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.

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.

European Society of Coloproctology: Guidelines for diagnosis and treatment of cryptoglandular anal fistula.

AIM: The primary aim of the European Society of Coloproctology (ESCP) Guideline Development Group (GDG) was to produce high-quality, evidence-based guidelines for the management of cryptoglandular anal fistula with input from a multidisciplinary group and using transparent, reproducible methodology. METHODS: Previously published methodology in guideline development by the ESCP has been replicated in this project. The guideline development process followed the requirements of the AGREE-S tool kit. Six phases can be identified in the methodology. Phase one sets the scope of the guideline, which addresses the diagnostic and therapeutic management of perianal abscess and cryptoglandular anal fistula in adult patients presenting to secondary care. The target population for this guideline are healthcare practitioners in secondary care and patients interested in understanding the clinical evidence available for various surgical interventions for anal fistula. Phase two involved formulation of the GDG. The GDG consisted of 21 coloproctologists, three research fellows, a radiologist and a methodologist. Stakeholders were chosen for their clinical and academic involvement in the management of anal fistula as well as being representative of the geographical variation among the ESCP membership. Five patients were recruited from patient groups to review the draft guideline. These patients attended two virtual meetings to discuss the evidence and suggest amendments. In phase three, patient/population, intervention, comparison and outcomes questions were formulated by the GDG. The GDG ratified 250 questions and chose 45 for inclusion in the guideline. In phase four, critical and important outcomes were confirmed for inclusion. Important outcomes were pain and wound healing. Critical outcomes were fistula healing, fistula recurrence and incontinence. These outcomes formed part of the inclusion criteria for the literature search. In phase five, a literature search was performed of MEDLINE (Ovid), PubMed, Embase (Ovid) and the Cochrane Database of Systematic Reviews by eight teams of the GDG. Data were extracted and submitted for review by the GDG in a draft guideline. The most recent systematic reviews were prioritized for inclusion. Studies published since the most recent systematic review were included in our analysis by conducting a new meta-analysis using Review manager. In phase six, recommendations were formulated, using grading of recommendations, assessment, development, and evaluations, in three virtual meetings of the GDG. RESULTS: In seven sections covering the diagnostic and therapeutic management of perianal abscess and cryptoglandular anal fistula, there are 42 recommendations. CONCLUSION: This is an up-to-date international guideline on the management of cryptoglandular anal fistula using methodology prescribed by the AGREE enterprise.

Distalization of perianal fistulas after loose silicone seton drainage is a myth.

BACKGROUND: It is often stated that loose seton drainage results in distal migration of a fistula tract in perianal fistula. The aim of the present study was to assess this distalization of trans- and suprasphincteric perianal fistulas after a silicone seton has been inserted. METHODS: Consecutive patients who underwent loose seton placement for the management of a transsphincteric or suprasphincteric fistula between January 2016 and December 2021 with a pre- and postoperative magnetic resonance imaging (MRI) were included in the present retrospective study. The height of the external anal sphincter (EAS) and the level of penetration of perianal fistula through the EAS or puborectal muscle (PRM) were determined on MRI. Primary outcome was migration of the fistula tract through the EAS and PRM. RESULTS: Thirty-eight patients with perianal fistulas were included. Median height of the EAS was 28 (IQR 25-34) mm before seton placement and 27 (IQR 24-33) mm afterward. Median level of perforation was 32 (IQR 17-40) mm before seton placement and 28 (IQR 17-40) mm afterward (p = 0.37). One fistula (3%) was downgraded from mid to low transsphincteric and was laid open after 14.9 months of loose seton drainage. CONCLUSIONS: No statistically significant distalization of complex fistula tracts after loose silicone seton drainage was found. Some complex fistulas may downgrade to a less complex fistula after long-term seton drainage. However, loose silicone seton drainage should not be offered to patients as a treatment option to downgrade a complex fistula to a simple one or even have the hope to heal it.

Transanal Minimally Invasive Proctectomy With Two-Stage Turnbull-Cutait Pull-Through Coloanal Anastomosis for Iatrogenic Rectourethral Fistulas.

INTRODUCTION: Rectourethral fistula is an uncommon pathology, usually iatrogenic, occurring as a complication of surgical or ablative treatments for prostate or rectal cancer. Among other surgical techniques, restorative ultralow rectal anterior resection may be an option of last resort to achieve fistula closure avoiding the need for a permanent stoma. This article aims to describe a transanal minimally invasive-assisted Turnbull-Cutait technique for radiated rectourethral fistulas with a complementary video. TECHNIQUE: Turnbull-Cutait pull-through with delayed coloanal anastomosis technique with a proctectomy by transanal minimally invasive surgery and loop ileostomy was performed in 3 patients who developed delayed rectourethral fistula after prostate cancer treatment. Ileostomy was reversed after fistula closure confirmation. RESULTS: The first patient had brachytherapy with no surgery. The second patient had radical prostatectomy and adjuvant radiotherapy, developing the fistula after a pelvic abscess drained transrectally. The third patient underwent prostatectomy and brachytherapy, developing the fistula after transanal endoscopic microsurgery resection of a rectal villous polyp. Surgical intervention and postoperative recovery was uneventful. Fistula closure was confirmed in the 3 cases, and all ileostomies were closed without further recurrence at follow-up. CONCLUSIONS: Transanal minimally invasive proctectomy-assisted Turnbull-Cutait procedure for the treatment of rectourethral fistula is a new combination of already existing techniques, enabling the creation of safe colorectal anastomosis in high-risk cases. Given the difficulty obtaining healing with sphincter preservation in cases of postradiation rectourethral fistula, this technique aids in fistula closure and restoration of the intestinal continuity, and potentially represents an added resource in the surgical armamentarium for this challenging pathology.

