Clinical trial NCT01478139: Ligation of Intersphincteric Fistula Tract (LIFT) Versus LIFT-plug Procedure for Anal Fistula Repair
Official title: Ligation of Intersphincteric Fistula Tract (LIFT) Versus LIFT-plug Procedure for Anal Fistula Repair: a Multicenter, Randomized, Open-label, Parallel Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Anorectal Fistula
Extracellular Matrix Alteration
Keywords: anorectal fistula
acellular dermal matrix
ligation of intersphincteric fistula tract
ligation of intersphincteric fistula tract and plug
complications of treatment
recurrence
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
Collaborators: name: Peking University Third Hospital
name: Tianjin Third Central Hospital
name: Xi'an Jiaotong University
name: Shaanxi Provincial People's Hospital
First posted: 2011-11-23
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Healing time
timeFrame: 1month, 3 month, 6 month postoperatively
Secondary outcomes:
measure: recurrence rate
timeFrame: 1month, 3 month, 6 month postoperatively
measure: postoperative pain
timeFrame: 1month, 3 month, 6 month postoperatively
measure: fecal incontinence
timeFrame: 1month, 3 month, 6 month postoperatively
measure: complication rates
timeFrame: 1month, 3 month, 6 month postoperatively
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Chaoyang Hospital, Capital Medical University
state: Beijing
city: Xi'an
country: China
facility: Shaanxi Provincial People's Hospital
state: Shanxi
city: Xi'an
country: China
facility: Xi'an Jiaotong University College of Medicine
state: Shanxi
city: Tianjin
country: China
facility: Tianjin Third Central Hospital
state: Tianjin
Study officials:
affiliation: Beijing Chao Yang Hospital
name: Zhen Jun Wang, M.D.
role: STUDY_CHAIR
References: