Surgical Laparoscopy Endoscopy & Percutaneous Techniques· 2026Q2
Dysphagia, Safety, and Effectiveness of the RefluxStop Procedure in GERD Patients With Ineffective Esophageal Motility (IEM)
- 1citations
- Q2SCImago
- 2026year
Short summary
The RefluxStop procedure, a novel GERD treatment that doesn't encircle the esophagus, effectively improved GERD-HRQL scores by a median of 89% and resolved or improved dysphagia in 86% of Ineffective Esophageal Motility (IEM) patients within one year.
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Key points
- RefluxStop procedure improved GERD-HRQL scores by a median of 89% (p<0.001) in 60 IEM-GERD patients.
- 92% of patients achieved >50% improvement in GERD-HRQL score at last follow-up.
- Dysphagia resolved or improved in 86% of IEM patients within 1 year (12/14 subjects with baseline dysphagia).
- The procedure demonstrated safety with no serious procedure- or device-related adverse events reported.
AI-generated from the title and abstract; the full text is not read.
Abstract
Background: Patients with gastroesophageal reflux disease (GERD) and ineffective esophageal motility (IEM) do not have optimal outcomes today. With standard-of-care antireflux procedures, dysphagia often worsens. RefluxStop treats acid reflux via a novel mechanism without encircling the esophagus. This study assesses dysphagia, safety, and efficacy of the RefluxStop procedure in subjects with IEM for up to 3 years.Methods: Clinical outcomes of RefluxStop in two IEM-GERD cohorts were evaluated retrospectively, in a combined investigator-initiated study at University Inselspital and Hirslanden Clinic Beau-Site in Switzerland. The primary outcome was incidence of dysphagia. The secondary outcomes included improvement in GERD Health-Related Quality of Life (GERD-HRQL), food passageway-related events, and serious procedure- or device-related adverse events (i.e., SAEs, SADEs).Results: Sixty (n=60) subjects with IEM underwent the RefluxStop procedure, with a follow-up ranging between 3-47 months (mean 13 months). Median (Q25-Q75) improvement in GERD-HRQL score was 89% (83-96%) with statistical significance (p<0.001; Wilcoxon test). At last follow-up, 92% of the subjects experienced >50% improvement in GERD-HRQL score. Of the 40 subjects that reached 1-year follow-up, n=14/40 (35%) had dysphagia at baseline, which resolved or improved in 12 subjects and worsened in one. Thus, there is a significant higher likelihood of dysphagia improvement compared to unchanged or worsened status (p=0.013).Conclusions: RefluxStop surgical management for GERD effectively treats subjects with IEM (n=60), who currently have no optimal treatment, while maintaining excellent results for up to 3 years with excellent improvement of GERD-HRQL score (median 89%) and dysphagia (86% resolved or improved at 1 year).
The authors' abstract, as published at the source. Surgical Laparoscopy Endoscopy & Percutaneous Techniques, 2026 · DOI ↗
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Field: Gastroenterology
GastroenterologyMedicine