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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
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 For obliteration, the fistula track is treated with a continuous slow retraction of the laser fibre withdrawn at a rate of approximately 1 cm per 2-3s.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.
State Scientific Centre of Coloproctology
Moscow, Russia
RECRUITINGRate of healing
healing
Time frame: 60 days
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