Long-term safety and efficacy of loose combined cutting seton therapy for high anal fistula: Evidence from a prospective cohort study

BACKGROUND: The healing rate after treatment in patients with high anal fistula (HAF) remains low. In individuals with HAF, the loose combined cutting seton (LCCS) technique has shown promising effectiveness, demonstrating a high cure rate, low incidence of incontinence and reduced pain levels. OBJECTIVES: To assess the long-term efficacy and safety of LCCS technique in patients with HAF. MATERIAL AND METHODS: The LCCS procedure was conducted in patients with HAF between December 2020 and February 2022. All participants were followed up for 12 months. The primary outcome was fistula healing, while secondary outcomes included fistula recurrence, visual analogue scale (VAS) pain score, severity of fecal incontinence, and quality of life. RESULTS: A total of 132 patients with HAF were included in the final analysis, with a mean follow-up duration of 17.0 ±3.8 months. At the 12-month follow-up, 130 patients (98.5%) achieved fistula healing. Among them, 103 patients who received primary HAF treatment at our center fully recovered, while 27 of 29 patients previously treated unsuccessfully at other hospitals achieved healing within 12 months, corresponding to a 93.1% success rate. Ninety patients (68.2%) reported no fecal incontinence at follow-up (Wexner Continence Grading Scale (WCGS) score = 0), and 42 patients had a WCGS score of 1. The LCCS procedure was associated with a persistently low risk of postoperative perianal discomfort, with 127 patients (96.2%) scoring 0 and only 5 (3.8%) scoring 1 on the VAS. CONCLUSIONS: The LCCS technique is a safe and effective treatment for patients with HAF.