Laser Closure of Anal Fistula (FiLaC)

Not Applicable

• Conditions: Fistula in Ano; Anal Fistula; Sphincter Ani Incontinence
• Interventions: Procedure: Laser closure of the anal fistula tract (FiLaC); Procedure: Internal orifice closure

• Registration Number: NCT04161469
• Lead Sponsor: Surp Pırgiç Armenian Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2019-08-01
• Study First Submitted: 2019-10-22
• Status Verified: 2019-11
• Study First Submitted QC: 2019-11-11
• Last Update Submitted: 2019-11-11
• Study First Posted: 2019-11-13
• Last Update Posted: 2019-11-13
• Primary Completion: 2020-10-01
• Study Completion: 2020-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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

Exclusion Criteria

• superficial anal fistulas
• multibranching anal fistulas

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Laser closure of the anal fistula tract (FiLaC)	Patients diagnosed with anal fistula treated by laser closure of the tract
Group 2	Internal orifice closure	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
Group 2	Laser closure of the anal fistula tract (FiLaC)	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

Primary Outcome Measures

Name	Time	Method
Change from perianal fistula disease severity score at 6 months	6th month after the surgery	0: no active disease or complete healing,; 1. slight drainage with minimal symptoms,; 2. persistent symptomatic drainage,; 3. painful symptomatic drainage,; 4. severe perianal disease potentially requiring diversion

Trial Locations

Locations (1)

Surp Pırgic AH; 🇹🇷 Istanbul, Zeytinburnu, Turkey