Food passageway-related sequelae in the RefluxStop prospective multicenter trial: patient-centric outcomes of dysphagia, odynophagia, gas-bloating, and inability to belch and/or vomit at 5 years

Abstract

Introduction: Standard surgical management of GERD may result in troublesome postoperative food passageway-related sequelae (i.e., dysphagia, odynophagia, gas-bloat syndrome, inability to belch/vomit), significantly impacting quality of life. Five-year results after the RefluxStop procedure are presented, involving reconstruction of the anti-reflux barrier without encircling the food passageway, reducing such related sequelae. Methods: RefluxStop surgery was evaluated in a prospective, single-arm, multicenter study with 50 GERD subjects. This report focuses on food passageway-related outcomes. Other basic outcomes (e.g., 24-h pH, PPI usage) are presented in a separate report with brief clinical correlation herein. Results: Forty-four subjects completed 5-year follow-up; three participants were missing due to COVID-19 (i.e., two deaths and one bedbound with long-COVID) and three terminated early. Data from 3- and 4-year follow-up were carried forward in COVID-affected cases. Food passageway-related adverse events (AEs) between 2 weeks of surgical recovery and 5-year follow-up included: one case (2.1%) of dysphagia (and another case, mild dysphagia for 2 weeks postoperatively, viewed as normal recovery); one case (2.1%) of odynophagia; zero (0%) cases of inability to belch/vomit; and gas-bloating none/improved in 42 cases with only two worsening. These outcomes were well-aligned with improvement in total GERD-HRQL score (i.e., median 29.5 at baseline to 3.0 at 5 years), PPI usage (2.1%), and 24-h pH monitoring (i.e., mean 1.57% acid exposure time at 5 years). Conclusion: RefluxStop surgery resulted in a favorable profile of food passageway-related outcomes throughout the 5-year study: no AE dysphagia in 97.9% of subjects; no AE odynophagia in 97.9%; whereof at 5 years: gas-bloating none/improved in 95.7%, and no inability to belch/vomit in 100%. For clinical correlation, 97.9% of subjects did not take PPIs at 5 years. These outcomes add resolution to the overall treatment effect of RefluxStop and may show potential preference in GERD patients who prioritize minimization of postoperative sequelae.