LASER FiLaC™ (FISTULA LASER CLOSURE) : First-line Treatment of Complex Anal Fistulas

January 20, 2022 updated by: Groupe Hospitalier Paris Saint Joseph

Complex anal fistula is a fistula whose treatment with fistulotomy would expose the patient to an excessive risk of post-operative continence disorders. It is a challenge in proctological surgery because of the complexity of its therapeutic management in relation to the recurrences' frequency and the need to preserve sphincter function. Indeed, management is mainly based on fistulotomy techniques, but the latter expose patients to a significant alteration of their continence (less than 10% incontinence for simple fistulas but 30-50% for complex fistulas). In addition, these fistulas' management is constraining for patients due to the need for multiple interventions, long-term post-operative care and repeated discontinuation of activity.

Sphincteral saving techniques have therefore developed over the last three decades and have enriched the therapeutic panel of complex fistulas. They aim to block fistula pathways without risking altering sphincter function. In addition, their surgical consequences are often simple. However, they are associated with a greater risk of failure than after fistulotomy and sometimes disappointing to the point that some of these techniques have been gradually abandoned (biological glue and plug for example).

Among these sphincteral saving techniques, the investigators know the advancement flap, the injection of biological glue, plug's installation, the LIFT (Ligation of Inter sphincteric Fistula Tract), the clip's use but also, more recently a laser treatment, FiLaC™ (for Fistula Laser Closure), knowing that the idea was not new since the ND-YAG3 and CO24.5 lasers were already used in the treatment of anal fistulas, about twenty years ago, in experimental studies.

This technique consists of radiating 360° laser energy radially into the fistula path to "burn" it and causing thermal destruction by coagulation of the fistula wall ans granulation tissue2. It can bo offered to any type of fistula at risk on continence, including horseshoe extensions that can be treated at the same time. It is well suited for outpatient management because the postoperative period is simple and painless.

The literature is still poor on the subject with some studies published openly but the preliminary results are encouraging with a success rate of about 70%. No continence disorders reported.

Study Overview

Status

Completed

Conditions

Detailed Description

A first retrospective study was conducted in the medical and surgical proctology department of the Hospital Group Paris Saint-Joseph on a cohort on 69 consecutive patients seen between May 2016 ans April 2017 and treated by FiLaC™ for a complex anal fistula. This technique has thus cured 60% of patients with superior trans-sphincter fistula. No incontinence-type complications were observed. These results, all the interesting as it was a learning phase, led the investigators to continue to use FiLaC™, which is currently practiced by all the team's practitioners as a first-line sphincter savings technique. The idea of this new work is to conduct an evaluation on a larger cohort of patients now that the investigators have more experience and it is being used routinely in the department at Groupe Hospitalier Paris Saint-Joseph.

Study Type

Observational

Enrollment (Actual)

110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Ile-de-France
      • Paris, Ile-de-France, France, 75014
        • Groupe hospitalier Paris saint Joseph

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient with complex anal fistula treated by the FiLaC™ between 05/01/17 and 05/01/18

Description

Inclusion Criteria:

  • Patient with complex anal fistula treated by the FiLaC™ between 05/01/17 and 05/01/18

Exclusion Criteria:

  • Patient scheduled for treatment by FiLaC™ and collected as such but finally treated by fistulotomy given a fistula pathway considered intraoperatively less complex than expected
  • Patient with recto vaginal or vaginal skin fistula
  • Patient under guardianship or curators
  • Patient deprived of liberty
  • Patient objecting to the use of their data for this research

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess on a larger scale the cure rate of patients treated by the proctology department between May 2017 and May 2018 for complex anal fistula.
Time Frame: 6 months
Clinical cure rate (in percentage) of complex anal fistula treated with FiLaC at the last medical contact in Groupe Hospitalier Paris Saint-Joseph.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identify predictive factors for clinical fistula healing to determine the best indications.
Time Frame: 6 months
This outcome corresponds to evaluate the correlations between patients' clinical characteristics and cure rates.
6 months
Confirm on a larger scale the absence of anal incontinence after treatment with FiLaC™ .
Time Frame: 1 year

Comparison of Wexner's scores before and after the intervention. This score evaluates the importance of anal incontinence, it varies from 0 to 20, 20 corresponding to total incontinence.

It is criticized for varying too much according to the transit.
1 year
Description of possible complications
Time Frame: 1 year
This outcome corresponds to the number of events per person of other complications after surgery
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier Paris Saint Joseph

Investigators

  • Principal Investigator: Vincent De PARADES, M.D, Groupe hospitalier Paris saint Joseph

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 7, 2019

Primary Completion (Actual)

June 2, 2019

Study Completion (Actual)

June 2, 2019

Study Registration Dates

First Submitted

August 1, 2019

First Submitted That Met QC Criteria

January 20, 2022

First Posted (Actual)

January 21, 2022

Study Record Updates

Last Update Posted (Actual)

January 21, 2022

Last Update Submitted That Met QC Criteria

January 20, 2022

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LASER FILAC 2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Complex Anal Fistula

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Myanmar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe