Ligation of Intersphincteric Fistula Tract (LIFT) Versus LIFT-plug Procedure for Anal Fistula Repair

Phase 3

• Conditions: Anorectal Fistula; Extracellular Matrix Alteration
• Interventions: Procedure: LIFT-plug; Procedure: LIFT

• Registration Number: NCT01478139
• Lead Sponsor: Zhen Jun Wang

Brief Summary

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.

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.

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-11-10
• Study First Submitted QC: 2011-11-22
• Study First Posted: 2011-11-23
• Status Verified: 2013-11
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Last Update Submitted: 2013-11-26
• Last Update Posted: 2013-11-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• Male or female subjects over eighteen years old or less than 65 years old.
• Able to understand and provide informed consent or have a legally authorized representative capable of providing consent.
• Clinical diagnosis of primary anal fistula categorized as trans-sphincteric fistula tract determined to be of cryptoglandular origin (primary or recurrent).

Exclusion Criteria

• Presence of horseshoe fistula.
• History of immunosuppression therapy/treatment within previous six months.
• Fistulas with active abscess, infection, or acute inflammation
• History of Choron's Disease
• History of Ulcerative Colitis
• History of HIV or other immune system disease
• History of collagen disease
• History of radiation to the anorectal region
• Allergies to pig tissue or pig products
• Religious or cultural objection to the use of pig tissue

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LIFT-plug	LIFT-plug	Subjects randomized to this arm will receive the ligation of the intersphincteric fistula track and plug (LIFT-plug) procedure
LIFT	LIFT	Subjects randomized to this arm will receive the ligation of the intersphincteric fistula track (LIFT) procedure

Primary Outcome Measures

Name	Time	Method
Healing time	1month, 3 month, 6 month postoperatively

Secondary Outcome Measures

Name	Time	Method
postoperative pain	1month, 3 month, 6 month postoperatively	The methodology used for the evaluation of postoperative perineal pain severity and relief, is the visual analogue scale (VAS) (1-10). We considered positive a VAS \> 4.
fecal incontinence	1month, 3 month, 6 month postoperatively
recurrence rate	1month, 3 month, 6 month postoperatively
complication rates	1month, 3 month, 6 month postoperatively

Trial Locations

Locations (5)

Xi'an Jiaotong University College of Medicine; 🇨🇳 Xi'an, Shanxi, China

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Chaoyang Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Shaanxi Provincial People's Hospital; 🇨🇳 Xi'an, Shanxi, China

Tianjin Third Central Hospital; 🇨🇳 Tianjin, Tianjin, China