Elshafei Moustafa
Department of General, Visceral, and Minimally Invasive Surgery, Krankenhaus Nordwest, Frankfurt, Germany.
J Laparoendosc Adv Surg Tech A. 2025 May;35(5):357-364. doi: 10.1089/lap.2024.0390. Epub 2025 Mar 28.
Standard-of-care gastroesophageal reflux disease (GERD) procedures are associated with adverse events (AEs) (i.e., dysphagia, gas-bloating). RefluxStop has been developed to circumvent these outcomes. This study presents the results of 28 patients managed with RefluxStop in Germany. Between July 2021 and November 2023, 28 patients with GERD underwent RefluxStop surgery, a novel laparoscopic antireflux procedure. Retrospective chart analysis with patient-informed consent was conducted to determine clinical outcomes, such as GERD Health-Related Quality of Life (GERD-HRQL) score, proton pump inhibitors (PPI) use, symptomatology, patient satisfaction, and perioperative AEs. Baseline characteristics ( = 28): age 47 ± 13.1 years; 67.9% female; body mass index (BMI) 27.3 ± 4.1 kg/m; 93% PPI use for 5.6 ± 2.7 years; and hiatal hernia in 100% of cases of mean (standard deviation [SD]) size 3.4 (0.8) cm, whereof 35.7% were large hiatal hernia (4-6 cm). At a mean (SD) follow-up of 14.1 (4.7) months, patients experienced 88.6% improvement in median (IQR) total GERD-HRQL score from a baseline of 35 (7.7) to 4 (4.2) at follow-up ( < .05). Preoperative dysphagia (35.7%) resolved completely in all patients ( < .001). The mean (SD) GERD-HRQL heartburn subdomain decreased by 90.6% from a baseline of 18.1 (6.1) to 1.7 (1.2) at follow-up and all patients (100%) had scores <5. Similarly, the mean (SD) regurgitation subdomain decreased from a baseline of 13.2 (4.7) to 2 (1.6) at follow-up and all patients (100%) had scores <5. Patient satisfaction was achieved in 96.4% of patients with no PPI use required in 93% of patients ( < .001); only one patient required PPIs for persistent GERD symptoms. No cases of reoperation or esophageal dilatation were performed. Minor intraoperative AEs occurred in seven patients (i.e., neck emphysema). RefluxStop provides excellent safety and effectiveness outcomes for GERD treatment. Dysphagia completely resolved (0%) with 88.6% improvement in median GERD-HRQL score and satisfaction achieved in 96.4% of patients. These promising results reproduced the outcomes noted in the RefluxStop CE trial in real-world settings.
标准治疗的胃食管反流病（GERD）手术与不良事件（AE）相关（即吞咽困难、胃胀）。RefluxStop的研发旨在避免这些结果。本研究展示了在德国接受RefluxStop治疗的28例患者的结果。2021年7月至2023年11月期间，28例GERD患者接受了RefluxStop手术，这是一种新型的腹腔镜抗反流手术。在获得患者知情同意后进行回顾性病历分析，以确定临床结果，如GERD健康相关生活质量（GERD-HRQL）评分、质子泵抑制剂（PPI）使用情况、症状、患者满意度和围手术期不良事件。基线特征（n = 28）：年龄47±13.1岁；67.9%为女性；体重指数（BMI）27.3±4.1kg/m²；93%使用PPI达5.6±2.7年；100%的病例存在食管裂孔疝，平均（标准差[SD]）大小为3.4（0.8）cm，其中35.7%为大食管裂孔疝（4 - 6cm）。在平均（SD）14.1（4.7）个月的随访中，患者的GERD-HRQL总评分中位数（IQR）从基线的35（7.7）改善至随访时的4（4.2），改善率为88.6%（P <.05）。术前吞咽困难患者（35.7%）全部完全缓解（P <.001）。GERD-HRQL烧心子域的平均（SD）评分从基线的18.1（6.1）降至随访时的1.7（1.2），下降了90.6%，所有患者（100%）评分<5。同样，反流子域的平均（SD）评分从基线的13.2（4.7）降至随访时的2（1.6），所有患者（100%）评分<5。96.4%的患者实现了患者满意度，93%的患者无需使用PPI（P <.001）；只有1例患者因持续性GERD症状需要使用PPI。未进行再次手术或食管扩张病例。7例患者发生轻微术中不良事件（即颈部气肿）。RefluxStop为GERD治疗提供了出色的安全性和有效性结果。吞咽困难完全缓解（0%），GERD-HRQL评分中位数改善88.6%，96.4%的患者实现了满意度。这些令人鼓舞的结果在现实世界环境中重现了RefluxStop CE试验中所记录的结果。
