LIFT-plug vs LIFT, a RCT Trial

Anal Fistula Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04310800
• Other study ID #: LIFT-plug 2020
• Secondary ID: 2018-1-2032
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2020
• Source: Beijing Chao Yang Hospital
• Contact: Jinjie Cui, MD
• Phone: +86 10 85231604
• Email: 913916215[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To validate the effect of Ligation of Intersphincteric Fistula Tract (LIFT) Versus LIFT-plug procedure for Anal Fistula Repair in 7 medical centers

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 information / eligibility

• Status: Recruiting
• Enrollment: 384
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Anal Fistula
• Anal Function
• Fistula
• Healing Rate
• LIFT-plug
• Rectal Fistula

Intervention

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

Locations

Country	Name	City	State
China	Beijing Anorectal Hospital	Beijing	Beijing
China	Beijing Chaoyang Hospital, Capital Medical University	Beijing	Beijing
China	Beijing daxing district people's hospital	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

Sponsors (7)

Lead Sponsor	Collaborator
Zhen Jun Wang	Beijing Anorectal Hospital, Beijing Luhe Hospital, Beijing Shuyi Hospital, Peking University Third Hospital, People’s Hospital of Beijing Daxing District, The Second Artillery General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healing rate	the healing rate of two groups in 6 months postoperatively	6 months postoperatively
Primary	healing time	the wound healing time from operation to healing	6 months postoperatively
Secondary	anal function	wexner score	5 days, 2 weeks, 1 months, 3 months and 1 year postoperatively
Secondary	pain score postoperatively	visual analog scale scores	5 days, 2 weeks, 1 months, 3 months and 1 year postoperatively