A safety and effectiveness evaluation of refluxstop in the treatment of acid reflux comparing large and small hiatal hernia groups: results from 99 patients in Switzerland with up to 4-years follow-up.

Abstract

<h4>Background</h4>Standard-of-care surgical treatments for gastroesophageal reflux disease (GERD), with large hiatal hernia (HH), result in a reoperation rate of up to 50% at 5 years. RefluxStop, acting as a mechanical stop without encircling the food passageway, offers a novel approach to treat large HH patients. This study assesses the safety and efficacy of RefluxStop surgery comparing large and small HH groups followed for up to 4 years.<h4>Methods</h4>Two cohorts were retrospectively analyzed in a combined investigator-initiated study evaluating safety outcomes of RefluxStop in severe GERD subjects, comparing concomitant small (≤3 cm) and large HH (4-10 cm) in Switzerland. Primary outcomes were procedure-related adverse events (AEs/ADEs). The secondary outcome was improvement in GERD-HRQL score.<h4>Results</h4>Ninety-nine subjects underwent the RefluxStop surgical procedure, whereof 50 subjects had small (≤3 cm) and 49 subjects had large HH (4-10 cm). One surgeon at each site operated on both small and large hernia patients. No significant difference in AEs between patients with small and large HH was shown. At 1-year follow-up, subjects in both groups experienced statistically significant improvements in median (IQR) GERD-HRQL score of 93.8% (81.8%; 98.7%) for those with large HH and 85.7% (76.5%; 92.3%) for those with small HH.<h4>Conclusion</h4>RefluxStop surgery for GERD effectively treats patients with large HH that currently have no optimal treatment options, while showing significantly improved results for up to 4 years. Furthermore, RefluxStop provides equally favorable results and a robust low risk profile for subjects with either concomitant small (n = 49) and large (n = 50) HH.