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.

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

Study Overview

• Status: Unknown
• Conditions: Anal Fistula
• Intervention / Treatment: Procedure: Fistula-tract laser closure (FiLAC™); Procedure: Monopolar coagulation of fistulous tract

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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 123423
    • Recruiting
    • State Scientific Centre of Coloproctology
    • Contact: Ivan Kostarev, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 86 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of healing	healing	60 days

Collaborators and Investigators

• Sponsor: State Scientific Centre of Coloproctology, Russian Federation

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2017
• Primary Completion (Anticipated): August 31, 2020
• Study Completion (Anticipated): August 31, 2020

Study Registration Dates

• First Submitted: September 12, 2018
• First Submitted That Met QC Criteria: September 28, 2018
• First Posted (Actual): October 1, 2018

Study Record Updates

• Last Update Posted (Actual): November 14, 2018
• Last Update Submitted That Met QC Criteria: November 13, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Rectal Diseases; Intestinal Fistula; Digestive System Fistula; Fistula; Rectal Fistula
• Other Study ID Numbers: 74

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No