治疗 RefluxStop 装置的无效食道运动患者的多中心短期和安全性研究
1Department of Surgery, Division of General Surgery, Comprehensive Cancer Center, Upper-GI Unit, Medical University of Vienna, Spitalgasse 23, Waehringer Guertel 18-20, 1090, Vienna, Austria.
RefluxStop手术为患有GERD和IEM的患者提供了安全有效的解决方案,显著改善了生活质量并减少了PPI的依赖. 这种新的抗逆流体手术在持续的GERD症状方面显示出有希望的短期结果.
科学领域:
- 胃肠病学 胃肠病学
- 手术创新 在外科创新.
- 医疗器械 医疗器械
背景情况:
- 胃食道逆流性疾病 (GERD) 显著影响生活质量,高达30%的患者经历了保守治疗不足的缓解.
- 在GERD患者中,无效的食道运动 (IEM) 可以导致手术干预后复杂的症状和潜在的术后食障碍.
- 现有的抗反流手术可能无法充分解决GERD和IEM患者的缺食问题.
研究的目的:
- 评估 RefluxStop 的安全性和有效性,这是一种新型的抗逆流体外科设备,用于患有 PPI 耐火性 GERD 和 IEM 的患者.
- 评估 RefluxStop 植入物对患者生活质量,药物使用和症状缓解的影响.
- 记录和分析与RefluxStop程序相关的任何不良事件.
主要方法:
- 一项观察性双中心研究,涉及连续诊断为PPI耐火性GERD和IEM的患者,这些患者接受了RefluxStop植入.
- 数据收集包括临床检查,GERD与健康相关的生活质量 (GERD-HRQL) 问卷和对质子抑制剂 (PPI) 使用的评估.
- 评估短期的安全性和有效性,包括对不良事件和住院时间的监测.
主要成果:
- RefluxStop植入导致GERD-HRQL得分显著改善 (32.83至6.6,p < 0.001),PPI使用量减少了84% (p < 0.001).
- 90%的患者报告症状消失或改善,并在第一次随访时感到满意,住院时间中位数为3天.
- 记录了两个严重的不良事件:一个需要修改的设备滑动 (Clavien-Dindo评分3b) 和一个没有干预的设备迁移.
结论:
- 植入 RefluxStop 装置证明了在治疗 GERD 和 IEM 的短期安全性和有效性.
- 该程序显著提高了患者的生活质量,并减少了对耐火性GERD的PPI的依赖.
- 需要进一步的长期研究来证实RefluxStop的持续益处和安全性.
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