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Versius手术系统的临床前评估,这是一种用于微创普通外科和结直肠手术的新型机器人辅助手术设备。

Preclinical evaluation of the versius surgical system, a new robot-assisted surgical device for use in minimal access general and colorectal procedures.

作者信息

Morton Jonathan, Hardwick Richard H, Tilney Henry S, Gudgeon A Mark, Jah Asif, Stevens Lewis, Marecik Slawomir, Slack Mark

机构信息

Department of Gastrointestinal Surgery, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge, UK.

Department of Surgery, Frimley Health NHS Foundation Trust, Frimley Park Hospital, Surrey, UK.

出版信息

Surg Endosc. 2021 May;35(5):2169-2177. doi: 10.1007/s00464-020-07622-4. Epub 2020 May 13.

Abstract

OBJECTIVE

To evaluate the utility of a new robot-assisted surgical system (the Versius Surgical System, CMR Surgical, Cambridge, UK) for use in minimal access general and colorectal surgery, in a preclinical setting. Robot-assisted laparoscopy has been developed to overcome some of the important limitations of conventional laparoscopy. The new system is designed to assist surgeons in performing minimal access surgery and overcome some of the challenges associated with currently available surgical robots.

METHODS

Cadaveric sessions were conducted to evaluate the ability of the system to provide adequate surgical access and reach required to complete a range of general and colorectal procedures. Port and bedside unit positions were recorded, and surgical access and reach were evaluated by the lead surgeon using a visual analogue scale. A live animal (porcine) model was used to assess the surgical device's safety in performing cholecystectomy or small bowel enterotomy.

RESULTS

Nine types of procedure were performed in cadavers by nine lead surgeons; 35/38 procedures were completed successfully. The positioning of ports and bedside units reflected the lead surgeons' preferred laparoscopic set-up and enabled good surgical access and reach. Cholecystectomy (n = 6) and small bowel enterotomy (n = 5) procedures performed in pigs were all completed successfully by two surgeons. There were no device-related intra-operative complications.

CONCLUSIONS

This preclinical study of a new robot-assisted surgical system for minimal access general and colorectal surgery demonstrated the safety and effectiveness of the system in cadaver and porcine models. Further studies are required to assess its clinical utility.

摘要

目的

在临床前环境中评估一种新型机器人辅助手术系统(Versius手术系统,CMR Surgical,英国剑桥)用于微创普通外科和结直肠手术的效用。机器人辅助腹腔镜手术的开发是为了克服传统腹腔镜手术的一些重要局限性。新系统旨在协助外科医生进行微创手术,并克服与当前可用手术机器人相关的一些挑战。

方法

进行尸体实验以评估该系统提供足够手术入路和完成一系列普通和结直肠手术所需操作范围的能力。记录端口和床边单元的位置,由主刀医生使用视觉模拟量表评估手术入路和操作范围。使用活体动物(猪)模型评估手术器械在进行胆囊切除术或小肠切开术时的安全性。

结果

9位主刀医生在尸体上进行了9种类型的手术;38例手术中有35例成功完成。端口和床边单元的定位反映了主刀医生偏好的腹腔镜设置,并实现了良好的手术入路和操作范围。两位外科医生在猪身上进行的胆囊切除术(n = 6)和小肠切开术(n = 5)均成功完成。没有与器械相关的术中并发症。

结论

这项针对用于微创普通外科和结直肠手术的新型机器人辅助手术系统的临床前研究证明了该系统在尸体和猪模型中的安全性和有效性。需要进一步研究以评估其临床效用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cd33/8057987/d20a43a59a13/464_2020_7622_Fig1_HTML.jpg

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