Robot-Assisted Radical Nephroureterectomy Using the KangDuo-Surgical Robot-01 System: A Prospective, Single-Center, Single-Arm Clinical Study.

Purpose: To investigate the feasibility, safety, and efficacy of the KangDuo-Surgical Robot-01 (KD-SR-01) system for robot-assisted radical nephroureterectomy (RARNU). Materials and Methods: This prospective, single-center, single-arm clinical study of patients with upper tract urothelial carcinoma (UTUC) was conducted from August 2022 to July 2023 using the KD-SR-01 system. The perioperative and follow-up data were prospectively recorded. The National Aeronautics and Space Administration task load index was calculated to present ergonomics. The technique was described in detail. Results: A total of 13 patients underwent RARNU. None of the cases conversed to laparoscopic procedure or open procedure. The median docking time and console time were 524 seconds (range 139-963 seconds) and 102.2 minutes (range 55.3-249.3 minutes), respectively. The median estimated blood loss was 40 mL (range 10-100 mL). None of the patients required intraoperative blood transfusion. The median postoperative hospital stay was 4 days (range 2-7 days). Intraoperative or postoperative complications (Clavien-Dindo grade I) occurred in nine patients. The surgeon task load index global score achieved 1.05 ± 1.86. Three patients received the single-docking technique, demonstrating similar perioperative results compared with patients with redocking. The study is registered at www.chictr.org.cn (ChiCTR2200056672). Conclusions: The KD-SR-01 system was feasible, safe, and effective for RARNU.