BMC Cancer (Sep 2024)

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

DOI
https://doi.org/10.1186/s12885-024-12855-w
Journal volume & issue
Vol. 24, no. 1
pp. 1 – 11

Abstract

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Abstract 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.

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