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根据IDEAL框架对新型多端口机器人泌尿外科手术平台的临床研究评估:文献系统综述

Evaluation of Clinical Research on Novel Multiport Robotic Platforms for Urological Surgery According to the IDEAL Framework: A Systematic Review of the Literature.

作者信息

Ficarra Vincenzo, Rossanese Marta, Giannarini Gianluca, Longo Nicola, Viganò Silvia, Russo Domenico, Sorce Gabriele, Simonato Alchiede, Bartoletti Riccardo, Crestani Alessandro, Di Trapani Ettore

机构信息

Department of Clinical and Experimental Medicine, Urologic Section, University of Messina, Messina, Italy.

Department of Oncology, Urologic Section, AOU G. Martino, Messina, Italy.

出版信息

Eur Urol Open Sci. 2024 Jul 18;67:7-25. doi: 10.1016/j.euros.2024.06.014. eCollection 2024 Sep.

DOI:10.1016/j.euros.2024.06.014
PMID:39100226
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11293526/
Abstract

BACKGROUND AND OBJECTIVE

Several novel multiport robotic systems have been developed and introduced in clinical practice after regulatory approval. The objective of this systematic review was to assess the evolution status of novel robotic platforms approved for clinical use in urological surgery according to the IDEAL framework.

METHODS

A systematic review was conducted using the Medline and Scopus databases according to the updated Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines (CRD42024503227). Comparative or noncomparative studies reporting on any urological procedures performed with novel robotic platforms (Hugo RAS; Versius, KangDuo, Senhance, REVO-I, Avatera, Hinotori, Dexter, or Toumai) were selected and included in the analysis.

KEY FINDINGS AND LIMITATIONS

Seventy-four eligible studies were included, of which 67 (90.5%) were noncomparative surgical series representing developmental or explorative studies according to the IDEAL criteria. Only one randomised controlled trial (comparing KangDuo vs da Vinci robot-assisted partial nephrectomy) was included. The trial showed comparable perioperative outcomes between the two robotic systems. Four studies assessed clinical outcomes for patients undergoing urological procedures using a REVO-I (1 study), Senhance (2 studies), or Hinotori (1 study) system in comparison to the same procedures performed using a da Vinci system. All studies revealed outcomes comparable to those with the da Vinci system. Limitations include the small sample size in all studies, and assessment of first-generation novel platforms versus the fourth-generation multiarm da Vinci system in most of the comparative studies.

CONCLUSIONS AND CLINICAL IMPLICATIONS

A few poor-quality studies have compared the use of novel robotic platforms to da Vinci systems in urological surgery and demonstrated comparable results. Most studies can be classified as developmental or explorative, representing the initial steps of clinical research. Large multicentre series are needed to understand whether these novel robots could offer advantages beyond cost reductions over the da Vinci systems.

PATIENT SUMMARY

We reviewed research on new robotic systems for surgery in urology. Several studies have shown the feasibility and safety of these new robots during the most common procedures. Very few studies have assessed clinical outcomes with the new robots in comparison to the reference standard, which is a fourth-generation da Vinci robot. Large multicentre studies are needed to understand whether the new robots could offer advantages other than cost savings over the da Vinci robot.

摘要

背景与目的

在获得监管批准后,几种新型多端口机器人系统已被开发并引入临床实践。本系统评价的目的是根据IDEAL框架评估已获批准用于泌尿外科手术临床的新型机器人平台的发展状况。

方法

根据更新后的系统评价和Meta分析优先报告项目(PRISMA)指南(CRD42024503227),使用Medline和Scopus数据库进行系统评价。纳入并分析了报告使用新型机器人平台(Hugo RAS、Versius、康多、Senhance、REVO-I、Avatera、日之鸟、Dexter或Toumai)进行的任何泌尿外科手术的比较性或非比较性研究。

主要发现与局限性

共纳入74项符合条件的研究,其中67项(90.5%)为非比较性手术系列研究,根据IDEAL标准属于发展性或探索性研究。仅纳入了一项随机对照试验(比较康多与达芬奇机器人辅助部分肾切除术)。该试验显示两种机器人系统的围手术期结果相当。四项研究评估了使用REVO-I系统(1项研究)、Senhance系统(2项研究)或日之鸟系统(1项研究)进行泌尿外科手术的患者的临床结果,并与使用达芬奇系统进行相同手术的结果进行了比较。所有研究均显示结果与达芬奇系统相当。局限性包括所有研究的样本量较小,且在大多数比较性研究中是将第一代新型平台与第四代多臂达芬奇系统进行评估。

结论与临床意义

少数质量较差的研究比较了新型机器人平台与达芬奇系统在泌尿外科手术中的应用,并显示结果相当。大多数研究可归类为发展性或探索性研究,代表了临床研究的初始阶段。需要大型多中心系列研究来了解这些新型机器人是否能提供除成本降低之外优于达芬奇系统的优势。

患者总结

我们回顾了泌尿外科手术新型机器人系统的研究。几项研究表明,这些新型机器人在最常见的手术过程中具有可行性和安全性。与作为参考标准的第四代达芬奇机器人相比,很少有研究评估新型机器人的临床结果。需要大型多中心研究来了解新型机器人是否能提供除成本节约之外优于达芬奇机器人的优势。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f306/11293526/97cc162bb716/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f306/11293526/97cc162bb716/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f306/11293526/97cc162bb716/gr1.jpg

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