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

NCT03690934 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2018-11-14

No results posted yet for this study

Summary

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

Conditions

  • Anal Fistula

Interventions

PROCEDURE

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 For obliteration, the fistula track is treated with a continuous slow retraction of the laser fibre withdrawn at a rate of approximately 1 cm per 2-3s.

PROCEDURE

Monopolar 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.

Sponsors & Collaborators

  • State Scientific Centre of Coloproctology, Russian Federation

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-23
Primary Completion
2020-08-31
Completion
2020-08-31

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03690934 on ClinicalTrials.gov