Feasibility, safety and effectiveness of robot-assisted radical prostatectomy with a new robotic surgical system: a prospective, controlled, randomized clinical trial.
Jie Dong, Ruoyu Ji, Liang Cui, Guanghua Liu, Yi Xie, Jingmin Zhou, Huizhen Wang, Weifeng Xu, Zhigang Ji
Author Information
Jie Dong: Department of Urology, Peking Union Medical College, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, 100730, China.
Ruoyu Ji: Department of Allergy, Peking Union Medical College, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China.
Liang Cui: Department of Urology, Civil Aviation General Hospital, Civil Aviation Medical College of Peking University, Beijing, China.
Guanghua Liu: Department of Urology, Peking Union Medical College, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, 100730, China.
Yi Xie: Department of Urology, Peking Union Medical College, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, 100730, China.
Jingmin Zhou: Department of Urology, Peking Union Medical College, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, 100730, China.
Huizhen Wang: Department of Operation room, Peking Union Medical College, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China.
Weifeng Xu: Department of Urology, Peking Union Medical College, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, 100730, China. xuweifeng@pumch.cn.
Zhigang Ji: Department of Urology, Peking Union Medical College, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, 100730, China. windslipper@sina.com.
BACKGROUND: Robot-assisted radical prostatectomy (RARP) gains increasing popularity in the surgical management of prostate cancer (PCa) but is challenged by its prohibitive expense. A domestic robotic system has been developed to address this issue, but data comparing the self-developed robot with the widely used robot is lacking. We performed a randomized clinical trial to compare KD-SR-01 and DaVinci robots in terms of perioperative, short-term oncological and functional outcomes in RARP. MATERIALS AND METHODS: We prospectively enrolled patients with clinically localized PCa. patients were randomized to undergo either KD-SR-01-RARP (K-RARP) or DaVinci-RARP (D-RARP) by the same surgical team. The baseline, perioperative, short-term oncologic and urinary functional data were collected and compared. RESULTS: We enrolled 39 patients, including 20 patients undergoing K-RARP and 19 undergoing D-RARP. Demographic and tumor characteristics were comparable between groups. All surgeries were performed successfully with no conversion to open. The operative time was similar (P���=���0.095) and K-RARP offered less volume of intraoperative bleeding (P���<���0.001). Four patients in the K-RARP group and three in the D-RARP group developed postoperative complications (P���=���0.732). patients undergoing K-RARP had less volume of drainage (P���=���0.022). Positive surgical margins were observed in three patients undergoing K-RARP and five undergoing D-RARP (P���=���0.451). During the follow up, one patient receiving K-RARP group and two receiving D-RARP group had measurable prostate specific antigen (P���=���0.605). Urine leakage, urinary control and pad usage were comparable between groups at six weeks post-surgery. CONCLUSIONS: The two surgical robots yielded similar results in feasibility, safety and short-term oncologic and functional efficacy for RARP. TRIAL REGISTRATION: The trial has been registered at www.chictr.org.cn with a registration number of ChiCTR2200057000 on 25th February 2022.
