这是首例用于妇科手术的新型单孔机器人系统的人体临床试验和前瞻性病例系列研究：IDEAL 阶段 2a 研究。
This is the first in-human trial and prospective case series of a novel single-port robotic system for gynaecological surgery: An IDEAL stage 2a study.
机构信息
Oncology Discipline Group, The Second Affiliated Hospital of Wenzhou Medical University, Wenzhou, China.
Department of Obstetrics and Gynecology, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, China.
出版信息
Int J Med Robot. 2024 Oct;20(5):e2657. doi: 10.1002/rcs.2657.
BACKGROUND
The Shurui® system (SR-ENS-600) is a novel fully integrated single-port robotic system with bioinspired serpentine surgical manipulators and a camera.
METHODS
This was a single-centre prospective case-series study according to the IDEAL stage 2a guidelines to evaluate the feasibility, safety and potential efficacy of the Shurui® system for gynaecological surgeries and to improve the operating process.
RESULTS
Ten patients with a gradient of surgical difficulty who had indications for laparoscopic surgery and who volunteered to participate in a clinical trial were enrolled in the study. All 10 subjects successfully completed the procedure without converting to other procedures. No serious complications were reported at the 3-month follow-up. Subjects recover faster after surgery and are highly satisfied with the incision.
CONCLUSIONS
Gynaecological single-site laparoscopic surgery with the Shurui® system was technically feasible for well-selected patients with minimal alterations in technique. Further prospective multicenter large-sample studies are necessary.
REGISTRATION NUMBER
ChiCTR2300075431. URL: https://www.chictr.org.cn/showproj.html?proj=189995.
背景
Shurui®系统（SR-ENS-600）是一种新型的全集成单孔机器人系统，具有仿生蛇形手术器械和摄像头。
方法
本研究为按照 IDEAL 阶段 2a 指南进行的单中心前瞻性病例系列研究，旨在评估 Shurui®系统用于妇科手术的可行性、安全性和潜在疗效，并改进手术操作流程。
结果
研究纳入了 10 名具有腹腔镜手术适应证且自愿参加临床试验的手术难度梯度患者。所有 10 名受试者均成功完成了手术，无一例转为其他手术。在 3 个月的随访中，无严重并发症发生。术后受试者恢复更快，对切口高度满意。
结论
对于经过精心挑选的患者，Shurui®系统进行妇科单部位腹腔镜手术具有技术可行性，且手术技术的改变较小。需要进一步开展前瞻性多中心大样本研究。
注册号
ChiCTR2300075431. URL：https://www.chictr.org.cn/showproj.html?proj=189995.
Zotero 插件