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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UNKNOWN
NA
80 participants
INTERVENTIONAL
2019-08-01
2020-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group 1
Patients diagnosed with anal fistula treated by laser closure of the tract
Laser closure of the anal fistula tract (FiLaC)
The FiLaC procedure was performed using a ceramic diode laser platform (12 watts, 1470-nm wavelength). The laser fiber was introduced into the fistula tract via the external orifice using the seldinger maneuver until the internal orifice was found. The fiber delivered laser energy homogenously at 3600, causing shrinkage of the fistula tract around the fiber while it was withdrawn at the speed of 1 mm/s
Group 2
Patients diagnosed with anal fistula treated by laser closure of the tract with an additional surgical technique as the closure of the internal orifice with a purse-string suture using 2-0 polyglactin
Laser closure of the anal fistula tract (FiLaC)
The FiLaC procedure was performed using a ceramic diode laser platform (12 watts, 1470-nm wavelength). The laser fiber was introduced into the fistula tract via the external orifice using the seldinger maneuver until the internal orifice was found. The fiber delivered laser energy homogenously at 3600, causing shrinkage of the fistula tract around the fiber while it was withdrawn at the speed of 1 mm/s
Internal orifice closure
Closure of internal orifice with a purse-string suture using 2-0 polyglactin suture material.
Interventions
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Laser closure of the anal fistula tract (FiLaC)
The FiLaC procedure was performed using a ceramic diode laser platform (12 watts, 1470-nm wavelength). The laser fiber was introduced into the fistula tract via the external orifice using the seldinger maneuver until the internal orifice was found. The fiber delivered laser energy homogenously at 3600, causing shrinkage of the fistula tract around the fiber while it was withdrawn at the speed of 1 mm/s
Internal orifice closure
Closure of internal orifice with a purse-string suture using 2-0 polyglactin suture material.
Eligibility Criteria
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Inclusion Criteria
* high anal fistulas
* recurrent anal fistulas
Exclusion Criteria
* multibranching anal fistulas
18 Years
ALL
No
Sponsors
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Surp Pırgiç Armenian Hospital
OTHER
Responsible Party
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Kursat Serin
Asistant Profesor
Locations
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Surp Pırgic AH
Istanbul, Zeytinburnu, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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Terzi MC, Agalar C, Habip S, Canda AE, Arslan NC, Obuz F. Closing Perianal Fistulas Using a Laser: Long-Term Results in 103 Patients. Dis Colon Rectum. 2018 May;61(5):599-603. doi: 10.1097/DCR.0000000000001038.
Wilhelm A. A new technique for sphincter-preserving anal fistula repair using a novel radial emitting laser probe. Tech Coloproctol. 2011 Dec;15(4):445-9. doi: 10.1007/s10151-011-0726-0. Epub 2011 Aug 16.
Ozturk E, Gulcu B. Laser ablation of fistula tract: a sphincter-preserving method for treating fistula-in-ano. Dis Colon Rectum. 2014 Mar;57(3):360-4. doi: 10.1097/DCR.0000000000000067.
Wilhelm A, Fiebig A, Krawczak M. Five years of experience with the FiLaC laser for fistula-in-ano management: long-term follow-up from a single institution. Tech Coloproctol. 2017 Apr;21(4):269-276. doi: 10.1007/s10151-017-1599-7. Epub 2017 Mar 7.
Other Identifiers
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2019-10
Identifier Type: -
Identifier Source: org_study_id
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