Anal Fistulae Internal Opening Closure by OTSC Clip After Video Assisted Tract Fulguration
NCT ID: NCT06243302
Last Updated: 2024-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
60 participants
OBSERVATIONAL
2014-09-30
2024-04-01
Brief Summary
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Detailed Description
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Ablating the fistula tract by laser or diathermy has been in use for a long time. Recently a rigid thin camera to visualize all side tracts and branches for ablating them under direct vision has also been in use especially in Europe. Recently, closing the internal opening after ablating the fistula tract was reported to offer higher success rates for healing with less recurrence. The success rate was higher when the opening was closed by a stapler device.
Our aim in this study is to use o novel technique by using OTSC clip for water tight closure of the internal fistula opening after diathermy ablation of the tract under direct vision and compare the healing and recurrence rates with other methods.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Treatment Arm
VAAFT followed by OTSC clip inserted to close the inner opening of the anal fistula
OTSC Closure After VAAFT
Under general anesthesia,the fistulas will be drained at least for 8 weeks. Then a video camera will be inserted through the external opening to fulgurate the fistula tract under direct vision. Finally the internal fistula opening will be closed water tight by a circular clip. The patients will be followed up for complications as well as short and long term recurrences
Interventions
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OTSC Closure After VAAFT
Under general anesthesia,the fistulas will be drained at least for 8 weeks. Then a video camera will be inserted through the external opening to fulgurate the fistula tract under direct vision. Finally the internal fistula opening will be closed water tight by a circular clip. The patients will be followed up for complications as well as short and long term recurrences
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
16 Years
75 Years
ALL
No
Sponsors
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Ankara University
OTHER
Responsible Party
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I Ethem Gecim
Prof Dr
Locations
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Ankara University Hospital,Dept of Surgery
Cebeci, Ankara, Turkey (Türkiye)
Countries
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References
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Meinero P, Mori L, Gasloli G. Video-assisted anal fistula treatment: a new concept of treating anal fistulas. Dis Colon Rectum. 2014 Mar;57(3):354-9. doi: 10.1097/DCR.0000000000000082.
Other Identifiers
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KRKAP-002
Identifier Type: -
Identifier Source: org_study_id
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