Abstract
Background
The comparative adoption of the Hugo™ robotic-assisted surgery platform for robot-assisted radical prostatectomy (RARP) is increasing; however, the strength and consistency of prospective head-to-head evidence versus da Vinci® remain uncertain. We performed a systematic review and meta-analysis of prospective comparative studies comparing Hugo™ RAS with da Vinci® for localized prostate cancer, incorporating sensitivity analyses and GRADE certainty assessments.Methods
We searched PubMed, Embase, Scopus, Web of Science, CENTRAL, and ClinicalTrials.gov databases from inception to January 2026. Prospective comparative studies enrolling patients with localized prostate cancer undergoing RARP with Hugo™ versus da Vinci® were included in this review. Screening and extraction were performed in duplicate with consensus resolution. Random-effects meta-analyses were performed, and risk of bias was assessed using ROBINS I and certainty using GRADE.Results
Three prospective comparative studies comprising 145 Hugo RAS cases and 145 da Vinci cases were included. The primary outcome, intraoperative complications, showed no statistically significant difference between Hugo™ RAS and da Vinci®; however, the estimate was imprecise with a wide confidence interval, reflecting limited statistical power and uncertainty around the true effect size (RR 1.95, 95% CI 0.49-7.72; I² 0%). Secondary outcomes also showed no statistically significant differences, including positive surgical margin (RR 1.20, 95% CI 0.49-2.98), operative time (MD - 15.34 min, 95% CI - 41.11 to 10.43), estimated blood loss (MD - 39.09 mL, 95% CI - 143.51 to 65.32; I² 90%), length of stay (MD 0.10 days, 95% CI - 0.02 to 0.22), and catheter duration (MD 0.01 days, 95% CI - 3.97 to 3.99; I² 92%). Leave-one-out sensitivity analysis reduced heterogeneity in blood loss after removing a single study and shifted the pooled estimate toward lower blood loss with Hugo™. The certainty of evidence ranged from moderate to very low, most often downgraded for risk of bias, imprecision, and inconsistency.Conclusions
In the currently available prospective comparative evidence, Hugo™ RAS showed no statistically significant difference from da Vinci® RARP for perioperative safety and early postoperative outcomes in localized prostate cancer. However, the small sample size, sparse events, and wide confidence intervals, particularly for intraoperative complications, preclude conclusions of clinical equivalence or non-inferiority. Larger multicenter prospective comparative studies with standardized outcome definitions and longer oncologic and functional follow-up are required to generate higher-certainty evidence.