Ligation of Intersphincteric Fistula Tract (LIFT) Versus LIFT-plug Procedure for Anal Fistula Repair
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Anorectal Fistula Extracellular Matrix Alteration |
Procedure: LIFT-plug Procedure: LIFT |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Ligation of Intersphincteric Fistula Tract (LIFT) Versus LIFT-plug Procedure for Anal Fistula Repair: a Multicenter, Randomized, Open-label, Parallel Controlled Trial |
- The primary outcome measure of this study will be to compare the rate of fistula closure and healing time between the ligation of the intersphincteric fistula track (LIFT) and the LIFT-plug procedure [ Time Frame: 6 month postoperatively ] [ Designated as safety issue: No ]
- recurrence rate [ Time Frame: 1month, 3 month, 6 month postoperatively ] [ Designated as safety issue: No ]
- postoperative pain [ Time Frame: 1month, 3 month, 6 month postoperatively ] [ Designated as safety issue: No ]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 [ Time Frame: 1month, 3 month, 6 month postoperatively ] [ Designated as safety issue: No ]
- complication rates [ Time Frame: 1month, 3 month, 6 month postoperatively ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 240 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | February 2013 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: LIFT
Subjects randomized to this arm will receive the ligation of the intersphincteric fistula track (LIFT) procedure
|
Procedure: LIFT
Subjects randomized to this arm will receive the ligation of the intersphincteric fistula track (LIFT) procedure
Other Name: LIFT
|
|
Experimental: LIFT-plug
Subjects randomized to this arm will receive the ligation of the intersphincteric fistula track and plug (LIFT-plug) procedure
|
Procedure: LIFT-plug
Subjects randomized to this arm will receive the ligation of the intersphincteric fistula track and plug (LIFT-plug) procedure
Other Name: LIFT-plug
|
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| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Zhen Jun Wang, M.D. | 86-1085231604 | wang3zj@sohu.com |
| Contact: Li Hua Tian, M.D. | 86-1085231217 | cyky003@yahoo.com.cn |
| China, Beijing | |
| Beijing Chaoyang Hospital, Capital Medical University | Recruiting |
| Beijing, Beijing, China, 100020 | |
| Contact: Zhen Jun Wang, M.D. 86-013601393711 wang3zj@sohu.com | |
| Principal Investigator: Zhen Jun Wang | |
| Peking University Third Hospital | Recruiting |
| Beijing, Beijing, China, 100000 | |
| Contact: Chao Wen Chen, M.D. 86-013901038133 ccw0070890@sina.com | |
| Sub-Investigator: Chao Wen Chen, M.D. | |
| China, Shan Xi | |
| Xi'an Jiaotong University College of Medicine | Recruiting |
| Xi'an, Shan Xi, China, 710000 | |
| Contact: Xiang Ming Che, M.D. 86-018991232115 chexiang@mail.xjtu.edu.cn | |
| Sub-Investigator: Xiang Ming Che, M.D. | |
| Shaanxi Provincial People's Hospital | Recruiting |
| Xi'an, Shan Xi, China, 710000 | |
| Contact: Xiao Qiang Wang, M.D. 86-013991966126 Xiaoqiangwang2008@yahoo.cn | |
| Sub-Investigator: Xiao Qiang Wang, M.D. | |
| China, Tianjin | |
| Tianjin Third Central Hospital | Recruiting |
| Tianjin, Tianjin, China, 300000 | |
| Contact: Wei Liang Song, M.D. 86-015522242541 songwl2008@sina.com | |
| Sub-Investigator: Wei Liang Song, M.D. | |
| Study Chair: | Zhen Jun Wang, M.D. | Beijing Chaoyang Hospital, Capital Medical University |
More Information
No publications provided
| Responsible Party: | Zhen Jun Wang, Director and Clinical Professor, Beijing Chao Yang Hospital |
| ClinicalTrials.gov Identifier: | NCT01478139 History of Changes |
| Other Study ID Numbers: | LIFTplug-110212 |
| Study First Received: | November 10, 2011 |
| Last Updated: | November 22, 2011 |
| Health Authority: | China: Ministry of Health |
Keywords provided by Beijing Chao Yang Hospital:
|
anorectal fistula acellular dermal matrix ligation of intersphincteric fistula tract |
ligation of intersphincteric fistula tract and plug complications of treatment recurrence |
Additional relevant MeSH terms:
|
Fistula Rectal Fistula Pathological Conditions, Anatomical Intestinal Fistula Digestive System Fistula |
Digestive System Diseases Intestinal Diseases Gastrointestinal Diseases Rectal Diseases |
ClinicalTrials.gov processed this record on May 19, 2013