Back to resultsTreatment of Transsphicteric Fistula-in-ano by Method of Laser Thermoobliteration(FiLaC™).
Primary Purpose
Anal Fistula
Status
Unknown status
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Fistula-tract laser closure (FiLAC™)
Monopolar coagulation of fistulous tract
Sponsored by
About this trial
This is an interventional treatment trial for Anal Fistula
Eligibility Criteria
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
Sites / Locations
- State Scientific Centre of ColoproctologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Fistula-tract laser closure (FiLAC™)
Fistula monopolar cogulation
Arm Description
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.
The treatment technicque consists of monopolar coagulation of fistulous tract walls with suturing the internal fistulas opening.
Outcomes
Primary Outcome Measures
Rate of healing
healing
Secondary Outcome Measures
Full Information
NCT ID
NCT03690934
First Posted
September 12, 2018
Last Updated
November 13, 2018
Sponsor
State Scientific Centre of Coloproctology, Russian Federation
1. Study Identification
Unique Protocol Identification Number
NCT03690934
Brief Title
Treatment of Transsphicteric Fistula-in-ano by Method of Laser Thermoobliteration(FiLaC™).
Official Title
Randomized Conrtolled Study: Fistula Laser Closure (FiLaC™) vs Monopolar Coagulation for Treatment of Complex Anal Fistulae.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 23, 2017 (Actual)
Primary Completion Date
August 31, 2020 (Anticipated)
Study Completion Date
August 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
State Scientific Centre of Coloproctology, Russian Federation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anal Fistula
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fistula-tract laser closure (FiLAC™)
Arm Type
Experimental
Arm Description
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.
Arm Title
Fistula monopolar cogulation
Arm Type
Active Comparator
Arm Description
The treatment technicque consists of monopolar coagulation of fistulous tract walls with suturing the internal fistulas opening.
Intervention Type
Procedure
Intervention Name(s)
Fistula-tract laser closure (FiLAC™)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Monopolar coagulation of fistulous tract
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of healing
Description
healing
Time Frame
60 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ivan Kostarev, MD
Phone
+7-499-199-63-98
Email
djovani_80@mail.ru
Facility Information:
Facility Name
State Scientific Centre of Coloproctology
City
Moscow
ZIP/Postal Code
123423
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivan Kostarev, MD
12. IPD Sharing Statement
Learn more about this trial
Treatment of Transsphicteric Fistula-in-ano by Method of Laser Thermoobliteration(FiLaC™).
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