An interventional study of Fistula-tract laser closure (FiLAC™) and Monopolar coagulation of fistulous tract in Anal Fistula, sponsored by State Scientific Centre of Coloproctology, Russian Federation. Status unknown at 1 site in Russian Federation. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-11-14.
Sponsored by State Scientific Centre of Coloproctology, Russian Federation · Not applicable, Interventional, and Treatment
This is a randomized, controlled, parallel study to compare the results of treatment for patients with transsphincteric fistulas-in-ano.
We are planning to eroll 120 patients in this study,the duration of the stady be 3 years. Each of two groups will include 60 people. Pationts in the first group will be assigned to get treatment of the fistula-in-ano by laser thermo-obliteration (FiLAC™), patietns of the second group will forego monopolar coagulation of the fistulas tract with suturing the internal fistulas opening.
189 studies on the registry are indexed under Rectal Fistula; 41 are open to participants now.
This study's planned enrollment of 120 is above the median of 68 across 130 interventional studies indexed under Rectal Fistula.
Browse Rectal Fistula studies →State Scientific Centre of Coloproctology, Russian Federation is the lead sponsor of 25 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
The treatment technique consists of laser coagulation of fistulous tract walls with a diode laser with a wavelength of 1470 nm, which leads to thermo-obliteration of the fistulous tract.
Procedure: Fistula-tract laser closure (FiLAC™)
The treatment technicque consists of monopolar coagulation of fistulous tract walls with suturing the internal fistulas opening.
Procedure: Monopolar coagulation of fistulous tract
The procedure was performed with a diode laser platform emitting laser energy of 15 W at a wavelength of 1470 nm by means of a radial fiber. For obliteration, the fistula track is treated with a continuous slow retraction of the laser fibre withdrawn at a rate of approximately 1 cm per 2-3s.
The procedure was performed with a monopolar coagulator platform emitting monopolar coagulation. For obliteration, the fistula track is treated with a continuous slow retraction of the monopolar energy with suturing the internal fistulas opening.
Rate of healing
healing
Time frame: 60 days
This study is status unknown, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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State Scientific Centre of Coloproctology, Russian Federation