학술논문
Protocol of the LATFIA trial (Laser Assisted Treatment of Fistula in Ano): a multicentre, prospective, randomized controlled trial comparing fistula-tract laser closure (FiLaC™) with rectal advancement flap for high trans-sphincteric fistulas.
Document Type
Academic Journal
Author
Gaillard M; 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.; Van den Broeck S; 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.; Op de Beeck B; Department of Radiology, Antwerp University Hospital, Edegem, Belgium.; Wouters K; Clinical Trial Center, Antwerp University Hospital, Edegem, Belgium.; Stijns J; Department of Abdominal Surgery, University Hospital Brussels, Jette, Belgium.; Van de Putte D; Department of Abdominal Surgery, University Hospital Ghent, Ghent, Belgium.; Gys B; Department of Abdominal Surgery, Hospital St. Dimpna, Geel, Belgium.; Houben B; Department of Abdominal Surgery, Jessa Hospital, Hasselt, Belgium.; Van Dessel E; Department of Abdominal Surgery, GasthuisZusters Hospital, Antwerp, Belgium.; Bislenghi G; Department of Abdominal Surgery, University Hospital Leuven, Leuven, Belgium.; Komen N; 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.
Source
Publisher: Blackwell Science Ltd Country of Publication: England NLM ID: 100883611 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1463-1318 (Electronic) Linking ISSN: 14628910 NLM ISO Abbreviation: Colorectal Dis Subsets: MEDLINE
Subject
Language
English
Abstract
Aim: 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.
Method: 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.
Conclusion: 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.
(© 2024 Association of Coloproctology of Great Britain and Ireland.)
Method: 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.
Conclusion: 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.
(© 2024 Association of Coloproctology of Great Britain and Ireland.)