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

Extracellular Matrix Alteration Clinical Trial

— LIFT-plug  

Official title:

Ligation of Intersphincteric Fistula Tract (LIFT) Versus LIFT-plug Procedure for Anal Fistula Repair: a Multicenter, Randomized, Open-label, Parallel Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01478139
• Other study ID #: LIFTplug-110212
• Status: Recruiting
• Phase: Phase 3
• First received: November 10, 2011
• Last updated: November 26, 2013
• Start date: February 2011
• Est. completion date: November 2013

Study information

• Verified date: November 2013
• Source: Beijing Chao Yang Hospital
• Contact: Zhen Jun Wang, M.D.
• Phone: 86-1085231604
• Email: wang3zj[@]sohu.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anorectal Fistula
• Extracellular Matrix Alteration
• Fistula
• Rectal Fistula

Intervention

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

Locations

Country	Name	City	State
China	Beijing Chaoyang Hospital, Capital Medical University	Beijing	Beijing
China	Peking University Third Hospital	Beijing	Beijing
China	Tianjin Third Central Hospital	Tianjin	Tianjin
China	Shaanxi Provincial People's Hospital	Xi'an	Shanxi
China	Xi'an Jiaotong University College of Medicine	Xi'an	Shanxi

Sponsors (5)

Lead Sponsor	Collaborator
Zhen Jun Wang	Peking University Third Hospital, Shaanxi Provincial People's Hospital, Tianjin Third Central Hospital, Xi’an Jiaotong University College of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healing time		1month, 3 month, 6 month postoperatively	No
Secondary	recurrence rate		1month, 3 month, 6 month postoperatively	No
Secondary	postoperative pain	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.	1month, 3 month, 6 month postoperatively	No
Secondary	fecal incontinence		1month, 3 month, 6 month postoperatively	No
Secondary	complication rates		1month, 3 month, 6 month postoperatively	No