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

NCT ID: NCT01478139

Last Updated: 2013-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2013-11-30

Brief Summary

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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

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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.

Conditions

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Anorectal Fistula Extracellular Matrix Alteration

Keywords

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anorectal fistula acellular dermal matrix ligation of intersphincteric fistula tract ligation of intersphincteric fistula tract and plug complications of treatment recurrence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LIFT

Subjects randomized to this arm will receive the ligation of the intersphincteric fistula track (LIFT) procedure

Group Type EXPERIMENTAL

LIFT

Intervention Type PROCEDURE

Subjects randomized to this arm will receive the ligation of the intersphincteric fistula track (LIFT) procedure

LIFT-plug

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

Group Type EXPERIMENTAL

LIFT-plug

Intervention Type PROCEDURE

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

Interventions

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LIFT-plug

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

Intervention Type PROCEDURE

LIFT

Subjects randomized to this arm will receive the ligation of the intersphincteric fistula track (LIFT) procedure

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University Third Hospital

OTHER

Sponsor Role collaborator

Tianjin Third Central Hospital

OTHER

Sponsor Role collaborator

Xi'an Jiaotong University

OTHER

Sponsor Role collaborator

Shaanxi Provincial People's Hospital

OTHER

Sponsor Role collaborator

Zhen Jun Wang

OTHER

Sponsor Role lead

Responsible Party

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Zhen Jun Wang

Clinical Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Zhen Jun Wang, M.D.

Role: STUDY_CHAIR

Beijing Chao Yang Hospital

Locations

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Peking University Third Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Beijing Chaoyang Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status RECRUITING

Shaanxi Provincial People's Hospital

Xi’an, Shanxi, China

Site Status RECRUITING

Xi'an Jiaotong University College of Medicine

Xi’an, Shanxi, China

Site Status RECRUITING

Tianjin Third Central Hospital

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhen Jun Wang, M.D.

Role: CONTACT

Phone: 86-1085231604

Email: [email protected]

Li Hua Tian, M.D.

Role: CONTACT

Phone: 86-1085231217

Email: [email protected]

Facility Contacts

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Chao Wen Chen, M.D.

Role: primary

Zhen Jun Wang, M.D.

Role: primary

Xiao Qiang Wang, M.D.

Role: primary

Xiang Ming Che, M.D.

Role: primary

Wei Liang Song, M.D.

Role: primary

Other Identifiers

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LIFTplug-110212

Identifier Type: -

Identifier Source: org_study_id