A retrospective study assessing RefluxStop surgery for gastroesophageal reflux disease: Clinical outcomes in 79 patients from Germany.

IF 1.4 Q3 SURGERY Surgery open science Pub Date : 2024-12-18 eCollection Date: 2025-01-01 DOI:10.1016/j.sopen.2024.12.003

Thorsten Lehmann, Mantas Šimkus, Christoph Oehler

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Abstract

Background: This study reports outcomes of the RefluxStop procedure treating gastroesophageal reflux disease (GERD) in clinical practice at a high-volume regional hospital in Germany.

Methods: A retrospective analysis was conducted on 79 patients with chronic GERD that underwent the RefluxStop procedure, comprising high mediastinal dissection, loose cruroplasty, esophagogastroplication between vagal trunks, and fundus invagination of the RefluxStop implant. The primary outcome was GERD Health-Related Quality-of-Life (GERD-HRQL) score and improvement from baseline. Secondary outcomes included proton pump inhibitor (PPI) use and intra- and postoperative complications, including dysphagia, esophageal dilatation, and reoperation.

Results: Baseline characteristics (n = 79) included large hiatal hernia >3 cm (32.4 %) and previous antireflux surgery (20.3 %). At mean (SD) follow-up of 11 (4.4) months ranging from 4 to 19 months, the median (IQR) and mean (SD) improvements in GERD-HRQL score were 100 % (90.2-100 %) and 92.4 % (13.9 %) from baseline, respectively. Significant reduction in PPI use was observed from a baseline of 94.9 % to 2.5 % at follow-up. All cases of preoperative dysphagia (7.6 %) completely resolved. New-onset, mild dysphagia occurred in one subject (1.3 %) at final follow-up. One subject (1.3 %) experienced asymptomatic device migration into the stomach, likely due to surgical technique with a much too tight invagination, with subsequent conversion to Toupet fundoplication.

Conclusion: Analysis of this cohort that underwent RefluxStop surgery indicates excellent safety and effectiveness over this short-term follow-up. Significant improvements in quality of life and PPI use were observed in a population where half had either large hiatal hernia >3 cm or reoperation for previously failed antireflux surgery, a demographic with usually much higher complication rates.

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一项评估RefluxStop手术治疗胃食管反流病的回顾性研究：来自德国的79例患者的临床结果

背景：本研究报告了在德国一家大容量地区医院应用RefluxStop治疗胃食管反流病（GERD）的临床实践结果。方法：回顾性分析79例接受了reffluxstop手术的慢性胃食管反流病患者，包括高纵隔分离、松散胃成形术、迷走干之间的食管胃折叠和reffluxstop植入物的眼底内陷。主要终点是GERD健康相关生活质量（GERD- hrql）评分和较基线的改善。次要结果包括质子泵抑制剂（PPI）的使用和术中及术后并发症，包括吞咽困难、食管扩张和再手术。结果：基线特征（n = 79）包括大裂孔疝（3cm）（32.4%）和既往抗反流手术（20.3%）。平均（SD）随访11（4.4）个月，从4到19个月，与基线相比，GERD-HRQL评分的中位（IQR）和平均（SD）改善分别为100%（90.2- 100%）和92.4%（13.9%）。随访时观察到PPI的使用从基线的94.9%显著降低到2.5%。所有术前吞咽困难病例（7.6%）完全缓解。在最后的随访中，有一名受试者（1.3%）出现了新发的轻度吞咽困难。1名受试者（1.3%）无症状地将器械移至胃内，可能是由于手术技术过于紧致内陷，随后转换为Toupet底吻合。结论：对该队列进行了reffluxstop手术的分析表明，该短期随访具有良好的安全性和有效性。生活质量和PPI的使用均有显著改善，其中一半的患者患有大裂孔疝（30cm）或因先前失败的抗反流手术而再次手术，这一人群的并发症发生率通常更高。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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