Harsányi László, Kincses Zsolt, Veselinović Milan, Zehetner Joerg, Altorjay Áron
Department of Surgery, Transplantation and Gastroenterology, Semmelweis University, Budapest, Hungary.
The Department of Surgery Kenezy Campus, Clinical Center of the University of Debrecen Teaching Hospital, Debrecen, Hungary.
Surg Endosc. 2025 Jul;39(7):4615-4627. doi: 10.1007/s00464-025-11818-x. Epub 2025 Jun 20.
Standard 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.
RefluxStop 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.
Forty-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).
RefluxStop 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.
胃食管反流病（GERD）的标准手术治疗可能会导致术后出现与食物通道相关的麻烦后遗症（即吞咽困难、吞咽痛、气胀综合征、无法嗳气/呕吐），严重影响生活质量。本文展示了RefluxStop手术的五年结果，该手术重建了抗反流屏障，但未环绕食物通道，减少了此类相关后遗症。
在一项前瞻性、单臂、多中心研究中对50名GERD患者进行了RefluxStop手术评估。本报告重点关注与食物通道相关的结果。其他基本结果（如24小时pH值、质子泵抑制剂（PPI）使用情况）在另一篇报告中呈现，并在此处简要提及临床相关性。
44名受试者完成了5年随访；3名参与者因新冠疫情失访（即2例死亡，1例因长期新冠卧床），3例提前终止。受新冠影响的病例采用3年和4年随访数据。手术恢复后2周与5年随访期间与食物通道相关的不良事件（AE）包括：1例（2.1%）吞咽困难（另1例术后2周轻度吞咽困难，视为正常恢复）；1例（2.1%）吞咽痛；0例（0%）无法嗳气/呕吐；42例气胀无/改善，仅2例恶化。这些结果与GERD - HRQL总分改善（即基线时中位数为29.5，5年时为3.0）、PPI使用情况（2.1%）以及24小时pH监测结果（即5年时平均酸暴露时间为1.57%）一致。
在整个5年研究中，RefluxStop手术在与食物通道相关的结果方面表现良好：97.9%的受试者无吞咽困难不良事件；97.9%无吞咽痛不良事件；其中在5年时：95.7%气胀无/改善，100%无无法嗳气/呕吐情况。从临床相关性来看，97.9%的受试者在5年时未服用PPI。这些结果为RefluxStop的整体治疗效果增添了清晰度，可能对优先考虑将术后后遗症降至最低的GERD患者显示出潜在优势。
