Background: Most patients with perianal fistulizing Crohn's disease (pfCD) present with complex types of perianal fistulas and need repetitive repair operations, resulting in a high risk of sphincter injury. Fistula-tract Laser Closure (FiLaC™) is a novel sphincter-saving technique that obliterates the fistula tract with a photothermal effect. The aim of the present systematic review and meta-analysis was to evaluate the efficacy and safety of FiLaC in pfCD.
Methods: This study was conducted according to Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines. Electronic databases, including PubMed, Embase, Cochrane Library and Wanfang Data were searched for published articles from January 2000 to June 2021. The clinicaltrials.gov website was searched for completed or ongoing trials on pfCD and FiLaC™. The references of each article were also searched for eligible data. The main outcome was the primary healing rate of the FiLaC™ procedure. Additionally, fecal incontinence was analyzed as the secondary outcome to evaluate the safety of FiLaC™.
Results: Six studies met the eligibility criteria and were included in the final analysis. All studies were published within the past 6 years and came from European countries. There were 50 pfCD patients recruited, and 31 patients' fistulas were healed after FiLaC™. The pooled primary healing rate was 68% (95% CI 53.0-84.0%, I2 = 27%, p = 0.23). There was no major fecal incontinence after surgery.
Conclusions: These data suggest that FiLaC™ may be an effective and safe procedure for pfCD patients. However, the evidence is poor and there is a need for more high-quality prospective controlled studies with long-term follow-up before this minimally invasive technique is recommended for surgical treatment of pfCD.
Keywords: Fecal incontinence; FiLaC™; Healing rate; Meta-analysis; Perianal fistulizing Crohn’s disease.
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