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Versius手术系统的临床前评估:一种用于微创前列腺手术的下一代手术机器人。

Preclinical evaluation of the Versius surgical system: A next-generation surgical robot for use in minimal access prostate surgery.

作者信息

Vasdev Nikhil, Charlesworth Philip, Slack Mark, Adshead Jim

机构信息

Hertfordshire and Bedfordshire Urological Cancer Centre Lister Hospital Stevenage UK.

School of Life and Medical Sciences University of Hertfordshire Hertfordshire UK.

出版信息

BJUI Compass. 2023 Mar 13;4(4):482-490. doi: 10.1002/bco2.233. eCollection 2023 Jul.

Abstract

OBJECTIVES

To evaluate the Versius surgical system for robot-assisted prostatectomy in a preclinical cadaveric model using varying system setups and collect surgeon feedback on the performance of the system and instruments, in line with IDEAL-D recommendations.

MATERIALS AND METHODS

Procedures were performed in cadaveric specimens by consultant urological surgeons to evaluate system performance in completing the surgical steps required for a prostatectomy. Procedures were conducted using either a 3-arm or 4-arm bedside unit (BSU) setup. Optimal port placements and BSU layouts were determined and surgeon feedback collected. Procedure success was defined as the satisfactory completion of all steps of the procedure, according to the operating surgeon.

RESULTS

All four prostatectomies were successfully completed; two were completed with a 3-arm BSU setup and two using a 4-arm BSU setup. Small adjustments were made to the port and BSU positioning, according to surgeon preference, in order to complete the surgical steps. The surgeons noted some instrument difficulties with the Monopolar Curved Scissor tip and the Needle Holders, which were subsequently refined between the first and second sessions of the study, in line with surgeon feedback. Three cystectomies were also successfully completed, demonstrating the capability of the system to perform additional urological procedures.

CONCLUSIONS

This study provides a preclinical assessment of a next-generation surgical robot for prostatectomies. All procedures were completed successfully, and port and BSU positions were validated, thus supporting the progression of the system to further clinical development according to the IDEAL-D framework.

摘要

目的

根据IDEAL-D建议,在临床前尸体模型中使用不同的系统设置评估Versius手术系统用于机器人辅助前列腺切除术的效果,并收集外科医生对该系统及器械性能的反馈。

材料与方法

泌尿外科顾问医师在尸体标本上进行手术,以评估系统在完成前列腺切除术所需手术步骤方面的性能。手术使用3臂或4臂床边单元(BSU)设置进行。确定了最佳端口放置和BSU布局,并收集了外科医生的反馈。根据主刀医生的定义,手术成功为手术所有步骤的满意完成。

结果

所有四例前列腺切除术均成功完成;两例使用3臂BSU设置完成,两例使用4臂BSU设置完成。根据外科医生的偏好,对端口和BSU的位置进行了微调,以完成手术步骤。外科医生指出单极弯剪尖端和持针器存在一些器械问题,随后根据外科医生的反馈在研究的第一阶段和第二阶段之间进行了改进。还成功完成了三例膀胱切除术,证明了该系统进行其他泌尿外科手术的能力。

结论

本研究对用于前列腺切除术的下一代手术机器人进行了临床前评估。所有手术均成功完成,端口和BSU位置得到验证,从而支持该系统根据IDEAL-D框架推进到进一步的临床开发。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/77e3/10268579/f2fd5ab94bdd/BCO2-4-482-g005.jpg

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