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<p>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 (<i>n</i> = 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 &lt;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.</p>

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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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年4月18日

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  • Sebastian F. Schoppmann,
  • Joerg Zehetner,
  • Moustafa Elshafei,
  • Thorsten Lehmann,
  • Ahmed Ahmed,
  • Naim Fakih-Gomez,
  • Joy Feka,
  • Fergus Noble,
  • Nicholas Boyle,
  • Maria Eugenia Barrios Carvajal,
  • Alberto Hernández Matias,
  • J. Daniel Sánchez López,
  • Marta Cuadrado Ayuso,
  • Beatriz Guil Ortiz,
  • Carlos Miliani Molina,
  • Carlos Moreno Sanz,
  • Gabriele Pozzo,
  • Maurizio Pavanello,
  • Adolfo Renzi,
  • Davide Bona,
  • Leonardo Vincenti,
  • Luigi Bonavina,
  • Yves Borbely,
  • John C. Lipham

摘要

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.