LATFIA-trial: Laser Assisted Treatment of Fistula In Ano Randomized Controlled Trial comparing FiLaC(TM) to Rectal Advancement Flap
Trial Overview
| Acronym | LATFIA |
|---|---|
| Number | NCT05390151 |
| Protocol Link | https://onlinelibrary.wiley.com/doi/10.1111/codi.16951 |
| Status | Open/recruiting |
| Category | Proctology |
| Treatment Course | Surgery |
Trial Description
| The LATFIA-trial investigates the efficacy of FiLaC(TM) versus RAF in managing anal fistulas. Anal fistula, affecting 1-3 per 10,000 people annually, severely impacts quality of life. Surgery is the mainstay of treatment, aiming to cure the fistula and preserve the anal sphincter function. Rectal advancement flap (RAF) is currently the gold standard treatment, but entails recurrence rates varying between 20 – 50% and might lead to continence disturbances. The Fistula Laser Closing (FiLaCTM) endo |
Chief Investigator
|
Niels Komen MD-PhD |
| Profile Link |
Lead Centre
|
Antwerp University Hospital Drie Eikenstraat 655 Edegem (Antwerp) 2650 Belgium |
| Website |
Collaboration and Funding
Collaborative Sites
| 1. Brussels University Hospital Laarbeeklaan 101 Jette (Brussels) 1090 Belgium Contact: Jasper Stijns Website |
| 2. Ghent University Hospital Corneel Heymanslaan 10 Ghent 9000 Belgium Contact: Dirk Van de Putte Website |
| 3. University Hospital Leuven Herestraat 49 Leuven 3000 Belgium Contact: Gabriele Bislenghi Website |
| 4. Jessa Hospital Standsomvaart 11 Hasselt 3500 Belgium Contact: Bert Houben Website |
| 5. Sint-Dimpna Hospital Geel J.-B. Stessensstraat 2 Geel 2440 Belgium Contact: Ben Gys Website |
| 6. Gasthuiszusters Antwerpen Oosterveldlaan 22 Antwerpen 2610 Belgium Contact: Els Van Dessel Website |
Funding Sponsors
| 1. Research Foundation - Flanders (FWO) FWO supports fundamental and strategic basic research · in Flanders · and international. |
Additional Information
Full Research Summary| Objective: | The objective of the LATFIA-trial is to comprehensively evaluate and compare the efficacy, safety, and patient-reported outcomes of the Fistula Laser Closure (FiLaCTM) technique versus Rectal Advancement Flap (RAF) in the treatment of trans-sphincteric perianal fistulas. |
| Aim: | The aim of the LATFIA (Laser vs. Advancement Flap in Anal Fistula) trial is to determine whether FiLaC(TM) offers superior outcomes in terms of fistula healing rates, recurrence rates, quality of life, and preservation of anal sphincter function compared to the current gold standard treatment, RAF. This study aims to provide robust evidence to inform clinical practice and improve patient outcomes in the management of anal fistulas. |
| Methods: | The LATFIA-trial is a multicenter, randomized study comparing the effectiveness of the Fistula Laser Closure (FiLaCTM) technique with Rectal Advancement Flap (RAF) in the treatment of transsphincteric perianal fistulas. The primary endpoint is fistula healing, which will be assessed at both 26 and 52 weeks postoperatively. Additionally, postoperative quality of life and continence will be evaluated using the SF-36, Fecal Incontinence Quality of Life Scale (FIQL), and Vaizey scores at 3, 6, 12, and 26 weeks. Inclusion criteria encompass patients with a single continuous fistula tract involving more than one-third of the anal sphincter or those deemed unsuitable for fistulotomy, with a loose seton present for at least two months. Exclusion criteria include fistula tracts smaller than 1 cm, complex fistula systems, individuals under the age of 18, pregnant patients, those with HIV-positive status, Crohn's disease, ulcerative colitis, malignancy-related fistulas, tuberculosis, hidradenitis suppurativa, pilonidal disease, absence of an internal opening, and contraindications to MRI. Based on a power of 80% and a significance level of 5%, the study aims to enroll 79 patients per arm to ensure adequate statistical power for detecting meaningful differences between the treatment groups. |
| Reason for International Trial: | Our current recruitment strategy may present challenges in achieving the desired sample size. While the number of institutions in Flanders is indeed limited, we understand the necessity of broadening our recruitment efforts to include a more diverse patient population and to enhance the generalizability of our findings. We are actively exploring the possibility of international recruitment. By collaborating with additional centers, we aim to increase patient enrollment and ensure a more representative sample. This approach will not only enhance the external validity of our study but also facilitate the attainment of our desired sample size, thereby strengthening the statistical power and reliability of our findings. |