Department of Abdominal Surgery, Antwerp University Hospital, Edegem, Belgium.
Antwerp ReSURG, Antwerp Surgical Training, Anatomy and Research Centre (ASTARC), Faculty of Medicine and Health Sciences, University of Antwerp, Wilrijk, Belgium.
Colorectal Dis. 2024 May;26(5):1038-1046. doi: 10.1111/codi.16951. Epub 2024 Mar 18.
Anal 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.
We 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.
High 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.
肛瘘是最常见的肛门疾病之一，每年每 10000 人中就有 1 至 3 人患病。该疾病的症状可能会严重影响患者的生活质量。手术是该病的主要治疗方法，旨在治愈瘘管并保留肛门括约肌功能。直肠前突皮瓣（RAF）目前是金标准治疗方法，但复发率在 20%至 50%之间，并且可能会导致控便功能障碍。本研究中描述的试验旨在发现微创瘘管激光闭合（FiLaC）技术是否能比 RAF 达到更高的愈合率和更好的功能结果。
我们将对高经括约肌型肛周肛瘘进行一项随机前瞻性多中心非劣效性研究，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差异。主要和次要瘘管愈合将在 26 周和 52 周随访时进行评估。使用 SF-36 问卷、粪便失禁生活质量量表问卷和 Vaizey 评分在术后 3、6、12 和 26 周评估生活质量。
高经括约肌型肛瘘可能会严重影响患者的生活质量。RAF 是经典的治疗方法，但它是一种耗时的侵入性手术。LATFIA 试验旨在比较 FiLaC 与 RAF 的金标准治疗。如果非劣效性成立，FiLaC 治疗可作为高经括约肌型肛瘘的一线治疗方法。可能会更好地保留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。
