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

Sponsor

State Scientific Centre of Coloproctology, Russian Federation (Other)

Overall Status

Unknown status

CT.gov ID

NCT03690934

Collaborator

(none)

120

Enrollment

Location

Arms

34.3

Anticipated Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Anal Fistula	Procedure: Fistula-tract laser closure (FiLAC™) Procedure: Monopolar coagulation of fistulous tract	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

AssignmentAssignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 23, 2017

Anticipated Primary Completion Date :

Aug 31, 2020

Anticipated Study Completion Date :

Aug 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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 For obliteration, the ﬁstula track is treated with a continuous slow retraction of the laser ﬁbre withdrawn at a rate of approximately 1 cm per 2-3s.
Active Comparator: Fistula monopolar cogulation The treatment technicque consists of monopolar coagulation of fistulous tract walls with suturing the internal fistulas opening.	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.

Arm

Intervention/Treatment

Experimental: 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.

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.

Active Comparator: Fistula monopolar cogulation

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

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.

Outcome Measures

Primary Outcome Measures

Rate of healing [60 days]
healing

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	State Scientific Centre of Coloproctology	Moscow		Russian Federation	123423

Sponsors and Collaborators

State Scientific Centre of Coloproctology, Russian Federation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

State Scientific Centre of Coloproctology, Russian Federation

ClinicalTrials.gov Identifier:

NCT03690934

Other Study ID Numbers:

First Posted:

Oct 1, 2018

Last Update Posted:

Nov 14, 2018

Last Verified:

Oct 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Rectal Fistula

Fistula

Study Results

No Results Posted as of Nov 14, 2018