Treatment of Transsphicteric Fistula-in-ano by Method of Laser Thermoobliteration(FiLaC™).

Study Overview
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Brief Summary
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This is a randomized, controlled, parallel study to compare the results of treatment for patients with transsphincteric fistulas-in-ano.

Detailed Description
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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.

Official Title
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Randomized Conrtolled Study: Fistula Laser Closure (FiLaC™) vs Monopolar Coagulation for Treatment of Complex Anal Fistulae.

Conditions
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Anal Fistula

Intervention / Treatment
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* Procedure: Fistula-tract laser closure (FiLAC™)
* Procedure: Monopolar coagulation of fistulous tract


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent to the study; Patients with high transsphincteric fistula (>1/3), suprasphincteric fistula whithout abscesses; The presence of a formed fistulous tract > 2 cm in length. Exclusion Criteria: Suprasphincteric fistula with abscesses or infiltrates; Extrasphincteric fistula; Length of fistula tract < 2 cm; The presence of sever scars in the region of internal fistula opening, wide fistula opening > 5 mm; Crohn's fistulae

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fistula-tract laser closure (FiLAC™)<br>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™)<br>* 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.<br>|
| Active Comparator: Fistula monopolar cogulation<br>The treatment technicque consists of monopolar coagulation of fistulous tract walls with suturing the internal fistulas opening. | Procedure: Monopolar coagulation of fistulous tract<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of healing | healing | 60 days |