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

Not Applicable

• Conditions: Anal Fistula

• Registration Number: NCT03690934
• Lead Sponsor: State Scientific Centre of Coloproctology, Russian Federation

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.

Study Timeline

• Study Start: 2017-10-23
• Study First Submitted: 2018-09-12
• Study First Submitted QC: 2018-09-28
• Status Verified: 2018-10
• Study First Posted: 2018-10-01
• Last Update Submitted: 2018-11-13
• Last Update Posted: 2018-11-14
• Primary Completion: 2020-08-31
• Study Completion: 2020-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Rate of healing	60 days	healing

Trial Locations

Locations (1)

State Scientific Centre of Coloproctology; 🇷🇺 Moscow, Russian Federation