Robot‐Assisted Radical Prostatectomy Using the KangDuo‐SR‐2000: A Prospective, Multicenter, Single‐Arm Clinical Study

BACKGROUND: This study aimed to evaluate the feasibility, safety and effectiveness of the newly developed KangDuo-Surgical-Robot-2000 (KD-SR-2000) in robotic assisted radical prostatectomy (RARP). METHODS: This prospective, multicenter, single-arm trial was conducted from October 2023 to April 2024. Thirty patients with clinical T1-3 prostate cancer underwent RARP using the KD-SR-2000. The study was approved by the institutional review boards. Perioperative results, early oncologic outcomes, urinary continence, and ergonomic workload (NASA-TLX) were assessed. RESULTS: All surgeries were performed successfully without any conversion. No severe perioperative complications (Clavien-Dindo grade ≥ III) or equipment-related adverse events occurred. Positive surgical margin was observed in five patients (16.7%). One (3.3%) patient experienced PSA persistence at 6 weeks. Urinary continence rate was 66.7% (20/30) at 4 weeks after catheter removal. The median NASA-TLX score was 22.5 (IQR 6-35.25). CONCLUSIONS: This study demonstrates the preliminary feasibility, safety and effectiveness of the KD-SR-2000 robotic system in RARP. TRIAL REGISTRATION: www.chictr.org.cn: ChiCTR2300076954.