Trial reportSurgical endoscopy2025
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.
Trial report in Surgical endoscopy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
6 citing papers in PubMed.
- Five-year clinical outcomes of RefluxStop surgery in the treatment of acid reflux: a prospective multicenter trial of safety and effectiveness.Surgical endoscopy · 2025Trial
- Conversion from failed antireflux surgery to RefluxStop: A multicenter feasibility, technical evaluation, safety, and effectiveness study with 30 consecutive cases.Langenbeck's archives of surgery · 2026Article
- Safety outcomes in 602 GERD patients treated by RefluxStop: a multi-center real-world study from 22 centers across six European countries.Scientific reports · 2026Article
- Cost-effectiveness of RefluxStop for gastroesophageal reflux disease: analysis from an Italian healthcare perspective.BMC gastroenterology · 2026Article
- Cost-Effectiveness of RefluxStop Versus Nissen Fundoplication and Proton Pump Inhibitors for Refractory Gastroesophageal Reflux Disease: A Spanish Healthcare Perspective.PharmacoEconomics - open · 2026Article
- Cost-effectiveness of RefluxStop compared to proton pump inhibitors and Nissen fundoplication for management of persistent gastroesophageal reflux disease in Norway.Cost effectiveness and resource allocation : C/E · 2025Article
Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionStandard 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.
methodsRefluxStop 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.
resultsForty-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).
conclusionRefluxStop 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.
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