Treatment of Anal Fistula With Lasercoagulation

• Register: ClinicalTrials.gov
• Last refreshed on: 11 March 2024
• Main ID: NCT03017898
• Date of registration: 09/01/2017
• Prospective Registration: Yes
• Primary sponsor: Region Skane
• Public title: Treatment of Anal Fistula With Lasercoagulation
• Scientific title: Treatment of Anal Fistula With Laser Mediated Heat Coagulation Using Fistula Laser Closure (FiLaC)
• Date of first enrolment: March 3, 2017
• Target sample size: 52
• Recruitment status: Suspended
• URL: https://clinicaltrials.gov/ct2/show/NCT03017898
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Sweden

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Subject has been informed of the nature of the study, agrees to its provisions, and
has provided written informed consent.

2. Subject must be at least 18 years of age

3. Subject must have a verified anal fistula (by transanal ultrasound performed by
treating surgeon)

4. Subject must have a clean and infection-free fistula tract (no cavities seen on
transanal ultrasound)

5. Subject must be able to comply with study and study follow-up requirements.

Exclusion Criteria:

1. Subject with anorectal fistula due to Crohn's disease

2. Subject has an undrained abscess in fistula tract (cavities as seen on transanal
ultrasound)

3. Subject has fistula with side tracts (as seen on transanal ultrasound)

4. Subject is unable or unwilling to provide informed consent.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Fistula-In-Ano

Anal Fistula

Intervention(s)

Procedure: Laser Coagulation

Primary Outcome(s)

Healing [Time Frame: 12 months]

Secondary Outcome(s)

Infection [Time Frame: 12 months]

Incontinence [Time Frame: 12 months]

Secondary ID(s)

FiLaC-2016

Source(s) of Monetary Support

Please refer to primary and secondary sponsors