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

Not Applicable

• Conditions: Anal Fistula
• Interventions: Procedure: Fistula-tract laser closure (FiLAC™); Procedure: Monopolar coagulation of fistulous tract

• Registration Number: NCT03690934
• Lead Sponsor: State Scientific Centre of Coloproctology, Russian Federation

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2017-10-23
• Study First Submitted: 2018-09-12
• Study First Submitted QC: 2018-09-28
• Status Verified: 2018-10
• Study First Posted: 2018-10-01
• Last Update Submitted: 2018-11-13
• Last Update Posted: 2018-11-14
• Primary Completion: 2020-08-31
• Study Completion: 2020-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Informed consent to the study;
2. Patients with high transsphincteric fistula (>1/3), suprasphincteric fistula whithout abscesses;
3. The presence of a formed fistulous tract > 2 cm in length.

Exclusion Criteria

1. Suprasphincteric fistula with abscesses or infiltrates;
2. Extrasphincteric fistula;
3. Length of fistula tract < 2 cm;
4. The presence of sever scars in the region of internal fistula opening, wide fistula opening > 5 mm;
5. Crohn's fistulae

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fistula-tract laser closure (FiLAC™)	Fistula-tract laser closure (FiLAC™)	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.
Fistula monopolar cogulation	Monopolar coagulation of fistulous tract	The treatment technicque consists of monopolar coagulation of fistulous tract walls with suturing the internal fistulas opening.

Primary Outcome Measures

Name	Time	Method
Rate of healing	60 days	healing

Trial Locations

Locations (1)

State Scientific Centre of Coloproctology; 🇷🇺 Moscow, Russian Federation