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Treatment of anal fistula with FiLaC®: results of a 10-year experience with 175 patients

Abstract

Background

Treatment of fistula-in-ano with fistula laser closure (FiLaC®) is a sphincter-saving procedure indicated for patients with complex anal fistulas. The aim of our study was to evaluate the clinical results of a 10-year experience with FiLaC®.

Methods

Data from patients with cryptoglandular anal fistula who underwent laser closure with FiLaC® in June 2009–May 2019 were evaluated.

The primary study endpoint was healing rate. Secondary endpoints were evaluation of morbidity and assessment of possible predictive factors of failure.

Results

Out of a total of 180 patients, 5 had been lost to follow-up. 175 patients [m:f: 115:60; median age 49 years (range18–81 years)] with cryptoglandular fistulas treated with FiLaC® were included in the study. Fistulas were transphincteric in 152 (86.8%) cases, intersphincteric in 18 (10.3%), and suprasphincteric in 5 (2.9%). A seton or draining silicon loop was placed in 142 (81.8%) patients at a median of 14 weeks (range10–28 weeks) prior to FiLaC®. At median follow-up of 60 months (range 9–120 months), the overall primary healing rate was 66.8% (117/175). Thirty-eight patients (21.7%) failed to heal. Twenty out of 175 (11.4%) patients had recurrence at median follow-up of 18 months (range 9–50 months). Patients in whom a seton/loop was inserted for drainage at the first-stage procedure had a statistically significant higher rate of success (100/142, 70.4% vs. 17/33, 51.5%, respectively; p 0.0377; odds ratio 0.45). Forty-eight patients were reoperated on at a median of 15 months (range 12–20 months) after laser treatment. Twenty-six underwent redo laser closure with FiLaC®, and 12 of them healed (46%), for a secondary success rate of 73.7%.

Conclusions

Longer follow-up confirms the efficacy of FiLaC® in the treatment of complex anal fistulas. Its use and implementation should be encouraged.

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Correspondence to P. Giamundo.

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Conflict of interest

Paolo Giamundo, first author, has been hired as “Surgical Trainer” for Biolitec Biomedical Technology in surgical “Live Surgery” sessions in Symposiums. However, he has no financial interests or employment honoraria with the company. Marsilio De Angelis, second author, has no disclosures.

Informed Consent

A period has been added in the Materials and Method section in which has been specified that all Patients signed and approved an informed consent.

Ethical Approval

In addition it has been cited that the trial has been conducted in accordance with the ethical standards reported in the declaration of Helsinki and that, as the procedure was part of the routine practice in the centers participating to the trial, the study was deemed exempt from the local IRB approval in the participating centers.

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Disclaimers: Paolo Giamundo is “surgical trainer” for Biolitec Italia but has no financial interests in the company; Marsilio De Angelis has nothing to disclose. There is no grant support or financial relationship between the current manuscript and any private or public company.

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Giamundo, P., De Angelis, M. Treatment of anal fistula with FiLaC®: results of a 10-year experience with 175 patients. Tech Coloproctol 25, 941–948 (2021). https://doi.org/10.1007/s10151-021-02461-4

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  • DOI: https://doi.org/10.1007/s10151-021-02461-4

Keywords

  • Anal fistula
  • Laser
  • FiLaC®
  • Fistula closure
  • Laser ablation