Preclinical Evaluation of the Versius Surgical System, a New Robot-assisted Surgical Device for Use in Minimal Access Renal and Prostate Surgery

被引:50
|
作者
Thomas, Benjamin C. [1 ,2 ]
Slack, Mark [3 ]
Hussain, Muddassar [4 ]
Barber, Neil [4 ]
Pradhan, Ashish [5 ]
Dinneen, Eoin [6 ]
Stewart, Grant D. [7 ,8 ]
机构
[1] Royal Melbourne Hosp, Dept Urol, Melbourne, Vic, Australia
[2] Australian Med Robot Acad, Melbourne, Vic, Australia
[3] CMR Surg, Cambridge, England
[4] Frimley Hlth NHS Fdn Trust, Frimley Renal Canc Ctr, Surrey, England
[5] Cambridge Univ Hosp NHS Fdn Trust, Addenbrookes Hosp, Dept Urogynaecol, Cambridge, England
[6] UCL, Div Surg & Intervent Sci, London, England
[7] Univ Cambridge, Dept Surg, Addenbrookes Hosp, Cambridge Biomed Campus, Cambridge, England
[8] Cambridge Univ Hosp NHS Fdn Trust, Addenbrookes Hosp, Dept Urol, Cambridge, England
来源
EUROPEAN UROLOGY FOCUS | 2021年 / 7卷 / 02期
关键词
Minimally invasive surgical procedure; Nephrectomy; Prostatectomy; Robotic surgical procedures; Surgical procedures; Urogenital procedures;
D O I
10.1016/j.euf.2020.01.011
中图分类号
R5 [内科学]; R69 [泌尿科学(泌尿生殖系疾病)];
学科分类号
1002 ; 100201 ;
摘要
Background: Minimal access surgery (MAS) is well-established in urological surgery. However, MAS is technically demanding and associated with a prolonged learning curve. Robot-assisted laparoscopy has made progress in overcoming these challenges. Objective: The aim of this study was to evaluate the feasibility of a new robot-assisted surgical system (the Versius Surgical System; CMR Surgical, Cambridge, UK) for renal and prostate procedures in a preclinical setting, at the IDEAL-D phase 0. Design, setting, and participants: Cadaveric sessions were conducted to evaluate the ability of the system to complete all surgical steps required for a radical nephrectomy, prostatectomy, and pelvic lymph node dissection. A live animal (porcine) model was also used to assess the surgical device in performing radical nephrectomy safely and effectively. Procedures were performed by experienced renal and prostate surgeons, supported by a full operating room team. Outcome measurements and statistical analysis: Surgical access and reach were evaluated by the lead surgeon using a visual analogue scale. The precise surgical steps conducted to make the assessment that the procedures could be completed fully were recorded, as well as instruments used (including manual laparoscopic instruments) and endoscope angle. Results and limitations: In total, all 24 procedures were completed successfully in cadavers by eight different lead surgeons. Positioning of the ports and bedside units reflected the lead surgeon's preferred laparoscopic set-up and enabled good surgical access and reach, as quantified by a median visual analogue score of >= 6.5. Radical nephrectomies performed in pigs were all completed successfully, with no device- or non-device-related intraoperative complications recorded. Testing in human cadavers and pig models balances the bias introduced by each model; however, it is impossible to completely replicate the experience and performance of the robot for surgery in live humans. Conclusions: This is the first preclinical assessment of the Versius Surgical System for renal and prostate procedures. The safety and effectiveness of the system have been demonstrated and warrant progressive assessment in a clinical setting utilising the IDEAL-D framework. Patient summary: In this report, we looked at the usability of a new robot-assisted surgical device for renal and prostate surgery by testing the system in cadavers and pigs. We found that a number of different surgeons and operating team personnel were able to use the system to successfully complete the procedures under evaluation. We conclude that the system is ready to be tested in live human studies. (C) 2020 European Association of Urology. Published by Elsevier B.V.
引用
收藏
页码:444 / 452
页数:9
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