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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。

Safety and efficacy of the MP1000 surgical system in robot-assisted radical cystectomy: A prospective study.

作者信息

Ai Qing, Zhao Xupeng, Jiang Bin, Cheng Qiang, Lu Yin, Tang Jinlu, Feng Yi, Tang Lu, Zhang Xu, Li Hongzhao

机构信息

Department of Urology, The Third Medical Centre of Chinese PLA General Hospital, Beijing 100039, China.

School of Medicine, Nankai University, Tianjin 300071, China.

出版信息

Bladder (San Franc). 2024 Nov 6;11(3):e21200013. doi: 10.14440/bladder.2024.0026. eCollection 2024.

Abstract

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.

摘要

背景

机器人辅助根治性膀胱切除术(RARC)因其诸多优势已被广泛采用,其中达芬奇机器人手术系统在全球最为常用。然而,高昂的成本限制了其更广泛的应用。

目的

本研究旨在评估使用更经济的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,将2024年4月至6月计划进行RARC的21例患者随机分配,分别接受达芬奇Si系统或MP1000系统的手术。主要结局是转为开放手术或腹腔镜手术的比例。次要结局包括机器人手臂安装时间、总手术时长、术中并发症、术中失血量、术后切缘阳性率、术后住院时间以及术后短期并发症。

结果

所有手术均成功完成,未转为开放或腹腔镜手术,未观察到与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系统的机器人手臂安装时间略长(20.75分钟对17.13分钟,P<0.001)。两组在手术时长、术中失血量、术后切缘阳性率、术后住院时间或术后短期并发症方面无统计学显著差异。此外,在衡量操作者工作量的美国国家航空航天局任务负荷指数评分方面也无显著差异。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RARC的一种安全、可行且有效的替代方案,其结果与达芬奇Si系统相当。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7545/11617064/cfacd1061ad6/bladder-11-e21200013-g001.jpg

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