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预期随机试验的单次使用vs可重复使用的囊镜为尿道支架切除
Brett A Johnson1, Jay D Raman2, Sara L Best3
1Department of Urology, The University of Texas Southwestern Medical Center, Dallas, Texas, USA.
Journal of endourology
|August 11, 2023
概括
单次使用的囊镜与可重复使用的囊镜在尿管支架切除方面取得了相似的成功,大大缩短了手术时间,消除了再处理问题. 这项创新提高了泌尿器科程序的患者安全和效率.
科学领域:
- 泌尿器科 泌尿器科 泌尿器科 泌尿器科
- 医疗器械 医疗器械
- 预防传染病 预防传染病
背景情况:
- 可重复使用的囊泡镜带来风险,包括交叉污染,化学物质暴露和维护成本.
- 单次使用的囊镜为减轻感染风险和减少化学剂暴露提供了潜在的解决方案.
研究的目的:
- 为了比较一次性使用囊泡镜的疗效和安全性与可重复使用的囊泡镜用于尿路支架的去除.
- 在随机试验中评估程序时间,不良事件和临床医生的满意度.
主要方法:
- 一个多中心的,随机的,双臂的市场后临床试验,涉及102名患者.
- 一次性囊镜 (Ambu A/S) 与标准护理的灵活可重复使用的囊镜的比较.
- 主要终点:成功切除支架;次要终点:手术时间,不良事件,临床医生的满意度.
主要成果:
- 可比较的成功切除支架率:可重复使用支架100% (51/51) 和一次性使用支架98% (50/51).
- 使用一次性囊泡镜 (10.2分钟) 与可重复使用 (18.4分钟) 从准备到处置/再加工节省了大量时间 (p < 0.001).
- 两组之间没有临床医生的满意度或不良事件的显著差异;可重复使用臂的一个严重不良事件.
结论:
- 单次使用的囊泡镜表现出与可重复使用的用于尿路支架切除的对应器相似的设备成功.
- 单次使用的囊镜可以大大节省时间,并提供相应的临床医生满意度,同时通过消除再处理来提高安全性.
- 这支持一次性囊镜作为一种可行的替代方案,以减少感染风险并提高泌尿器科程序的效率.
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