Laser Closure of Anal Fistula (FiLaC)

Study Overview
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Brief Summary
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Laser closure of the perianal fistula is the minimally invasive and low complication rate procedure which is a life-saving way for complex fistulas, preserving anal sphincter injury. Unfortunately, wide range success rate reported before (30-80%), the investigators are searching to reach better rates. Internal closure of the fistula orifice offered by some authors. The investigators are aimed to identify the efficiency of this.

Detailed Description
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Despite the developments in the surgical field, the treatment of anal fistula is still a challenging problem, especially in complex, transsphincteric cases. The surgical treatment aims to avoid recurrences and also to preserve normal sphincter functions. The FiLaC procedure was recently reported non-invasive technique in perianal fistulas for treatment and preserving anal sphincter function with a good success rate. In 2018, one of our colleagues published a 40% complete healing rate by using only FiLaC technique in 103 consecutive perianal fistula patients (Prof. Cem Terzi). Some authors advocated that the closure of the internal orifice increasing the success rate. Therefore, the investigators decided to modify the surgical technique focusing closure of the internal opening associated with the FiLaC procedure.

Official Title
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Laser Closure of Anal Fistula (FiLaC); Do we Need to Close Internal Orifice?

Conditions
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Anal Fistula, Fistula in Ano, Sphincter Ani Incontinence

Intervention / Treatment
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* Procedure: Laser closure of the anal fistula tract (FiLaC)
* Procedure: Internal orifice closure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: complex anal fistula high anal fistulas recurrent anal fistulas Exclusion Criteria: superficial anal fistulas multibranching anal fistulas

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The FiLaC procedure was performed using a ceramic diode laser platform (12 watts, 1470-nm wavelength). The laser fiber was introduced into the fistula tract via the external orifice using the seldinger maneuver until the internal orifice was found. The fiber delivered laser energy homogenously at 3600, causing shrinkage of the fistula tract around the fiber while it was withdrawn at the speed of 1 mm/s (2). We planned to randomized patients in two groups. Group 1) FiLaC closure of the tract, group 2) FiLaC closure of the tract with an additional surgical technique as the closure of the internal orifice with a purse-string suture using 2-0 polyglactin (VicrylR).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group 1<br>Patients diagnosed with anal fistula treated by laser closure of the tract | Procedure: Laser closure of the anal fistula tract (FiLaC)<br>* The FiLaC procedure was performed using a ceramic diode laser platform (12 watts, 1470-nm wavelength). The laser fiber was introduced into the fistula tract via the external orifice using the seldinger maneuver until the internal orifice was found. The fiber delivered laser energy homogenously at 3600, causing shrinkage of the fistula tract around the fiber while it was withdrawn at the speed of 1 mm/s<br>|
| Other: Group 2<br>Patients diagnosed with anal fistula treated by laser closure of the tract with an additional surgical technique as the closure of the internal orifice with a purse-string suture using 2-0 polyglactin | Procedure: Laser closure of the anal fistula tract (FiLaC)<br>* The FiLaC procedure was performed using a ceramic diode laser platform (12 watts, 1470-nm wavelength). The laser fiber was introduced into the fistula tract via the external orifice using the seldinger maneuver until the internal orifice was found. The fiber delivered laser energy homogenously at 3600, causing shrinkage of the fistula tract around the fiber while it was withdrawn at the speed of 1 mm/s<br>Procedure: Internal orifice closure<br>* Closure of internal orifice with a purse-string suture using 2-0 polyglactin suture material.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from perianal fistula disease severity score at 6 months | 0: no active disease or complete healing, slight drainage with minimal symptoms, persistent symptomatic drainage, painful symptomatic drainage, severe perianal disease potentially requiring diversion | 6th month after the surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sphincter injury, anal abscess, incontinence