Robot-assisted Partial Nephrectomy with and without Mixed Reality - REALITATEM study

PURPOSE: This randomized clinical trial (RCT) was developed to analyze the efficacy of using Mixed Reality (MIXREAL), the combination of virtual (VR) and augmented realities (AR), in robot-assisted partial nephrectomy (RAPN). MATERIALS AND METHODS: Forty-five patients with renal masses (RM) were allocated to RAPN with or without use of MIXREAL, Realitatem Group (RG) and Control Group (CG), respectively. RESULTS: Analyses indicated statistically significant difference in ischemia time favoring RG (p = 0.045), with a mean difference of 3.8 minutes. Classically, the limit widely accepted as suitable for ischemia time is 20-25 minutes, but every 1 minute saved may reduce renal injury. Analyses also indicated statistically significant difference in decision for selective clamping favoring RG (p = 0.013); main renal artery clamping globally exposes the renal parenchyma to ischemia. The percentage of residual parenchyma after surgery is also an important variable to renal function recovery, and this study presented a trend towards the enucleation technique being facilitated in the RG. No difference was detected regarding complication rate. Despite those results, no difference was detected in both short and long-term renal function outcomes. The small sample is an important drawback. CONCLUSION: This RCT demonstrates the feasibility and safety of MIXREAL in RAPN, as well as its potential to support intraoperative decision-making. It represents the first RCT evaluating MIXREAL in RAPN. Larger studies with longer follow-up are needed to confirm potential functional benefits.