Use of the KangDuo Surgical Robot-01 (KD-SR-01) system for the management of localized prostate cancer is safe and effective, according to the initial results of a prospective, single-centre study.
“We believe that transperitoneal pelvic lymph node dissection (PLND) could be performed using the KD-SR-01 system safely without pelvic vessel injury, and PLND would be performed further,” said the researchers, led by Shubo Fan from the National Urological Cancer Center in Beijing, China.
This study was conducted from May 2021 to August 2021, involving 16 robot-assisted radical prostatectomy (RARP) procedures with the KD-SR-01 system, which was performed by one surgeon.
The researchers recorded perioperative and follow-up data prospectively and assessed early oncologic outcomes based on surgical margin status. Continence was defined as no more than one pad daily or urine leakage of ≤20 gm by the 24-hour pad weight test. Ergonomics was evaluated using the National Aeronautics and Space Administration Task Load Index (NASA-TLX).
All procedures were performed successfully without converting to traditional RARP, laparoscopic surgery, or open surgery. The median docking time was 5.9 minutes, while console and urethrovesical anastomosis times were 87 and 14.4 minutes, respectively. Blood loss was estimated at a median of 50 ml. Intraoperative transfusion was not warranted in any patient. [J Urol 2022;208:119-127]
The median postoperative hospital stay was 5 days. Four patients (25 percent) had a positive surgical margin overall. Biochemical recurrence did not occur within a month following surgery. At 1 month after catheter removal, the continence rate stood at 87.5 percent (14/16). No severe intra- or postoperative complications (Clavien‒Dindo grade ≥3) was observed.
In addition, the surgeon who performed the procedures reported having high comfort level, with a NASA-TLX global score of 22.7.
“There were no severe perioperative complications or major technical problems, confirming the safety of the KD-SR-01 system,” the researchers said. “The one case of postoperative fever might have been related to poor absorption with the extraperitoneal approach causing exudate to be trapped.”
The KD-SR-01 system features an open surgeon console that improves hand-eye coordination and allows natural and adjustable neck posture. This design frees the neck from a fixed posture, thus relaxing the muscles and preventing neck fatigue.
In addition, the KD-SR-01 system includes grouped surgical arms suspended on a beam designed to adjust to various positions of the patient. While the operating space is limited, the system offers triangulation of the instruments and few collisions of the manipulators. This feature is a result of 3-dimensional, high-definition visual field, grouped manipulators, and 7 degrees of instrument motion.
Finally, the KD-SR-01 system is compatible with commercially available 3-dimensional endoscopy systems, providing excellent visual operative field, clear display of local details, and stereoscopic vision without dizziness. The vision of the KangDuo surgical robot is not a naked 3-dimensional display and requires extra glasses to view the image.
“A larger cohort with longer follow-up is warranted to assess the oncologic and functional outcomes,” the researchers said.