Abstract
ObjectiveTo 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.Summary background dataRobot-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.MethodsCadaveric 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.ResultsNine 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.ConclusionsThis 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.
Highlights
The Versius Surgical System is a novel tele-operated robotic surgical system (Supplementary Fig. 1) designed to assist surgeons in performing Minimal access surgery (MAS) and overcome some of the challenges associated with currently available surgical robots [10, 11]
Tested port and bedside unit (BSU) positions for two of the most frequently performed procedures—cholecystectomy, and left hemicolectomy combined with low anterior resection (Table 2)—are discussed in more detail
A preclinical assessment of the system for transanal total mesorectal excision in a cadaveric model has previously been published [16]; the studies presented here demonstrate the ability of the system to perform many other general and colorectal procedures
Summary
The human cadaver studies were conducted at the Evelyn Cambridge Surgical Training Centre, UK, and at the AdventHealth Nicholson Centre, USA, between 24th July 2018 and 22nd August 2019. Procedures were performed by a lead surgeon supported by a surgical team. The lead surgeon performed the surgical steps for the procedure and evaluated the system in line with the objectives of the specific study. The two lead surgeons performing procedures in pigs were practising consultant surgeons who were GLP trained and certified and possessed UK Home Office licences. The lead surgeon determined the port and BSU positions, based on their established, standard technique of performing the same procedure, either by conventional laparoscopic means or robotically using another system. Positions were deemed suitable if good access to the surgical site(s) was achieved without arm clashing and there was minimal need to reposition the BSUs. Surgical access and reach for a subset of procedures were evaluated by the lead surgeon using a visual analogue scale (VAS). Recovery pigs were euthanised after 22–29 days and subject to a detailed necropsy, with specific reference to surgical sites and the assessment of successful organ removal and intact anastomosis
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