LIFT-plug vs LIFT, a RCT Trial
- Conditions
- LIFT-plugHealing RateAnal FistulaAnal Function
- Registration Number
- NCT04310800
- Lead Sponsor
- Zhen Jun Wang
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 384
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Healing rate 6 months postoperatively the healing rate of two groups in 6 months postoperatively
healing time 6 months postoperatively the wound healing time from operation to healing
- Secondary Outcome Measures
Name Time Method pain score postoperatively 5 days, 2 weeks, 1 months, 3 months and 1 year postoperatively visual analog scale scores
anal function 5 days, 2 weeks, 1 months, 3 months and 1 year postoperatively wexner score
Trial Locations
- Locations (7)
Beijing Anorectal Hospital
🇨🇳Beijing, Beijing, China
Beijing Luhe Hospital
🇨🇳Beijing, Beijing, China
Beijing shunyi district hospital
🇨🇳Beijing, Beijing, China
Peking University Third Hospital
🇨🇳Beijing, Beijing, China
Rocket force general hospital
🇨🇳Beijing, Beijing, China
Beijing Chaoyang Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Beijing daxing district people's hospital
🇨🇳Beijing, China
Beijing Anorectal Hospital🇨🇳Beijing, Beijing, ChinaYuru Zhang, M.D.Principal Investigator