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Purpose <p>Gastroesophageal reflux disease (GERD) is a&#xa0;prevalent chronic condition. While proton pump inhibitors (PPIs) and Nissen fundoplication are mainstays, limitations include dysphagia and suboptimal outcomes in large hiatal hernias (HH) or ineffective esophageal motility (IEM). RefluxStop is a&#xa0;novel noncircumferential implant designed to restore anatomy without compression. This review synthesizes evidence on its efficacy, safety, and economics.</p> Methods <p>Per PRISMA 2020 guidelines, we systematically searched multiple databases up to March 2026 for studies on RefluxStop outcomes. Two investigators independently selected studies, extracted data, and assessed quality using MINORS.</p> Results <p>Fourteen studies (over 500 patients) with follow-up to 5&#xa0;years were included. RefluxStop significantly improved Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) scores (median improvement 79.9%–100%) and reduced PPI use from &gt; 90% to ≤ 7%. Safety was notable for low new-onset dysphagia (~2.9%) and rare device complications (~1.26%). It was particularly effective for large HH (≥ 4 cm) and IEM. European economic evaluations found it cost-effective compared to lifelong PPIs and fundoplication.</p> Conclusion <p>RefluxStop is an effective, safe, and cost-effective surgical option with a&#xa0;favorable dysphagia profile, addressing needs in specific phenotypes like large HH or IEM. Primarily observational evidence exists; ongoing randomized trials and long-term data are awaited to confirm its durability and comparative role in the GERD treatment algorithm.</p>

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RefluxStop surgery for gastroesophageal reflux disease: a systematic review of efficacy, safety, and health economic evidence

  • 期刊论文

  • 发表日期：

    2026年7月1日

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  • Zhaoqi Shi,
  • Xiaoxiao Fan,
  • Xiaolong Liu,
  • Qilong Chen,
  • Diyu Huang

摘要

Purpose

Gastroesophageal reflux disease (GERD) is a prevalent chronic condition. While proton pump inhibitors (PPIs) and Nissen fundoplication are mainstays, limitations include dysphagia and suboptimal outcomes in large hiatal hernias (HH) or ineffective esophageal motility (IEM). RefluxStop is a novel noncircumferential implant designed to restore anatomy without compression. This review synthesizes evidence on its efficacy, safety, and economics.

Methods

Per PRISMA 2020 guidelines, we systematically searched multiple databases up to March 2026 for studies on RefluxStop outcomes. Two investigators independently selected studies, extracted data, and assessed quality using MINORS.

Results

Fourteen studies (over 500 patients) with follow-up to 5 years were included. RefluxStop significantly improved Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) scores (median improvement 79.9%–100%) and reduced PPI use from > 90% to ≤ 7%. Safety was notable for low new-onset dysphagia (~2.9%) and rare device complications (~1.26%). It was particularly effective for large HH (≥ 4 cm) and IEM. European economic evaluations found it cost-effective compared to lifelong PPIs and fundoplication.

Conclusion

RefluxStop is an effective, safe, and cost-effective surgical option with a favorable dysphagia profile, addressing needs in specific phenotypes like large HH or IEM. Primarily observational evidence exists; ongoing randomized trials and long-term data are awaited to confirm its durability and comparative role in the GERD treatment algorithm.