比较康多手术机器人-01与达芬奇Xi系统用于子宫内膜癌手术：一项多中心、随机、平行对照、非劣效性试验。

Comparing the kangduo surgical robot-01 and da vinci xi system for endometrial cancer surgery: a multi-center, randomized, parallel-controlled, noninferiority trial.

作者信息

Li Yuan, Lv Qiubo, Tang Junying, Du Ming, Wang Tao, Yang Junjun, Yang Jiaxin, Wu Zhangxin, Zhou Dan, Liu Yingwei, Xiao Lin, Guo Hongyan, Xiang Yang

机构信息

National Clinical Research Center for Obstetric & Gynecologic Diseases, Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, PR, China.

Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences.

出版信息

Int J Surg. 2025 Jun 12. doi: 10.1097/JS9.0000000000002728.

DOI:10.1097/JS9.0000000000002728

PMID:40503789

Abstract

BACKGROUND

The outcomes of patients who undergo surgical staging for endometrial cancer using the KangDuo Surgical Robot-01 (KD-SR-01) have not been compared with those of patients who undergo this procedure using the da Vinci Xi system. The aim of this study is to evaluate the efficacy and safety of the KD-SR-01 system for surgical staging of endometrial cancer by comparing short-term outcomes to those of counterparts who underwent surgery using the da Vinci Xi system.

MATERIALS AND METHODS

This multi-center, randomized, noninferiority trial was conducted at four hospitals. Overall, 99 patients aged 18-80 years with endometrial cancer were enrolled between May 2022 and June 2023. Participants were randomized to receive surgical staging using either the KD-SR-01 (KD group) or da Vinci Xi system (DV group). The primary endpoint was the surgical success rate. The secondary endpoints were the number of harvested lymph nodes and surgical satisfaction. Safety evaluation included the docking time, console time, intraoperative blood loss, and complications. The follow-up period was 6 weeks.

RESULTS

All surgeries were completed without converting to open or other laparoscopic procedures. No significant difference was noted in the number of dissected lymph nodes between the KD and DV groups (13.29 vs. 16.92, P = 0.10). Per the National Aeronautics and Space Administration task load index, significant differences were found between the groups only in performance and frustration (P<0.05) but not in the other categories. Compared to patients in the DV group, no significant differences were observed in console time, intraoperative blood loss, or complications in the KD group (P>0.05). Only the docking time was longer in the latter (5.39 vs. 4.34 minutes, P = 0.01).

CONCLUSION

The clinical application of the KD-SR-01 system for endometrial cancer staging surgery is safe and effective, with short-term results comparable to those achieved with the da Vinci Xi system after sufficient training.

摘要

背景

使用康多手术机器人-01（KD-SR-01）对子宫内膜癌进行手术分期的患者的治疗结果，尚未与使用达芬奇Xi系统进行该手术的患者的结果进行比较。本研究的目的是通过比较KD-SR-01系统与使用达芬奇Xi系统进行手术的患者的短期结果，来评估KD-SR-01系统用于子宫内膜癌手术分期的有效性和安全性。

材料与方法

本多中心、随机、非劣效性试验在四家医院进行。2022年5月至2023年6月期间，共纳入99例年龄在18至80岁之间的子宫内膜癌患者。参与者被随机分配接受使用KD-SR-01（KD组）或达芬奇Xi系统（DV组）进行手术分期。主要终点是手术成功率。次要终点是收获的淋巴结数量和手术满意度。安全性评估包括对接时间、控制台操作时间、术中失血量和并发症。随访期为6周。

结果

所有手术均顺利完成，未转为开放手术或其他腹腔镜手术。KD组和DV组之间切除的淋巴结数量无显著差异（13.29个对16.92个，P = 0.10）。根据美国国家航空航天局任务负荷指数，两组之间仅在性能和挫折感方面存在显著差异（P<0.05），在其他类别中无显著差异。与DV组患者相比，KD组在控制台操作时间、术中失血量或并发症方面无显著差异（P>0.05）。只是KD组的对接时间更长（5.39分钟对4.34分钟，P = 0.01）。