Laser Closure of Anal Fistula (FiLaC)

Anal Fistula Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04161469
• Other study ID #: 2019-10
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: October 1, 2020

Study information

• Verified date: November 2019
• Source: Surp Pirgiç Armenian Hospital
• Contact: Kursat Serin, Ass. Prof.
• Phone: 00905322008163
• Email: dr_krserin[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• complex anal fistula

• high anal fistulas

• recurrent anal fistulas

Exclusion Criteria:

• superficial anal fistulas

• multibranching anal fistulas

Related Conditions & MeSH terms

• Anal Fistula
• Fistula
• Fistula in Ano
• Rectal Fistula
• Sphincter Ani Incontinence

Intervention

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
• Internal orifice closure
Closure of internal orifice with a purse-string suture using 2-0 polyglactin suture material.

Locations

Country	Name	City	State
Turkey	Surp Pirgic AH	Istanbul	Zeytinburnu

Sponsors (1)

Lead Sponsor	Collaborator
Surp Pirgiç Armenian Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Oztürk E, Gülcü B. Laser ablation of fistula tract: a sphincter-preserving method for treating fistula-in-ano. Dis Colon Rectum. 2014 Mar;57(3):360-4. doi: 10.1097/DCR.0000000000000067. — View Citation

Terzi MC, Agalar C, Habip S, Canda AE, Arslan NC, Obuz F. Closing Perianal Fistulas Using a Laser: Long-Term Results in 103 Patients. Dis Colon Rectum. 2018 May;61(5):599-603. doi: 10.1097/DCR.0000000000001038. — View Citation

Wilhelm A, Fiebig A, Krawczak M. Five years of experience with the FiLaC™ laser for fistula-in-ano management: long-term follow-up from a single institution. Tech Coloproctol. 2017 Apr;21(4):269-276. doi: 10.1007/s10151-017-1599-7. Epub 2017 Mar 7. — View Citation

Wilhelm A. A new technique for sphincter-preserving anal fistula repair using a novel radial emitting laser probe. Tech Coloproctol. 2011 Dec;15(4):445-9. doi: 10.1007/s10151-011-0726-0. Epub 2011 Aug 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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