Abstract
Background
The aim of our study was to evaluate the efficacy of FiLaC® (Fistula Laser Closure) in the treatment of perianal fistulas in patients with Crohn’s disease.
Methods
All adult patients treated in our department between March 3rd 2016 and November 16th 2018 were included in the study. The fistula was considered healed when the internal and external openings were closed and the patient experienced no pain or leakage (spontaneously or under pressure).
Results
We included 20 consecutive patients (10 women) with a mean age of 32 years ± 9.61. The main fistula tracks were intersphincteric (n = 1, 5%), low (n = 3, 15%) or high (n = 14, 70%) transsphincteric, suprasphincteric (n = 1, 5%), or extrasphincteric (n = 1, 5%). Secondary extension (intramural, supralevator, or horseshoe) was found in 6 cases (30%). The average number of previous surgeries was 2.45 ± 1.47. Crohn’s disease extension was ileal in 2 patients (10%), ileocolonic in 8 patients (40%), and colonic in 10 patients (50%). Two patients were lost to follow up and were considered as failures. After a median follow-up period of 7.1 months (range 2–22.5 months), fistula healing was observed in 11 patients (55%). On univariate analysis, only the disease-modifying therapy for Crohn’s disease was a predictive factor of a response to FiLaC® (p = 0.05). The specific analysis of this subgroup showed that FiLaC® was less effective when patients were treated with anti-tumor necrosis factor (TNF) alone with an OR of 13.06 [1.28; 236.66] (p = 0.02). For combination therapy, the results seemed better (5 of 6 healed versus 2 of 9 healed with anti-TNF alone), but the difference was not significant.
Conclusions
This pilot study suggests that FiLaC® may play an important role in the management of perianal fistulas in patients with Crohn’s disease.
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References
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Acknowledgements
The authors thank Nesrine Ben Nasr and Helene Beaussier for their valuable assistance.
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MA and NL were invited to attend a demonstration of the surgical technique. NF and VdP received honoraria for speaking at symposia (AbbVie, Takeda, Tillots). VdP has a position on advisory board (Takeda). The other authors declare that they have no conflict of interest. They were directly involved in producing the manuscript and have not received any financial support and/or grant for the research or drafting of the manuscript.
Ethical approval
Data were collected during the usual patient treatment (excluding the Jardé law) and the study protocol was submitted and accepted by the hospital’s ethics committee.
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All the patients included in the study gave their consent to use their data for research analysis.
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Alam, A., Lin, F., Fathallah, N. et al. FiLaC® and Crohn’s disease perianal fistulas: a pilot study of 20 consecutive patients. Tech Coloproctol 24, 75–78 (2020). https://doi.org/10.1007/s10151-019-02134-3
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DOI: https://doi.org/10.1007/s10151-019-02134-3