Background and objective: The Hugo RAS and DaVinci Xi systems are used for performing robot-assisted radical prostatectomy (RARP). This study aims to compare these two platforms providing granular and comprehensive data on their intraoperative performance. Methods: The Comparison of Outcomes of Multiple Platforms for Assisted Robotic surgery-Prostate (COMPAR-P) trial is a prospective post-market study (clinicaltrials.org NCT05766163). Enrollment began in March 2023, allocating patients to DaVinci or Hugo RAS for RARP, without selection criteria, for up to 50 consecutive cases. Two experienced console surgeons performed the procedures, following the same technique. Evaluation focused on timing, learning curves, malfunctioning events, complications, and users' satisfaction, using standard statistical methods, including the cumulative summation analysis (CUSUM) for the learning curve assessment. Key findings and limitations: Fifty patients each were enrolled for DaVinci (DV-RARP) and Hugo RAS (H-RARP) RARP. Baseline features were balanced. DV-RARP showed significantly shorter "setup" and "console" phase durations than H-RARP (37 vs 55 min and 97 vs 126 min, respectively, p < 0.001). A longitudinal timing analysis revealed DV-RARP's flat line, while H-RARP showed a modest decline with breakpoints at 22 and 17 procedures by CUSUM for the setup and console phases. The numbers of malfunctioning events were 4 (DV-RARP) and 20 (H-RARP). DV-RARP had high user satisfaction, while the user satisfaction of H-RARP varied. The comparison was between the first 50 H-RARP and the last 50 DV-RARP cases performed at our institution. This likely accounts for the observed differences in setup and console times between the cohorts. The specialized expertise of the surgeons involved could limit the generalizability of our findings. Conclusions and clinical implications: This prospective study compared unselected patients who underwent DV-RARP and H-RARP. More malfunctioning events occurred in case of Hugo RAS, but surgical outcomes were similar. Longer operative times for Hugo RAS were attributed to meticulous care with the novel platform. Improvement potential was evident within a few procedures, providing valuable insights for adopting this new platform. Patient summary: This study compared two advanced robotic systems, DaVinci and Hugo RAS, used to remove the prostate in patients diagnosed with prostate cancer. While both systems showed similar surgical outcomes, the newer Hugo RAS system required more meticulous movements, leading to slightly longer operation times. The findings suggest that, with further experience, both systems can provide effective treatment options for patients undergoing prostate surgery.

Intraoperative Performance of DaVinci Versus Hugo RAS During Radical Prostatectomy: Focus on Timing, Malfunctioning, Complications, and User Satisfaction in 100 Consecutive Cases (the COMPAR-P Trial)

Antonelli, Alessandro
;
Malandra, Sarah;De Marco, Vincenzo;Baielli, Alberto;Franceschini, Andrea;Fumanelli, Francesca;Montanaro, Francesca;Palumbo, Iolanda;Pettenuzzo, Greta;Roggero, Luca;Angela Cerruto, Maria;Bertolo, Riccardo
2024-01-01

Abstract

Background and objective: The Hugo RAS and DaVinci Xi systems are used for performing robot-assisted radical prostatectomy (RARP). This study aims to compare these two platforms providing granular and comprehensive data on their intraoperative performance. Methods: The Comparison of Outcomes of Multiple Platforms for Assisted Robotic surgery-Prostate (COMPAR-P) trial is a prospective post-market study (clinicaltrials.org NCT05766163). Enrollment began in March 2023, allocating patients to DaVinci or Hugo RAS for RARP, without selection criteria, for up to 50 consecutive cases. Two experienced console surgeons performed the procedures, following the same technique. Evaluation focused on timing, learning curves, malfunctioning events, complications, and users' satisfaction, using standard statistical methods, including the cumulative summation analysis (CUSUM) for the learning curve assessment. Key findings and limitations: Fifty patients each were enrolled for DaVinci (DV-RARP) and Hugo RAS (H-RARP) RARP. Baseline features were balanced. DV-RARP showed significantly shorter "setup" and "console" phase durations than H-RARP (37 vs 55 min and 97 vs 126 min, respectively, p < 0.001). A longitudinal timing analysis revealed DV-RARP's flat line, while H-RARP showed a modest decline with breakpoints at 22 and 17 procedures by CUSUM for the setup and console phases. The numbers of malfunctioning events were 4 (DV-RARP) and 20 (H-RARP). DV-RARP had high user satisfaction, while the user satisfaction of H-RARP varied. The comparison was between the first 50 H-RARP and the last 50 DV-RARP cases performed at our institution. This likely accounts for the observed differences in setup and console times between the cohorts. The specialized expertise of the surgeons involved could limit the generalizability of our findings. Conclusions and clinical implications: This prospective study compared unselected patients who underwent DV-RARP and H-RARP. More malfunctioning events occurred in case of Hugo RAS, but surgical outcomes were similar. Longer operative times for Hugo RAS were attributed to meticulous care with the novel platform. Improvement potential was evident within a few procedures, providing valuable insights for adopting this new platform. Patient summary: This study compared two advanced robotic systems, DaVinci and Hugo RAS, used to remove the prostate in patients diagnosed with prostate cancer. While both systems showed similar surgical outcomes, the newer Hugo RAS system required more meticulous movements, leading to slightly longer operation times. The findings suggest that, with further experience, both systems can provide effective treatment options for patients undergoing prostate surgery.
2024
DaVinci
Hugo RAS
Performance
Radical prostatectomy
Robotic surgery
Surgical outcomes
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11562/1124475
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