- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01478139
Ligation of Intersphincteric Fistula Tract (LIFT) Versus LIFT-plug Procedure for Anal Fistula Repair (LIFT-plug)
Ligation of Intersphincteric Fistula Tract (LIFT) Versus LIFT-plug Procedure for Anal Fistula Repair: a Multicenter, Randomized, Open-label, Parallel Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Zhen Jun Wang, M.D.
- Phone Number: 86-1085231604
- Email: wang3zj@sohu.com
Study Contact Backup
- Name: Li Hua Tian, M.D.
- Phone Number: 86-1085231217
- Email: cyky003@yahoo.com.cn
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100000
- Recruiting
- Peking University Third Hospital
-
Contact:
- Chao Wen Chen, M.D.
- Phone Number: 86-013901038133
- Email: ccw0070890@sina.com
-
Sub-Investigator:
- Chao Wen Chen, M.D.
-
Beijing, Beijing, China, 100020
- Recruiting
- Beijing Chaoyang Hospital, Capital Medical University
-
Contact:
- Zhen Jun Wang, M.D.
- Phone Number: 86-013601393711
- Email: wang3zj@sohu.com
-
-
Shanxi
-
Xi'an, Shanxi, China, 710000
- Recruiting
- Shaanxi Provincial People's Hospital
-
Contact:
- Xiao Qiang Wang, M.D.
- Phone Number: 86-013991966126
- Email: Xiaoqiangwang2008@yahoo.cn
-
Sub-Investigator:
- Xiao Qiang Wang, M.D.
-
Xi'an, Shanxi, China, 710000
- Recruiting
- Xi'an Jiaotong University College of Medicine
-
Contact:
- Xiang Ming Che, M.D.
- Phone Number: 86-018991232115
- Email: chexiang@mail.xjtu.edu.cn
-
Sub-Investigator:
- Xiang Ming Che, M.D.
-
-
Tianjin
-
Tianjin, Tianjin, China, 300000
- Recruiting
- Tianjin Third Central Hospital
-
Contact:
- Wei Liang Song, M.D.
- Phone Number: 86-015522242541
- Email: songwl2008@sina.com
-
Sub-Investigator:
- Wei Liang Song, M.D.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: LIFT
Subjects randomized to this arm will receive the ligation of the intersphincteric fistula track (LIFT) procedure
|
Subjects randomized to this arm will receive the ligation of the intersphincteric fistula track (LIFT) procedure
|
Experimental: LIFT-plug
Subjects randomized to this arm will receive the ligation of the intersphincteric fistula track and plug (LIFT-plug) procedure
|
Subjects randomized to this arm will receive the ligation of the intersphincteric fistula track and plug (LIFT-plug) procedure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Healing time
Time Frame: 1month, 3 month, 6 month postoperatively
|
1month, 3 month, 6 month postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
recurrence rate
Time Frame: 1month, 3 month, 6 month postoperatively
|
1month, 3 month, 6 month postoperatively
|
|
postoperative pain
Time Frame: 1month, 3 month, 6 month postoperatively
|
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
|
fecal incontinence
Time Frame: 1month, 3 month, 6 month postoperatively
|
1month, 3 month, 6 month postoperatively
|
|
complication rates
Time Frame: 1month, 3 month, 6 month postoperatively
|
1month, 3 month, 6 month postoperatively
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Zhen Jun Wang, M.D., Beijing Chao Yang Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LIFTplug-110212
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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