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

Abstract

Purpose: Our goal was to evaluate the feasibility, safety and effectiveness of the KangDuo Surgical Robot-01 (KD-SR-01) system for robot-assisted radical prostatectomy (RARP).

Materials and methods: This prospective, single-center, single-arm clinical study was conducted from May 2021 to August 2021. Sixteen RARP procedures with the KD-SR-01 system were performed by 1 surgeon. The perioperative and followup data were prospectively recorded. Early oncologic outcomes were assessed according to surgical margin status and continence was defined as no more than 1 pad daily or urine leakage of ≤20 gm by the 24-hour pad weight test. Ergonomics were assessed with the NASA-TLX (National Aeronautics and Space Administration Task Load Index).

Results: All cases were completed successfully without conversion to traditional RARP, laparoscopic surgery or open surgery. The median docking time, console time and urethrovesical anastomosis time were 5.9 (range, 2.5-11.5), 87 (range, 70-120) and 14.4 minutes (range, 12.0-25.7), respectively. The median estimated blood loss was 50 ml (range, 10-200). None of patients required intraoperative transfusion. The median postoperative hospital stay was 5 days (range, 4-10). Overall, a positive surgical margin occurred in 4 (25%) patients. No biochemical recurrence occurred within 1 month after surgery. The continence rate was 87.5% (14/16) at 1 month after catheter removal. No severe intraoperative or postoperative complications (Clavien-Dindo grade ≥3) occurred. The surgeon reported a high comfort level with a NASA-TLX global score of 22.7±3.2.

Conclusions: The KD-SR-01 system is feasible, safe and effective for management of localized prostate cancer.

Keywords: prostatic neoplasms; robotic surgical procedures; robotics.