EndoCAS, Center for Computer Assisted Surgery, University of Pisa, Pisa, Italy.
EndoCAS, Center for Computer Assisted Surgery, University of Pisa, Pisa, Italy; Information Engineering Department, University of Pisa, Pisa, Italy.
Eur Urol. 2016 Jun;69(6):1065-80. doi: 10.1016/j.eururo.2015.09.021. Epub 2015 Oct 1.
CONTEXT: No single large published randomized controlled trial (RCT) has confirmed the efficacy of virtual simulators in the acquisition of skills to the standard required for safe clinical robotic surgery. This remains the main obstacle for the adoption of these virtual simulators in surgical residency curricula. OBJECTIVE: To evaluate the level of evidence in published studies on the efficacy of training on virtual simulators for robotic surgery. EVIDENCE ACQUISITION: In April 2015 a literature search was conducted on PubMed, Web of Science, Scopus, Cochrane Library, the Clinical Trials Database (US) and the Meta Register of Controlled Trials. All publications were scrutinized for relevance to the review and for assessment of the levels of evidence provided using the classification developed by the Oxford Centre for Evidence-Based Medicine. EVIDENCE SYNTHESIS: The publications included in the review consisted of one RCT and 28 cohort studies on validity, and seven RCTs and two cohort studies on skills transfer from virtual simulators to robot-assisted surgery. Simulators were rated good for realism (face validity) and for usefulness as a training tool (content validity). However, the studies included used various simulation training methodologies, limiting the assessment of construct validity. The review confirms the absence of any consensus on which tasks and metrics are the most effective for the da Vinci Skills Simulator and dV-Trainer, the most widely investigated systems. Although there is consensus for the RoSS simulator, this is based on only two studies on construct validity involving four exercises. One study on initial evaluation of an augmented reality module for partial nephrectomy using the dV-Trainer reported high correlation (r=0.8) between in vivo porcine nephrectomy and a virtual renorrhaphy task according to the overall Global Evaluation Assessment of Robotic Surgery (GEARS) score. In one RCT on skills transfer, the experimental group outperformed the control group, with a significant difference in overall GEARS score (p=0.012) during performance of urethrovesical anastomosis on an inanimate model. Only one study included assessment of a surgical procedure on real patients: subjects trained on a virtual simulator outperformed the control group following traditional training. However, besides the small numbers, this study was not randomized. CONCLUSIONS: There is an urgent need for a large, well-designed, preferably multicenter RCT to study the efficacy of virtual simulation for acquisition competence in and safe execution of clinical robotic-assisted surgery. PATIENT SUMMARY: We reviewed the literature on virtual simulators for robot-assisted surgery. Validity studies used various simulation training methodologies. It is not clear which exercises and metrics are the most effective in distinguishing different levels of experience on the da Vinci robot. There is no reported evidence of skills transfer from simulation to clinical surgery on real patients.
背景:目前尚无单一的大型已发表随机对照试验(RCT)证实虚拟模拟器在获取安全的临床机器人手术技能方面的功效。这仍然是这些虚拟模拟器在外科住院医师课程中采用的主要障碍。
目的:评估发表的关于机器人手术虚拟模拟器培训效果的研究的证据水平。
证据获取:2015 年 4 月,对 PubMed、Web of Science、Scopus、Cochrane 图书馆、临床试验数据库(美国)和对照试验注册中心进行了文献检索。对所有出版物进行了相关性审查,并根据牛津循证医学中心制定的分类对提供的证据水平进行了评估。
证据综合:综述中包含的出版物包括一项 RCT 和 28 项关于有效性的队列研究,以及 7 项 RCT 和 2 项关于从虚拟模拟器到机器人辅助手术的技能转移的队列研究。模拟器被评为具有良好的逼真度(表面效度)和作为培训工具的有用性(内容效度)。然而,所纳入的研究使用了各种模拟培训方法,限制了对结构效度的评估。该综述证实,对于最广泛研究的达芬奇技能模拟器和 dV-Trainer,尚无任何共识认为哪些任务和指标最有效。尽管对 RoSS 模拟器有共识,但这仅基于涉及四项练习的两项关于结构效度的研究。一项关于使用 dV-Trainer 对部分肾切除术进行增强现实模块的初步评估的研究报告称,在猪体内进行肾切除术和虚拟肾吻合术的虚拟 Renorrhaphy 任务之间具有高度相关性(r=0.8),根据机器人手术的整体全球评估机器人手术(GEARS)评分。在一项关于技能转移的 RCT 中,实验组的表现优于对照组,在对无生命模型进行尿道膀胱吻合术时,总体 GEARS 评分(p=0.012)存在显著差异。只有一项研究评估了真实患者的手术:接受虚拟模拟器培训的受试者在传统培训后表现优于对照组。然而,除了数量较少外,这项研究没有进行随机分组。
结论:迫切需要一项大型、精心设计的、最好是多中心 RCT,以研究虚拟模拟在获得安全的临床机器人辅助手术技能方面的功效。
患者总结:我们回顾了机器人辅助手术的虚拟模拟器文献。验证研究使用了各种模拟培训方法。目前尚不清楚哪些练习和指标最能有效地区分达芬奇机器人上不同经验水平。没有关于从模拟到真实患者临床手术的技能转移的报告证据。
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