Laser Closure of Anal Fistula (FiLaC)

NCT ID: NCT04161469

Last Updated: 2019-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2020-10-01

Brief Summary

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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

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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

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Anal Fistula Fistula in Ano Sphincter Ani Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1

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

Group Type OTHER

Laser closure of the anal fistula tract (FiLaC)

Intervention Type 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 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

Group Type OTHER

Laser closure of the anal fistula tract (FiLaC)

Intervention Type 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

Internal orifice closure

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Internal orifice closure

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* complex anal fistula
* high anal fistulas
* recurrent anal fistulas

Exclusion Criteria

* superficial anal fistulas
* multibranching anal fistulas
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Surp Pırgiç Armenian Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kursat Serin

Asistant Profesor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Surp Pırgic AH

Istanbul, Zeytinburnu, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Kursat Serin, Ass. Prof.

Role: CONTACT

00905322008163

Cem Terzi, Prof.

Role: CONTACT

00905323776935

Facility Contacts

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Kursat R Serin, Ass. Prof.

Role: primary

00905322008163

Cem Terzi, Prof.

Role: backup

00905323776935

References

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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.

Reference Type RESULT
PMID: 29528908 (View on PubMed)

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.

Reference Type RESULT
PMID: 21845480 (View on PubMed)

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.

Reference Type RESULT
PMID: 24509460 (View on PubMed)

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.

Reference Type RESULT
PMID: 28271331 (View on PubMed)

Other Identifiers

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2019-10

Identifier Type: -

Identifier Source: org_study_id

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