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Safety outcomes in 602 GERD patients treated by RefluxStop: a multi-center real-world study from 22 centers across six European countries
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DOI：10.1038/s41598-026-47034-3.png)
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Abstract
En 中文
RefluxStop surgery aims to restore a functional anti-reflux barrier in gastroesophageal reflux disease (GERD) without encircling the esophagus, purportedly limiting dysphagia and gas-bloating. This report presents safety outcomes from 602 patients at 22 centers across six European countries and up to 6.75 years follow-up (mean [SD] 2 [1.25] years). Serious safety outcomes and reoperation occurred in 1.99% (12/602), all satisfactorily resolved. Thereof, two-thirds were reherniations (1.33%), which manifested from total disruption of crural repair, resolved by straightforward fundic repositioning and redo hiatal repair with RefluxStop unaffected in its pouch. Non-operative safety events included 4/602 (0.66%) cases of asymptomatic erosion (without action) in the early postoperative phase (4 weeks) as the learning curve of a new procedure. Dilatation for new-onset dysphagia was performed in one patient. This report presents an analysis focused on safety data from the largest independent RefluxStop study to date (n = 602). Despite inter-surgeon variability, the learning curve for a new procedure, and sizable proportions of large hernia and/or dysmotility patients, results show low rates of serious safety outcomes with reoperations occurring in <2%. The overall experience of the RefluxStop Evaluation Group demonstrated a consistent and favorable mid-to-long-term safety profile for RefluxStop in real-world surgical treatment of GERD.
Keywords:
Diseases
Gastroenterology
Health care
Medical research
Science
Humanities and Social Sciences
multidisciplinary
Journal
IF:
3.9
Papers:
27.1W
Citations:
83.5W
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