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

Anal Fistula Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03690934
• Other study ID #: 74
• Status: Recruiting
• Phase: N/A
• Start date: October 23, 2017
• Est. completion date: August 31, 2020

Study information

• Verified date: October 2018
• Source: State Scientific Centre of Coloproctology, Russian Federation
• Contact: Ivan Kostarev, MD
• Phone: +7-499-199-63-98
• Email: djovani_80[@]mail.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: August 31, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Anal Fistula
• Fistula
• Rectal Fistula

Intervention

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 ?ber. For obliteration, the ?stula track is treated with a continuous slow retraction of the laser ?bre withdrawn at a rate of approximately 1 cm per 2-3s.
• Monopolar coagulation of fistulous tract
The procedure was performed with a monopolar coagulator platform emitting monopolar coagulation. For obliteration, the ?stula track is treated with a continuous slow retraction of the monopolar energy with suturing the internal fistulas opening.

Locations

Country	Name	City	State
Russian Federation	State Scientific Centre of Coloproctology	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
State Scientific Centre of Coloproctology, Russian Federation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of healing	healing	60 days