新型机器人手术系统辅助根治性前列腺切除术的可行性、安全性和有效性：一项前瞻性、对照、随机临床试验。
Feasibility, safety and effectiveness of robot-assisted radical prostatectomy with a new robotic surgical system: a prospective, controlled, randomized clinical trial.
机构信息
Department of Urology, Peking Union Medical College, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, 100730, China.
Department of Allergy, Peking Union Medical College, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China.
出版信息
BMC Cancer. 2024 Sep 27;24(1):1194. doi: 10.1186/s12885-024-12855-w.
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.
背景
机器人辅助根治性前列腺切除术（RARP）在前列腺癌（PCa）的外科治疗中越来越受欢迎，但由于其昂贵的费用而受到挑战。已经开发出一种国产机器人系统来解决这个问题，但缺乏将国产机器人与广泛使用的机器人进行比较的数据。我们进行了一项随机临床试验，比较了 KD-SR-01 机器人和达芬奇机器人在 RARP 中的围手术期、短期肿瘤学和功能结果。
材料和方法
我们前瞻性地招募了患有临床局限性 PCa 的患者。患者被随机分配接受 KD-SR-01-RARP（K-RARP）或达芬奇-RARP（D-RARP），由同一名手术团队进行。收集并比较了基线、围手术期、短期肿瘤学和尿功能数据。
结果
我们共纳入 39 例患者，其中 20 例接受 K-RARP，19 例接受 D-RARP。两组患者的一般资料和肿瘤特征无差异。所有手术均成功完成，无中转开放。手术时间相似（P=0.095），K-RARP 术中出血量较少（P<0.001）。K-RARP 组有 4 例和 D-RARP 组有 3 例发生术后并发症（P=0.732）。K-RARP 组引流量较少（P=0.022）。K-RARP 组有 3 例和 D-RARP 组有 5 例出现阳性切缘（P=0.451）。随访期间，K-RARP 组有 1 例和 D-RARP 组有 2 例患者出现可测量的前列腺特异性抗原（P=0.605）。术后 6 周时，两组的尿漏、尿控和尿垫使用情况相似。
结论
两种手术机器人在可行性、安全性以及短期肿瘤学和功能疗效方面对 RARP 均有相似的结果。
试验注册
该试验于 2022 年 2 月 25 日在中国临床试验注册中心注册，注册号为 ChiCTR2200057000。
Zotero 插件