NCT04161469

Laser Closure of Anal Fistula (FiLaC)

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Surp Pırgiç Armenian Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anal Fistula
• Fistula in Ano
• Sphincter Ani Incontinence

Interventions

Type	Name	Description
PROCEDURE	Laser closure of the anal fistula tract (FiLaC)	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fiber delivered laser energy homogenously at 3600, causing shrinkage of the fistula tract around the fiber while it was withdrawn at the speed of 1 mm/s
PROCEDURE	Internal orifice closure	Closure of internal orifice with a purse-string suture using 2-0 polyglactin suture material.

Timeline

• Start date: 2019-08-01
• Primary completion: 2020-10-01
• Completion: 2020-10-01
• First posted: 2019-11-13
• Last updated: 2019-11-13

Locations

1 site across 1 country: Turkey (Türkiye)