Ligation of the Intersphincteric Fistula Tract for High Transsphincteric Fistula Yields Moderate Results at Best: Is the Tide Turning?

BACKGROUND: Ligation of the intersphincteric fistula tract is a well-accepted and often used surgical procedure for perianal fistulas. OBJECTIVE: This study aims to confirm results of the ligation of the intersphincteric fistula tract in a specialized colorectal center. DESIGN: This is a retrospective cohort study. SETTING: This study took place in a large colorectal surgical department with a tertiary referral center for perianal fistulas. PATIENTS: Consecutive patients were operated on with ligation of the intersphincteric fistula tract for a transsphincteric perianal fistula between 2012 and December 2018. INTERVENTIONS: Patients underwent ligation of the intersphincteric fistula tract. MAIN OUTCOME MEASURES: The primary outcome measured was the healing rate. The secondary outcomes measured were conversion into an intersphincteric perianal fistula, risk of recurrence, complications, and postoperative continence status. RESULTS: Forty-six patients were treated with a ligation of intersphincteric fistula tract procedure. All patients (100%) had preoperative imaging in their workup. Forty patients (87%) had a high transsphincteric fistula. The primary healing rate was a disappointing 17 of 46 patients (37%). The median time until failure was 4.2 months (interquartile range, 3.5-6.5). Of the failures, 16 converted to an intersphincteric fistula (55% of failures and 35% of all patients). The mean duration of follow-up in patients without a recurrence was 9.5 months (SD 11.9). Four patients (9%) were lost to follow-up. The mean Fecal Incontinence Severity Index postoperatively was only 2.35 (SD 5.7; range, 0-30). This resulted in 9 patients (20%) having a newly impaired continence status postoperatively. Continence impairment was mild in all these patients. The risk of developing a recurrence 1 year after surgery is 64.2% (95% CI, 49%-80%). LIMITATIONS: This study was limited by its retrospective design and the small numbers with possible selection bias. CONCLUSIONS: Results with the ligation of intersphincteric fistula tract procedure were not as good as hoped. The effect on fecal continence, however, was minimal. The procedure might be more suitable for low transsphincteric fistulas. See Video Abstract at http://links.lww.com/DCR/A992. LA LIGADURA DEL TRACTO DE LA FÍSTULA INTERESFINTÉRICA PARA UNA FÍSTULA TRANSESFINTÉRICA ALTA, PRODUCE RESULTADOS MODERADOS EN EL MEJOR DE LOS CASOS: ¿ESTÁ CAMBIANDO LA MAREA?: La ligadura del tracto de la fístula interesfintérica es un procedimiento quirúrgico bien aceptado y de uso frecuente para las fístulas perianales. OBJETIVO: Confirmar los resultados de la ligadura del tracto de la fístula interesfintérica en un centro colorrectal especializado. DISEÑO:: Estudio de cohorte retrospectivo. AJUSTE: Gran departamento de cirugía colorrectal y con centro de referencia terciaria para fístulas perianales. PACIENTES: Pacientes consecutivos operados con ligadura del tracto de la fístula interesfintérica para una fístula perianal transesfintérica, entre 2012 y diciembre de 2018. INTERVENCIONES: Ligadura del tracto de fístula interesfintérica. PRINCIPALES MEDIDAS DE RESULTADO: Tasa de cicatrización, resultados secundarios: conversión a una fístula perianal interesfintérica, riesgo de recurrencia, complicaciones y estado de continencia postoperatoria. RESULTADOS: Cuarenta y seis pacientes fueron tratados con una ligadura del tracto de la fístula interesfintérica. Todos los pacientes (100 por ciento) tenían imagenología en su preparación preoperatoria. Cuarenta pacientes (87 por ciento) tenían una fístula transesfintérica alta. La tasa de cicatrización primaria fue decepcionante en 17 de 46 pacientes (37 por ciento). El tiempo medio hasta el fracaso fue de 4.2 meses (rango intercuartil 3.5-6.5). De los fracasos, 16 se convirtieron en una fístula interesfintérica (55 por ciento de los fracasos y 35 por ciento de todos los pacientes). La duración media del seguimiento en pacientes sin recurrencia fue de 9.5 meses (desviación estándar de 11.9). Se perdieron durante el seguimiento a cuatro pacientes (9 por ciento). Después de la operación, el promedio del índice de severidad de incontinencia fecal fue de solo 2.35 (desviación estándar de 5.7, rango 0-30). Esto resultó en que 9 pacientes (20 por ciento) tuvieran una continencia deteriorada postoperatoria. El deterioro de la continencia fue leve en todos estos pacientes. El riesgo de desarrollar una recurrencia a un año después de la cirugía es del 64.2 por ciento (intervalo de confianza del 95 por ciento: 49-80 por ciento). LIMITACIONES: Diseño retrospectivo, números pequeños con posible sesgo de selección. CONCLUSIONES: Los resultados del procedimiento con la ligadura del tracto de fístula interesfintérica no fueron tan buenos como se esperaba. El efecto sobre la continencia fecal, sin embargo, fue mínimo. El procedimiento podría ser más adecuado para las fístulas transesfintéricas bajas. Vea el Resumen del video en http://links.lww.com/DCR/A992.