CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 110 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT05201209
NCT05201209N/ACompleted

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

Fondation Hôpital Saint-Joseph·observational·Posted Jan 21, 2022·Updated Jan 21, 2022

In Brief

An observational study for Complex Anal Fistula. Completed, enrolled 110 participants across 1 site.

Detailed Summary

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 Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesFrance
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJan 21, 2022
Enrollment StartFeb 7, 2019
Primary CompletionJun 2, 2019
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 4.4 years ago