在宫腔镜手术中,精确膨宫液收集装置与传统装置相比的收集效率和安全性评估。
完整摘要 · 中文译文
目的:本研究旨在验证该装置在宫腔镜手术中收集膨宫液的有效性,为监测液体流出提供更可靠的工具。 方法:共164例计划接受择期宫腔镜手术的患者按1:1比例随机分配至精确收集组或对照组。精确收集组使用精确膨宫液收集装置进行宫腔镜膨宫液收集,对照组使用传统收集装置。主要结局为宫腔镜膨宫液收集率。次要结局包括不良事件发生率、手术室清洁时间,以及外科医生、护士和手术室辅助人员的满意度水平。 结果:两组患者基线特征或手术类型无显著差异。与传统液体收集装置相比,精确膨宫液收集装置显著提高了宫腔镜膨宫液收集率(95% vs. 48%,P < 0.001),并缩短了工作人员的手术室周转时间(4.1 min vs. 6.4 min,P < 0.001),同时还显著提高了手术团队满意度。 结论:精确膨宫液收集装置有效提高了宫腔镜膨宫液的收集率,降低了与液体管理不当相关的风险,缩短了手术室周转时间,并提高了手术团队的满意度。 临床试验注册: https://www.chictr.org.cn,标识号 ChiCTR2500101460。
完整摘要 · 英文原文
OBJECTIVE: This study aims to validate the effectiveness of this device in collecting distension fluid during hysteroscopic surgery, providing a more reliable tool for monitoring fluid outflow. METHODS: A total of 164 patients scheduled for elective hysteroscopy were randomly assigned in a 1:1 ratio to either the precision collection group or the control group. The precision collection group utilized a precision distension fluid collection device for hysteroscopic distension fluid collection, while the control group used a conventional collection device. The primary outcome was the hysteroscopic distension fluid collection rate. Secondary outcomes included the incidence of adverse events, operating room cleaning time, and satisfaction levels of surgeons, nurses, and operating room support staff. RESULTS: There were no significant differences in baseline patient characteristics or surgical types between the two groups. Compared to the conventional fluid collection device, the precision distension fluid collection device significantly improved the hysteroscopic distension fluid collection rate (95% vs. 48%, P < 0.001) and reduced the operating room turnover time for staff (4.1 min vs. 6.4 min, P < 0.001), while also substantially increasing surgical team satisfaction. CONCLUSION: The precision distension fluid collection device effectively enhances the collection rate of hysteroscopic distension fluid, reduces risks associated with improper fluid management, shortens operating room turnover time, and improves the satisfaction of the surgical team. CLINICAL TRIAL REGISTRATION: https://www.chictr.org.cn, identifier ChiCTR2500101460.