Fistula Laser Closure

NCT ID: NCT03297138

Last Updated: 2018-05-30

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

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-16

Study Completion Date

2017-12-31

Brief Summary

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The anal complex fistula constitutes a challenge in proctologic surgery because of the of its therapeutic care complexity due to the frequency of recurrences and the necessity to protect the sphincter function.

For several years,differents techniques were developed "said sphincter sparing techniques" to handle fistulas at risk on the anal continence.

Recently there is one of them , named FiLAC using a clip system not yet evaluated.

The purpose is to assess the success rate of his new surgery technique.

Detailed Description

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Conditions

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Fistula;Rectal

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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FiLAC laser

The technique consists in applying in a radial way to 360 ° an energy laser in the fistulous route. This energy allows a thermal destruction by coagulation of the wall of the fistula and the fabrics of granulations in a circular and regular way as well as a shrinkage of neighbouring fabrics. The repair is made by a call of macrophages and fibroblasts of neighbouring healthy fabrics so ending in a closure of the fistulous route

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patient with anal fistula drained at least 3 months before inclusion.

Exclusion Criteria

* Fistula not well drained
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondation Hôpital Saint-Joseph

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, France

Site Status

Countries

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France

Other Identifiers

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FILAC

Identifier Type: -

Identifier Source: org_study_id

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