Robot-assisted partial nephrectomy and robot-assisted radical prostatectomy using the Chinese surgical systems KangDuo-SR-2000 and EDGE MP1000 versus the Da Vinci Xi system: a prospective, single-center, non-randomized clinical trial.

Purpose: This study aims to compare the safety and efficacy of robot-assisted partial nephrectomy (RAPN) and robot-assisted radical prostatectomy (RARP) using the Chinese surgical systems KangDuo-SR-2000 (KD-SR-2000) and EDGE MP1000 (MP1000) versus the Da Vinci Xi (DV-Xi) system, to explore viable alternative options to DV-Xi.

Methods: This prospective, single-center, non-randomized clinical trial enrolled 261 patients who underwent RAPN or RARP from August 2023 to June 2024. All surgeries were performed by 3 surgeons. For RAPN, the primary outcome included surgical success, positive surgical margin (PSM), warm ischemia time (WIT) and conversion to open or laparoscopic surgery. The secondary outcome was estimated glomerular filtration rate (eGFR). For RARP, the primary outcome was surgical success without conversion to open or laparoscopic surgery, and the secondary outcomes included PSM and urinary continence recovery at 4 weeks post-catheter removal.

Results: Baseline demographics were comparable across the KD-SR-2000 group (n = 88), EDGE MP1000 group (n = 59) and DV-Xi group (n = 114). No significant differences observed in primary and secondary outcomes. However, operation time and suture time per stitch were longer in Chinese surgical systems for both RAPN and RARP compared to DV-Xi, and estimated blood loss (EBL) is higher in RAPN. Subgroup analyses indicated that performance differences were primarily attributed to the KD-SR-2000, with no significant differences observed between the MP1000 and DV-Xi. No severe complications (Clavien-Dindo grade ≥ 3) reported in any group.

Conclusions: Chinese surgical systems provide a viable alternative, demonstrating non-inferiority compared to DV-Xi.

Trial registration number: ChiCTR2300074914; Registration Date: 2023-08-21.