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Laser Closure of Anal Fistula (FiLaC)

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

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

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.




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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04161469


Contacts
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Contact: Kursat Serin, Ass. Prof. 00905322008163 dr_krserin@hotmail.com
Contact: Cem Terzi, Prof. 00905323776935 mustafcem@gmail.com

Locations
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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
Publications of Results:
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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    Key Record Dates
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)

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