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

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: Anal Fistula; LIFT-plug; Healing Rate; Anal Function
• Intervention / Treatment: Procedure: LIFT-plug technique

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

• Study Contact: Name: Jinjie Cui, MD; Phone Number: +86 10 85231604; Email: 913916215@qq.com

Study Locations

• China
  • 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
    • 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
      • Principal Investigator: Guodan JIANG, M.D.
    • Beijing, Beijing, China, 100000
      • Recruiting
      • Beijing Shunyi District Hospital
      • Contact: Xuefeng Xue, MD; Phone Number: 8618510665770; Email: Min_liu12201@163.com
    • Beijing, Beijing, China, 100000
      • Recruiting
      • Rocket force general hospital
      • Contact: Ke Zhao, M.D.; Phone Number: 86-013370120126
      • Principal Investigator: Ke Zhao, M.D.

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

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.	Procedure: LIFT-plug technique; 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.	Procedure: LIFT-plug technique; 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	the healing rate of two groups in 6 months postoperatively	6 months postoperatively
healing time	the wound healing time from operation to healing	6 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
anal function	wexner score	5 days, 2 weeks, 1 months, 3 months and 1 year postoperatively
pain score postoperatively	visual analog scale scores	5 days, 2 weeks, 1 months, 3 months and 1 year postoperatively

Collaborators and Investigators

• Sponsor: Zhen Jun Wang
• Collaborators: Peking University Third Hospital; Beijing Luhe Hospital; Beijing Shuyi Hospital; The Second Artillery General Hospital; Beijing Anorectal Hospital; People's Hospital of Beijing Daxing District

Study record dates

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

• Keywords: anorectal fistula; complications of treatment; healing rate; LIFT-plug; anal function
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Rectal Diseases; Intestinal Fistula; Digestive System Fistula; Fistula; Rectal Fistula
• 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