Extracellular Matrix Alteration Clinical Trial
Official title:
Ligation of Intersphincteric Fistula Tract (LIFT) Versus LIFT-plug Procedure for Anal Fistula Repair: a Multicenter, Randomized, Open-label, Parallel Controlled Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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