Laser Closure of Anal Fistula (FiLaC)

Surp Pırgiç Armenian Hospital

Status: Unknown

Conditions: Fistula in Ano; Sphincter Ani Incontinence; Anal Fistula

Treatments: Procedure: Laser closure of the anal fistula tract (FiLaC); Procedure: Internal orifice closure

Study type: Interventional

Funder types: Other

Identifiers

NCT04161469

2019-10

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• complex anal fistula
• high anal fistulas
• recurrent anal fistulas

Exclusion criteria

• superficial anal fistulas
• multibranching anal fistulas

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Group 1

Other group

Description:

Patients diagnosed with anal fistula treated by laser closure of the tract

Treatment:

Procedure: Laser closure of the anal fistula tract (FiLaC)

Group 2

Other group

Description:

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

Treatment:

Procedure: Internal orifice closure

Procedure: Laser closure of the anal fistula tract (FiLaC)