Effectiveness of Laser-Based Fistula Therapies with and without Adjunctive Measures in Anal Fistulas Management: A Systematic Review and Single-Arm Meta-Analysis.

PURPOSE: Fistula Laser Closure (FiLaC®) is a sphincter-preserving technique for anal fistulas, but its efficacy and safety remain under discussion. Therefore, we aim to evaluate the efficacy and safety of FiLaC® in the management of patients with cryptoglandular fistulas.

METHODS

A systematic review was performed in MEDLINE, Embase, and Cochrane databases in January 2025, following PRISMA guidelines. We included randomized controlled trials (RCTs) and observational studies assessing FiLaC® for cryptoglandular fistulas, with or without surgical adjunctive measures. The main outcome was the primary healing rate. Secondary outcomes included fistula recurrence, incontinence, reoperation rates, and postoperative complications. Subgroup analyses explored variables related to the primary healing rate. Data are presented as percentages (95% confidence interval). Statistical analyses were performed using R (version 4.4.1 (2024-06-14 (ucrt)).

RESULTS

We included 24 studies with 1,503 patients. The pooled primary healing rate was 57.46% (49.40-65.33). Recurrence occurred in 18.48% of patients (10.14-28.47), while new-onset incontinence was rare (0.57%; 0.00-2.15). The reoperation rate was 36.49% (28.95-44.36), and anal abscesses or infections affected 6.54% (1.93-13.09) of patients. Subgroup analysis showed no statistically significant differences in the primary healing rate based on fistula type, adjunctive measures, or sex. Sensitivity analysis confirmed the robustness of our findings.

CONCLUSIONS

FiLaC® seems to be a safe option with an intermediate healing rate in patients with cryptoglandular fistulas, although it is associated with a considerable recurrence rate. While its sphincter preservation advantage is evident, further RCTs standardizing the technique and adjunctive approaches are needed to optimize outcomes and refine its application in fistula management.