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. 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. 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. 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. 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. 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. 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.

Fractional intracellular volume–derived Vascular, Extracellular, and Restricted Diffusion for Cytometry in Tumor analysis of multiparametric MRI findings resulted in better classification of clinic... Background In men suspected of having prostate cancer (PCa), up to 50% of men with positive multiparametric MRI (mpMRI) findings (Prostate Imaging Reporting and Data System [PI-RADS] or Likert scor...

Objectives: To report on the methods, peri‐operative outcomes and histopathological concordance between frozen and final section from the NeuroSAFE PROOF feasibility study (NCT03317990). Patients and Methods: Between May 2018 and March 2019, 49 patients at two UK centres underwent robot‐assisted radical prostatectomy (RARP). Twenty‐five patient were randomized to NeuroSAFE RARP (intervention arm) and 24 to standard RARP (control arm). Frozen section was compared to final paraffin section margin assessment in the 25 patients in the NeuroSAFE arm. Operation timings and complications were collected prospectively in both arms. Results: Fifty neurovascular bundles (NVBs) from 25 patients in the NeuroSAFE arm were analysed. When analysed by each pathological section ( n = 250, average five per side), we noted a sensitivity of 100%, a specificity of 99.2%, and an area under the curve (AUC) of 0.994 (95% confidence interval [CI] 0.985 to 1; P ≤0.001). On an NVB basis ( n = 50), sensitivity was 100%, specificity was 92.7%, and the AUC was 0.963 (95% CI 0.914 to 1; P ≤0.001). NeuroSAFE RARP lasted a mean of 3 h 16 min (knife to skin to off table, 95% CI 3 h 2 min–3 h 30 min) compared to 2 h 4 min (95% CI 2 h 2 min–2 h 25 min; P ≤0.001) for standard RARP. There was no morbidity associated with the additional length of operating time on in the NeuroSAFE arm. Conclusion: This feasibility study demonstrates the safety, reproducibility and excellent histopathological concordance of the NeuroSAFE technique in the NeuroSAFE PROOF trial. Although the technique increases the duration of RARP, this does not cause short‐term harm. Confirmation of feasibility has led to the opening of the fully powered NeuroSAFE PROOF randomized controlled trial, which is currently under way at four sites in the UK.

Background: The accuracy of multi-parametric MRI (mpMRI) in the pre-operative staging of prostate cancer (PCa) remains controversial. Objective: The purpose of this study was to evaluate the ability of mpMRI to accurately predict PCa extra-prostatic extension (EPE) on a side-specific basis using a risk-stratified 5-point Likert scale. This study also aimed to assess the influence of mpMRI scan quality on diagnostic accuracy. Patients and Methods: We included 124 men who underwent robot-assisted RP (RARP) as part of the NeuroSAFE PROOF study at our centre. Three radiologists retrospectively reviewed mpMRI blinded to RP pathology and assigned a Likert score (1–5) for EPE on each side of the prostate. Each scan was also ascribed a Prostate Imaging Quality (PI-QUAL) score for assessing the quality of the mpMRI scan, where 1 represents the poorest and 5 represents the best diagnostic quality. Outcome measurements and statistical analyses: Diagnostic performance is presented for the binary classification of EPE, including 95% confidence intervals and the area under the receiver operating characteristic curve (AUC). Results: A total of 231 lobes from 121 men (mean age 56.9 years) were evaluated. Of these, 39 men (32.2%), or 43 lobes (18.6%), had EPE. A Likert score ≥3 had a sensitivity (SE), specificity (SP), NPV, and PPV of 90.4%, 52.3%, 96%, and 29.9%, respectively, and the AUC was 0.82 (95% CI: 0.77–0.86). The AUC was 0.76 (95% CI: 0.64–0.88), 0.78 (0.72–0.84), and 0.92 (0.88–0.96) for biparametric scans, PI-QUAL 1–3, and PI-QUAL 4–5 scans, respectively. Conclusions: MRI can be used effectively by genitourinary radiologists to rule out EPE and help inform surgical planning for men undergoing RARP. EPE prediction was more reliable when the MRI scan was (a) multi-parametric and (b) of a higher image quality according to the PI-QUAL scoring system.