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1. Study Identification

Unique Protocol Identification Number
NCT04310800
Brief Title
LIFT-plug vs LIFT, a RCT Trial
Acronym
LIFT 02
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zhen Jun Wang
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anal Fistula, LIFT-plug, Healing Rate, Anal Function
Keywords
anorectal fistula, LIFT-plug, complications of treatment, healing rate, anal function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Randomization was performed on the day before surgery through sealed opaque envelopes containing the surgical method. The study was approved by the institutional review boards of the 7 hospitals.
Allocation
Randomized
Enrollment
384 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LIFT-plug
Arm Type
Experimental
Arm Description
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.
Arm Title
LIFT
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
LIFT-plug technique
Intervention Description
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
Primary Outcome Measure Information:
Title
Healing rate
Description
the healing rate of two groups in 6 months postoperatively
Time Frame
6 months postoperatively
Title
healing time
Description
the wound healing time from operation to healing
Time Frame
6 months postoperatively
Secondary Outcome Measure Information:
Title
anal function
Description
wexner score
Time Frame
5 days, 2 weeks, 1 months, 3 months and 1 year postoperatively
Title
pain score postoperatively
Description
visual analog scale scores
Time Frame
5 days, 2 weeks, 1 months, 3 months and 1 year postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jinjie Cui, MD
Phone
+86 10 85231604
Email
913916215@qq.com
Facility Information:
Facility Name
Beijing Anorectal Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuru Zhang, M.D.
First Name & Middle Initial & Last Name & Degree
Yuru Zhang, M.D.
Facility Name
Beijing Luhe Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guodan Jiang, M.D.
Email
caijianhua10020@163.com
First Name & Middle Initial & Last Name & Degree
Guodan JIANG, M.D.
Facility Name
Beijing shunyi district hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuefeng Xue, MD
Phone
8618510665770
Email
Min_liu12201@163.com
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chao Wen Chen, M.D.
Phone
86-013901038133
Email
ccw0070890@sina.com
First Name & Middle Initial & Last Name & Degree
Chao Wen Chen, M.D.
Facility Name
Rocket force general hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ke Zhao, M.D.
Phone
86-013370120126
First Name & Middle Initial & Last Name & Degree
Ke Zhao, M.D.
Facility Name
Beijing Chaoyang Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhen Jun Wang, M.D.
Phone
86-013601393711
Email
wzhj611@163.com
First Name & Middle Initial & Last Name & Degree
Zhen Jun Wang
Facility Name
Beijing daxing district people's hospital
City
Beijing
ZIP/Postal Code
100000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Baoju Qi
Phone
+8613810575512
Email
yangyong_06681@163.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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LIFT-plug vs LIFT, a RCT Trial

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