Clinical trial NCT04310800: LIFT-plug vs LIFT, a RCT Trial
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
Overall status: UNKNOWN
Phase: NA
Conditions: Anal Fistula
LIFT-plug
Healing Rate
Anal Function
Keywords: anorectal fistula
LIFT-plug
complications of treatment
healing rate
anal function
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
Collaborators: name: The Second Artillery General Hospital
name: Peking University Third Hospital
name: Beijing Anorectal Hospital
name: Beijing Luhe Hospital
name: Beijing Shuyi Hospital
name: People's Hospital of Beijing Daxing District
First posted: 2020-03-17
Enrollment: 384
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Healing rate
timeFrame: 6 months postoperatively
measure: healing time
timeFrame: 6 months postoperatively
Secondary outcomes:
measure: anal function
timeFrame: 5 days, 2 weeks, 1 months, 3 months and 1 year postoperatively
measure: pain score postoperatively
timeFrame: 5 days, 2 weeks, 1 months, 3 months and 1 year postoperatively
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anorectal Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Luhe Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing shunyi district hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Beijing
country: China
facility: Rocket force general hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Chaoyang Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing daxing district people's hospital
Study officials:
References: