Laser Closure of Anal Fistula (FiLaC)

NCT04161469 | Unknown

• 1 other identifier: 2019-10
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Anal Fistula; Fistula in Ano; Sphincter Ani Incontinence

Keywords

sphincter injury; anal abscess; incontinence

Outcome Measures

Primary Outcomes (1)

• Change from perianal fistula disease severity score at 6 months

  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

  6th month after the surgery

Study Arms (2)

Group 1

OTHER

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

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

Group 2

OTHER

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); Procedure: Internal orifice closure

Interventions

Laser closure of the anal fistula tract (FiLaC) PROCEDURE

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fiber delivered laser energy homogenously at 3600, causing shrinkage of the fistula tract around the fiber while it was withdrawn at the speed of 1 mm/s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 1; Group 2

Internal orifice closure PROCEDURE

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

Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• superficial anal fistulas
• multibranching anal fistulas

Sponsors & Collaborators

• Surp Pırgiç Armenian Hospital: lead

Study Sites (1)

Surp Pırgic AH

Istanbul, Zeytinburnu, Turkey (Türkiye)

RECRUITING

Related Publications (4)

• 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.

  PMID: 29528908 RESULT

• 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.

  PMID: 21845480 RESULT

• 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.

  PMID: 24509460 RESULT

• 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.

  PMID: 28271331 RESULT

MeSH Terms

Conditions

Rectal Fistula

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Kursat Serin, Ass. Prof.

CONTACT

00905322008163; dr_krserin@hotmail.com

Cem Terzi, Prof.

CONTACT

00905323776935; mustafcem@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asistant Profesor

Model Details: 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).

Study Record Dates

• First Submitted: October 22, 2019
• First Posted: November 13, 2019
• Study Start: August 1, 2019
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: November 13, 2019

Record last verified: 2019-11

Locations

TU (1)