MP1000手术系统在机器人辅助根治性膀胱切除术中的安全性和有效性:一项前瞻性研究。

Bladder (San Francisco, Calif.) Pub Date : 2024-11-06 eCollection Date: 2024-01-01 DOI:10.14440/bladder.2024.0026
Qing Ai, Xupeng Zhao, Bin Jiang, Qiang Cheng, Yin Lu, Jinlu Tang, Yi Feng, Lu Tang, Xu Zhang, Hongzhao Li
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引用次数: 0

摘要

背景:机器人辅助根治性膀胱切除术(RARC)因其众多优点而被广泛采用,达芬奇机器人手术系统是全球最常用的手术系统。然而,高成本限制了其广泛应用。目的:本研究旨在评价使用更经济的MP1000手术系统进行RARC的安全性和有效性。方法:在这项前瞻性、单中心、单盲研究中,21名计划于2024年4月至6月进行RARC的患者被随机分配接受达芬奇Si系统或MP1000系统的手术。主要结果是转开或腹腔镜手术的比率。次要结局包括机械臂安装时间、手术总时间、术中并发症、术中出血量、术后阳性切缘率、术后住院时间和术后短期并发症。结果:所有手术均顺利完成,未转开或腹腔镜手术,无机器人机械故障相关的术中并发症。与达芬奇Si系统相比,MP1000系统的机械臂安装时间略长(20.75 min vs. 17.13 min, P < 0.001)。两组在手术时间、术中出血量、术后阳性切缘率、术后住院时间、术后短期并发症等方面差异无统计学意义。此外,美国国家航空航天局任务负荷指数得分也没有显著差异,该指数是衡量操作员工作量的指标。本研究的主要局限性是样本量小。结论:该研究表明MP1000手术系统是一种安全、可行、有效的RARC替代方案,并取得了与达芬奇Si系统相当的结果。
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Safety and efficacy of the MP1000 surgical system in robot-assisted radical cystectomy: A prospective study.

Background: Robot-assisted radical cystectomy (RARC) has become widely adopted due to its numerous advantages, with the da Vinci robotic surgical system being the most commonly used across the globe. However, the high cost limits its broader application.

Objective: This study aimed to evaluate the safety and efficacy of performing RARC using the more economical MP1000 surgical system.

Methods: In this prospective, single-center, single-blind study, 21 patients scheduled for RARC between April and June 2024 were randomly assigned to undergo surgery with either the da Vinci Si system or the MP1000 system. The primary outcome was the rate of conversion to open or laparoscopic surgery. Secondary outcomes included robotic arm installation time, total surgery duration, intraoperative complications, intraoperative blood loss, post-operative positive margin rate, length of post-operative hospital stay, and short-term post-operative complications.

Results: All surgeries were successfully completed without conversion to open or laparoscopic procedures, and no intraoperative complications related to robotic mechanical failure were observed. The robotic arm installation time was slightly longer with the MP1000 system compared to the da Vinci Si system (20.75 vs. 17.13 min, P < 0.001). There were no statistically significant differences between the two groups in surgery duration, intraoperative blood loss, post-operative positive margin rate, post-operative hospital stay, or short-term post-operative complications. In addition, there was no significant difference in National Aeronautics and Space Administration Task Load Index scores, a measure of the operator workload. The primary limitation of this study was its small sample size.

Conclusion: The study demonstrated that the MP1000 surgical system was a safe, feasible, and effective alternative for RARC, and achieved comparable outcomes to the da Vinci Si system.

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