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.

Figure 1.

The KangDuo surgical robot. A, the surgeon control console. B, the patient cart. C, the vision cart.

Figure 2.

The interaction of the surgeon and the assistant with the KD-SR-01 system and port placement. A, the surgeon was able to control the open console without flexion of the neck. B, the assistant was stationed at the patient cart with 3 surgical arms suspended on the beam. C, port placement with point Ⅰ for robotic camera, points Ⅱ and Ⅲ for robotic instruments, and points Ⅳ and Ⅴ for the assistant. A 2 cm skin incision about 3–4 cm above the pubic symphysis (point I) was made for initial access into the retropubic space and subsequently as a camera port. A balloon was inserted and insufflated to establish, expand and maintain the retropubic space. Then, 2 extraperitoneal ports were placed about 8 cm from point Ⅰ along the exterior margin of rectus abdomen under direct vision with the left trocar (point Ⅱ) for a bipolar Maryland grasper and the right trocar (point Ⅲ) for a monopolar scissor or large needle driver. Additional ports for auxiliary trocars were placed at the midpoints of the line joining point Ⅱ/Ⅲ and the umbilicus (point Ⅳ/Ⅴ) for retraction, suction and clip placement.

Figure 3.

Surgical technique of RARP with the KD-SR-01 system. A, suturing-ligation of the dorsal venous plexus. B, bladder neck dissection. C, preparation of the seminal vesicles. D, dissection of the rectoprostatic fascia. E, disconnection of the prostatic pedicles. F, disconnection of the urethra. G, posterior muscolofascial reconstruction. H, vesicourethral anastomosis.

Figure 4.

Trend of console time of RARP using the KD-SR-01 system.