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Fistula Laser Closure

NCT03297138 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2018-05-30

No results posted yet for this study

Summary

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.

Conditions

  • Fistula;Rectal

Interventions

PROCEDURE

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

Sponsors & Collaborators

  • Fondation Hôpital Saint-Joseph

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-16
Primary Completion
2016-12-31
Completion
2017-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03297138 on ClinicalTrials.gov