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LIFT-plug vs LIFT, a RCT Trial — LIFT 02  

Anal Fistula Clinical 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

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

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04310800
Study type Interventional
Source Beijing Chao Yang Hospital
Contact Jinjie Cui, MD
Phone +86 10 85231604
Email 913916215@qq.com
Status Recruiting
Phase N/A
Start date January 1, 2018
Completion date December 31, 2020
View Details
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