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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03690934

Enrollment

120

Registered

2018-10-01

Start date

2017-10-23

Completion date

2020-08-31

Last updated

2018-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anal Fistula

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.

Interventions

PROCEDUREFistula-tract laser closure (FiLAC™)

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 For obliteration, the ﬁstula track is treated with a continuous slow retraction of the laser ﬁbre withdrawn at a rate of approximately 1 cm per 2-3s.

PROCEDUREMonopolar coagulation of fistulous tract

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Assignment

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Rate of healing	60 days	healing

Countries

Russia

Contacts

Primary ContactIvan Kostarev, MD

djovani_80@mail.ru+7-499-199-63-98

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026