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

Abstract

Purpose: To investigate the feasibility, safety, and efficacy of the KangDuo Surgical Robot-01 (KD-SR-01) system for robot-assisted radical nephroureterectomy (UTUC). Materials and Methods: This prospective, single-center, single-arm clinical study of patients with 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 surgery or open surgery. The median docking time and console time were 524 (range, 139-963) seconds and 102.2 (range, 55.3-249.3) minutes, respectively. The median estimated blood loss was 40 (range, 10-100) ml. None of the patients required intraoperative blood transfusion. The median postoperative hospital stay was 4 (range, 2-7) days. Intraoperative or postoperative complications (Clavien-Dindo grade I) occurred in 9 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 to patients with re-docking. Conclusions: The KD-SR-01 system was feasible, safe, and effective for robot-assisted radical nephroureterectomy.