Preclinical evaluation of a new robot-assisted surgical system for use in gynecology minimal access surgery

Abstract

Robot-assisted laparoscopy has been developed to overcome some of the important limitations of conventional laparoscopy. In particular, the provision of stable magnified three-dimensional vision, tremor filtering, motion scaling, and articulated instruments with robot-assisted surgery has the potential to enable more surgeons to perform more complex surgery compared with conventional laparoscopy. The aim of this study was to evaluate the utility of a new robot-assisted surgical system (Versius, CMR Surgical, Cambridge, UK) for gynecologic procedures in a preclinical setting. Cadaveric sessions were conducted to evaluate the ability of the system to complete all surgical steps required for a robot-assisted total laparoscopy hysterectomy. A live animal (porcine) model was used to assess the system in performing oviduct removal as a surrogate for robot-assisted total laparoscopy hysterectomy. Procedures were performed by experienced gynecologic surgeons, supported by a surgical team. The precise surgical steps conducted to conclude that the procedures could be fully completed were systematically recorded, as well as instruments used and endoscope angle. In total, six gynecologic procedures were performed in cadavers by four surgeons; 16/17 procedures were completed successfully. Positioning of the ports and bedside units reflected the surgeons' preferred laparoscopic setup and enabled good surgical access and reach, as exemplified by the high procedure completion rate. Oviduct removal procedures performed in pigs were all completed successfully by a single surgeon. This preclinical study of a new robot-assisted surgical system for gynecologic procedures demonstrated the safety and effectiveness of the system in cadaver and porcine models. Further studies are required to assess its clinical utility.

Interim safety analysis of the first-in-human clinical trial of the Versius surgical system, a new robot-assisted device for use in minimal access surgery

“…This study shows promising first-in-human clinical trial data that support previous preclinical study results [18][19][20]. All 30 cases presented in this analysis were completed successfully and provide evidence supporting continued recruitment into the trial and inclusion of major surgical procedures.…”

“…The goal of the initial preclinical and Idea stages (Stage 0 and 1) is proof of concept-this was demonstrated through usability studies and procedure-specific assessment in cadavers and porcine models. [15,16,[18][19][20]. These studies provided an opportunity to optimise the operational set up of the robot by confirming optimal BSU positions, port placings and procedural steps.…”

“…No procedure required conversion to conventional MAS or open surgery, all procedures were completed successfully and there were no intra-operative complications. The procedures were performed according to the procedural steps described in the preclinical studies, therefore there was no need to modify steps during this clinical phase [18,19]. Intra-operative blood loss was estimated as negligible (< 5 mL) for 19/30 (63.3%) procedures or minimal (< 500 mL) for 11/30 (36.7%) procedures; only one case (3.3%; Case 15) required the use of blood transfusion products (required post-operatively and not related to intra-operative blood loss reported).…”

“…Likewise, the feasibility of Versius for transanal and mesorectal excision has also been evaluated [17]. Additional preclinical studies demonstrated that Versius can be used to successfully complete a range of gynaecological, urological, renal and general surgical procedures in both cadavers and live porcine studies [18][19][20].…”

Robotic‐assisted gynaecological surgery in Australia: current trends, challenges and future possibility

“…However, the rate of uptake of robotic‐assisted surgery in gynaecology will continue to depend on access to quality conventional and robotic surgery training, more cost‐effective robotic surgical systems, patient demand, strengthened credentialing and post‐fellowship training frameworks, and local hospital factors. The emergence of a new range of robotic surgical systems is likely to reduce cost and improve access to RAL technology 29 . Future research should further define the role of robotic‐assisted surgery in gynaecology including the evaluation of the qualitative differences between robotic‐assisted and conventional laparoscopy.…”