Status:
UNKNOWN
Ligation of Intersphincteric Fistula Tract (LIFT) Versus LIFT-plug Procedure for Anal Fistula Repair
Lead Sponsor:
Zhen Jun Wang
Collaborating Sponsors:
Peking University Third Hospital
Tianjin Third Central Hospital
Conditions:
Anorectal Fistula
Extracellular Matrix Alteration
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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 recur...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2013
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT01478139
Start Date
February 1 2011
End Date
November 1 2013
Last Update
November 28 2013
Active Locations (5)
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1
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100000
2
Beijing Chaoyang Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100020
3
Shaanxi Provincial People's Hospital
Xi’an, Shanxi, China, 710000
4
Xi'an Jiaotong University College of Medicine
Xi’an, Shanxi, China, 710000