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

State Scientific Centre of Coloproctology, Russian Federation

Status: Unknown

Conditions: Anal Fistula

Treatments: Procedure: Fistula-tract laser closure (FiLAC™); Procedure: Monopolar coagulation of fistulous tract

Study type: Interventional

Funder types: Other

Identifiers

NCT03690934

74

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Fistula-tract laser closure (FiLAC™)

Experimental group

Description:

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.

Treatment:

Procedure: Fistula-tract laser closure (FiLAC™)

Fistula monopolar cogulation

Active Comparator group

Description:

The treatment technicque consists of monopolar coagulation of fistulous tract walls with suturing the internal fistulas opening.

Treatment:

Procedure: Monopolar coagulation of fistulous tract