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.
1 other identifier
interventional
120
1 country
1
Brief Summary
This is a randomized, controlled, parallel study to compare the results of treatment for patients with transsphincteric fistulas-in-ano.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 23, 2017
CompletedFirst Submitted
Initial submission to the registry
September 12, 2018
CompletedFirst Posted
Study publicly available on registry
October 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2020
CompletedNovember 14, 2018
October 1, 2018
2.9 years
September 12, 2018
November 13, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Rate of healing
healing
60 days
Study Arms (2)
Fistula-tract laser closure (FiLAC™)
EXPERIMENTALThe 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.
Fistula monopolar cogulation
ACTIVE COMPARATORThe treatment technicque consists of monopolar coagulation of fistulous tract walls with suturing the internal fistulas opening.
Interventions
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 For obliteration, the fistula track is treated with a continuous slow retraction of the laser fibre withdrawn at a rate of approximately 1 cm per 2-3s.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
State Scientific Centre of Coloproctology
Moscow, 123423, Russia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2018
First Posted
October 1, 2018
Study Start
October 23, 2017
Primary Completion
August 31, 2020
Study Completion
August 31, 2020
Last Updated
November 14, 2018
Record last verified: 2018-10