Laser Closure of Anal Fistula (FiLaC)

• ClinicalTrials.gov Identifier: NCT04161469
• Recruitment Status: Unknown
• First Posted: November 13, 2019
• Last Update Posted: November 13, 2019
• Sponsor: Surp Pırgiç Armenian Hospital
• Information provided by (Responsible Party): Kursat Serin, Surp Pırgiç Armenian Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Anal Fistula; Fistula in Ano; Sphincter Ani Incontinence	Procedure: Laser closure of the anal fistula tract (FiLaC); Procedure: Internal orifice closure	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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fiber delivered laser energy homogenously at 3600, causing shrinkage of the fistula tract around the fiber while it was withdrawn at the speed of 1 mm/s (2).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)
• Primary Purpose: Treatment
• Official Title: Laser Closure of Anal Fistula (FiLaC); Do we Need to Close Internal Orifice?
• Actual Study Start Date: August 1, 2019
• Estimated Primary Completion Date: October 1, 2020
• Estimated Study Completion Date: October 1, 2020

Arms and Interventions

Arm	Intervention/treatment
Group 1; Patients diagnosed with anal fistula treated by laser closure of the tract	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
Group 2; 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); 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.

Outcome Measures

Primary Outcome Measures :

1. Change from perianal fistula disease severity score at 6 months [ Time Frame: 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• superficial anal fistulas
• multibranching anal fistulas

Contacts and Locations

Contacts

Contact: Kursat Serin, Ass. Prof.; 00905322008163; dr_krserin@hotmail.com

Contact: Cem Terzi, Prof.; 00905323776935; mustafcem@gmail.com

Locations

Turkey

Surp Pırgic AH; Recruiting

Istanbul, Zeytinburnu, Turkey

Contact: Kursat R Serin, Ass. Prof. 00905322008163 dr_krserin@hotmail.com

Contact: Cem Terzi, Prof. 00905323776935 mustafcem@gmail.com

Sponsors and Collaborators

Surp Pırgiç Armenian Hospital

More Information

Publications of Results:

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.

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.

Ozturk E, Gulcu 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.

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.

• Responsible Party: Kursat Serin, Asistant Profesor, Surp Pırgiç Armenian Hospital
• ClinicalTrials.gov Identifier: NCT04161469
• Other Study ID Numbers: 2019-10
• First Posted: November 13, 2019
• Last Update Posted: November 13, 2019
• Last Verified: November 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR)

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kursat Serin, Surp Pırgiç Armenian Hospital:

sphincter injury; anal abscess; incontinence

Additional relevant MeSH terms:

Rectal Fistula; Fistula; Pathological Conditions, Anatomical; Intestinal Fistula; Digestive System Fistula; Digestive System Diseases; Intestinal Diseases; Gastrointestinal Diseases; Rectal Diseases