AimAnal fistula is one of the most common anal diseases, affecting between 1 and 3 per 10 000 people per year. Symptoms have a potentially severe effect on a patient's quality of life. Surgery is the mainstay of treatment, aiming to cure the fistula and preserve anal sphincter function. Rectal advancement flap (RAF) is currently the gold standard treatment but has recurrence rates varying between 20% and 50% and might lead to disturbance of continence. The aim of the trial described in this work is to discover if the minimally invasive fistula tract laser closure (FiLaC™) technique could achieve higher healing rates and a better functional outcome than RAF.MethodWe will perform a randomized prospective multicentre noninferiority study of the treatment of high trans‐sphincteric perianal fistulas, comparing FiLaC™ with RAF in terms of fistula healing, recurrence rate, functional outcome and quality of life. Primary and secondary fistula healing will be evaluated at 26 and 52 weeks’ follow‐up. Quality of life will be evaluated using the SF‐36 questionnaire, the Faecal Incontinence Quality of Life Scale questionnaire and the Vaizey score at 3, 6, 12 and 26 weeks postoperatively.ConclusionHigh trans‐sphincteric fistulas have a potentially severe effect on a patient's quality of life. Classical treatment with RAF is a time‐consuming invasive procedure. The LATFIA trial aims to compare FiLaC™ with the gold standard treatment with RAF. In case of noninferiority, FiLaC™ treatment could be standardized as a first line treatment for high trans‐sphincteric fistulas. Better conservation of the patient's anal sphincter function could possibly be obtained. Likewise, we will report on the postoperative quality of life when applying these two techniques.

中文翻译：

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LATFIA 试验方案（肛门瘘管激光辅助治疗）：一项多中心、前瞻性、随机对照试验，比较瘘道激光闭合 (FiLaC™) 与直肠推进皮瓣治疗高位经括约肌瘘的情况

目的 肛瘘是最常见的肛门疾病之一，每年每 10 000 人中有 1 至 3 人患有肛瘘。症状对患者的生活质量有潜在的严重影响。手术是主要治疗方法，旨在治愈瘘管并保留肛门括约肌功能。直肠推进皮瓣 (RAF) 是目前的金标准治疗方法，但复发率在 20% 至 50% 之间变化，并可能导致失禁障碍。这项工作中描述的试验的目的是发现微创瘘管激光闭合 (FiLaC™) 技术是否可以实现比 RAF 更高的治愈率和更好的功能结果。方法我们将对治疗进行随机前瞻性多中心非劣效性研究高位经括约肌肛周瘘的治疗，比较 FiLaC™ 与 RAF 在瘘管愈合、复发率、功能结果和生活质量方面的情况。原发性和继发性瘘管愈合情况将在 26 周和 52 周的随访中进行评估。术后3、6、12和26周使用SF-36问卷、大便失禁生活质量量表问卷和Vaizey评分来评估生活质量。结论高位经括约肌瘘对患者的生活质量有潜在的严重影响的生活。 RAF 的经典治疗是一种耗时的侵入性手术。 LATFIA 试验旨在将 FiLaC™ 与 RAF 黄金标准治疗进行比较。如果非劣效性，FiLaC™治疗可以标准化为高位经括约肌瘘的一线治疗。可以更好地保护患者的肛门括约肌功能。同样，我们将报告应用这两种技术时的术后生活质量。