Department of Visceral Surgery, Hirslanden Klinik Beau-Site, Bern, Switzerland.
Department of Gastroenterology, Hirslanden Klinik Beau-Site, Bern, Switzerland.
Swiss Med Wkly. 2024 Jul 15;154:3365. doi: 10.57187/s.3365.
Anti-reflux surgery aims to restore the anti-reflux barrier and reduce the retrograde flow of stomach contents. However, traditional surgical techniques generally involve some degree of encircling of the oesophagus, which can result in adverse effects such as dysphagia and the inability to belch or vomit. Based on the first published results, a novel surgical technique - with the RefluxStop™ device - appears promising for treating gastroesophageal reflux disease (GERD) with minimal postoperative dysphagia. This study describes the initial clinical experience with this procedure in a cohort of patients with chronic gastroesophageal reflux disease to evaluate its feasibility and safety in clinical practice.
This retrospective cohort study examined the first 40 patients who underwent laparoscopic anti-reflux surgery with the RefluxStop™ device at a private hospital in Switzerland. The procedure involves implanting a nonactive device on the outside of the gastric fundus to stabilise a narrow oesophagogastric plication. Feasibility was assessed based on the proportion of patients in whom the device could be successfully implanted, with a discussion of the operative details. Intraoperative and postoperative complications, adverse effects, and changes in gastroesophageal reflux disease-related quality of life (GERD-HRQL questionnaire) are also reported.
Between May 2020 and April 2022, 40 patients underwent elective surgery for laparoscopic hiatal hernia repair and RefluxStop™ device implantation. All patients had typical symptoms of gastroesophageal reflux disease, such as heartburn and regurgitation; 20 (50%) had preoperative dysphagia. Laparoscopic surgery was feasible in all patients except one who required laparotomy due to adhesions and associated bleeding when accessing the abdomen. The median operating time was 57.5 minutes (interquartile range = 51.75-64.25 minutes) with no device-related intraoperative or postoperative complications. All patients were imaged one day and three months postoperative, confirming the correct placement of the device. Reflux symptoms (heartburn and acid regurgitation) were significantly improved in all patients at three months (p <0.0001).
These preliminary results support the feasibility and safety of introducing this novel laparoscopic anti-reflux surgical treatment option in clinical practice.
抗反流手术旨在恢复抗反流屏障并减少胃内容物的逆行流动。然而，传统的手术技术通常涉及一定程度的食管环绕，这可能导致吞咽困难、无法打嗝或呕吐等不良反应。基于首次发表的结果，一种新型手术技术 - RefluxStopTM 装置 - 似乎有望治疗胃食管反流病（GERD），且术后吞咽困难程度最小。本研究描述了该手术在瑞士一家私人医院的 40 例慢性胃食管反流病患者中的初步临床经验，以评估其在临床实践中的可行性和安全性。
这是一项回顾性队列研究，共纳入了在瑞士一家私人医院接受腹腔镜抗反流手术和 RefluxStopTM 装置植入的 40 例患者。该手术包括在胃底外部植入一个非活性装置，以稳定狭窄的食管胃折叠。根据能够成功植入装置的患者比例评估可行性，并讨论手术细节。还报告了术中及术后并发症、不良反应以及胃食管反流病相关生活质量（GERD-HRQL 问卷）的变化。
2020 年 5 月至 2022 年 4 月期间，有 40 例患者因腹腔镜食管裂孔疝修补术和 RefluxStopTM 装置植入术而接受了择期手术。所有患者均有典型的胃食管反流病症状，如烧心和反流；20 例（50%）患者术前有吞咽困难。除了 1 例患者因进入腹部时粘连和相关出血而需要剖腹手术外，所有患者均可行腹腔镜手术。中位手术时间为 57.5 分钟（四分位间距=51.75-64.25 分钟），无与器械相关的术中或术后并发症。所有患者术后第 1 天和第 3 个月均行影像学检查，证实了器械的正确位置。所有患者在术后 3 个月时反流症状（烧心和胃酸反流）均显著改善（p<0.0001）。
这些初步结果支持在临床实践中引入这种新型腹腔镜抗反流手术治疗选择的可行性和安全性。
