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

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.