Comparing the KangDuo Surgical Robot-01 and da Vinci Xi system for endometrial cancer surgery: a multi-center, randomized, parallel-controlled, noninferiority trial

摘要

BACKGROUND: The outcomes of patients who undergo surgical staging for endometrial cancer using the KangDuo Surgical Robot-01 (KD-SR-01) have not been compared with those of patients who undergo this procedure using the da Vinci Xi system. The aim of this study is to evaluate the efficacy and safety of the KD-SR-01 system for surgical staging of endometrial cancer by comparing short-term outcomes to those of counterparts who underwent surgery using the da Vinci Xi system. MATERIALS AND METHODS: This multi-center, randomized, noninferiority trial was conducted at four hospitals. Overall, 99 patients aged 18-80 years with endometrial cancer were enrolled between May 2022 and June 2023. Participants were randomized to receive surgical staging using either the KD-SR-01 (KD group) or da Vinci Xi system (DV group). The primary endpoint was the surgical success rate. The secondary endpoints were the number of harvested lymph nodes and surgical satisfaction. Safety evaluation included the docking time, console time, intraoperative blood loss, and complications. The follow-up period was 6 weeks. RESULTS: All surgeries were completed without converting to open or other laparoscopic procedures. No significant difference was noted in the number of dissected lymph nodes between the KD and DV groups (13.29 vs. 16.92, P = 0.10). Per the National Aeronautics and Space Administration task load index, significant differences were found between the groups only in performance and frustration ( P < 0.05) but not in the other categories. Compared to patients in the DV group, no significant differences were observed in console time, intraoperative blood loss, or complications in the KD group ( P > 0.05). Only the docking time was longer in the latter (5.39 vs. 4.34 minutes, P = 0.01). CONCLUSION: The clinical application of the KD-SR-01 system for endometrial cancer staging surgery is safe and effective, with short-term results comparable to those achieved with the da Vinci Xi system after sufficient training.