Treatment of Anal Fistula With Lasercoagulation

Study Overview
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Brief Summary
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The purpose of this study is to determine whether treatment with laser coagulation is an effective and safe treatment option for patients with anal fistula

Detailed Description
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Treatment of anal fistula remains a challenge - the only truly effective treatment available (fistulotomy) involves very high rates of anal incontinence if performed on the majority of patients, and a vast number of alternative, sphincter-preserving treatments have been developed and evaluated in the past decades. The treatment of anal fistula with laser coagulation causes the fistula to collapse and subsequently heal, without having to add any external materials. The available published studies show that the treatment is safe regarding infection and incontinence, and that a majority of the patients treated show complete healing. There is however a need for more prospective studies to ascertain these preliminary facts.

Official Title
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Treatment of Anal Fistula With Laser Mediated Heat Coagulation Using Fistula Laser Closure (FiLaC)

Conditions
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Fistula-In-Ano, Anal Fistula

Intervention / Treatment
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* Procedure: Laser Coagulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent. Subject must be at least 18 years of age Subject must have a verified anal fistula (by transanal ultrasound performed by treating surgeon) Subject must have a clean and infection-free fistula tract (no cavities seen on transanal ultrasound) Subject must be able to comply with study and study follow-up requirements. Exclusion Criteria: Subject with anorectal fistula due to Crohn's disease Subject has an undrained abscess in fistula tract (cavities as seen on transanal ultrasound) Subject has fistula with side tracts (as seen on transanal ultrasound) Subject is unable or unwilling to provide informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laser coagulation<br>Treatment of anal fistulae meeting the inclusion criteria | Procedure: Laser Coagulation<br>* Laser coagulation of anal fistula<br>* Other names: Fistula Laser Closure (FiLaC);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healing | Fistula closure success at 12 months is defined as complete healing of the fistula tract and external opening at clinical examination and on a transanal ultrasound performed by the examining surgeon (yes/no). | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infection | Rate of infection i.e. formation of abcess during the time of healing or thereafter within the first year of treatment. | 12 months | 
| Incontinence | Presence of fecal incontinence as described by the patient | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FiLaC, Fistula Laser Closure, Laser Coagulation