Robot-assisted Partial Nephrectomy with the Newly Developed KangDuo Surgical Robot Versus the da Vinci Si Surgical System: A Double-center Prospective Randomized Controlled Noninferiority Trial

Background: The KangDuo surgical robot (KD-SR) was recently developed in China. Objective: To compare the safety and efficacy of the KD-SR versus the da Vinci Si Surgical System (DV-SS-Si) for robot-assisted partial nephrectomy (RAPN). Design, setting,and participants: A double-center prospective randomized controlled noninferiority trial of patients aged 18-75 yr with a suspicion of T1a N0M0 renal cancer (RENAL nephrometry score <9) was conducted. Intervention: RAPN with the KD-SR versus the DV-SS-Si. Outcome measurements and statistical analysis: The primary endpoint was the success rate of operation. The operation was successful if (1) there was no open or laparoscopic conversion, (2) the warm ischemia time was <30 min for RENAL nephrometry scores of 4-6 or 40 min for RENAL nephrometry scores of 7-9, and (3) the pathological margin was negative. The secondary endpoint was the estimated glomerular filtration rate (eGFR). A threshold of 10% was set to demonstrate noninferiority. Results and limitations: From September 2020 to March 2021, 100 participants were enrolled, of whom 99 (49 in the KD-SR group and 50 in the DV-SS-Si group) were finally included in the full analysis set and 98 (49 in the KD-SR group and-49 in the DV-SS-Si group) in the per-protocol set. Baseline demographic and clinical characteristics were similar between the two groups. All surgeries were completed successfully. The eGFR at postoperative weeks 4-12 and adverse events were similar between the two groups. The docking time and suture time per stitch were longer in the KD-SR group. The main limitation was that a negative margin was considered as the primary outcome rather than survival. Conclusions: The KD-SR achieved noninferior outcomes as compared with the DV-SS-Si regarding safety and efficacy for T1a tumors. Patient summary: The first trial comparing the KangDuo surgical robot (KD-SR) versus the da Vinci Si Surgical System for robot-assisted partial nephrectomy showed that the KD-SR is a viable option for minimally invasive treatment of T1a renal tumors. (c) 2022 The Authors. Published by Elsevier B.V. on behalf of European Association of Urology. This is an open access article under the CC BY-NC-ND license (http://creative-commons.org/licenses/by-nc-nd/4.0/).