1. Feasibility, safety and effectiveness of robot-assisted radical prostatectomy with a new robotic surgical system: a prospective, controlled, randomized clinical trial.
- Author
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Dong J, Ji R, Cui L, Liu G, Xie Y, Zhou J, Wang H, Xu W, and Ji Z
- Subjects
- Humans, Male, Middle Aged, Aged, Prospective Studies, Treatment Outcome, Operative Time, Postoperative Complications epidemiology, Postoperative Complications etiology, Prostatectomy methods, Prostatectomy adverse effects, Robotic Surgical Procedures methods, Robotic Surgical Procedures adverse effects, Prostatic Neoplasms surgery, Feasibility Studies
- 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., (© 2024. The Author(s).)- Published
- 2024
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