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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01478139
Other study ID # LIFTplug-110212
Secondary ID
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


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
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