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

Xueli Hu, Mengjia Ruan, Luoyi Zhu, Menghan Huang, Lifang Qi, Min Huang, Shuangwei Zou, Lili Lin, Wenwen Zheng, Lizhi Wang, Ping Duan
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Abstract

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.

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这是首次对用于妇科手术的新型单孔机器人系统进行人体试验和前瞻性病例系列研究:IDEAL 2a 阶段研究
背景 Shurui® 系统 (SR-ENS-600) 是一种新型全集成单端口机器人系统,配有生物启发蛇形手术操纵器和摄像头。 方法 这是一项根据 IDEAL 2a 阶段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,并改进手术流程。 结果 10 名手术难度有梯度、有腹腔镜手术适应症并自愿参加临床试验的患者被纳入研究。所有 10 名受试者都顺利完成了手术,没有改用其他手术。在3个月的随访中未发现严重并发症。受试者术后恢复较快,对切口非常满意。 结论 使用 Shurui® 系统进行妇科单部位腹腔镜手术在技术上对经过严格筛选的患者是可行的,对技术的改动很小。有必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.
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来源期刊
CiteScore
4.50
自引率
12.00%
发文量
131
审稿时长
6-12 weeks
期刊介绍: The International Journal of Medical Robotics and Computer Assisted Surgery provides a cross-disciplinary platform for presenting the latest developments in robotics and computer assisted technologies for medical applications. The journal publishes cutting-edge papers and expert reviews, complemented by commentaries, correspondence and conference highlights that stimulate discussion and exchange of ideas. Areas of interest include robotic surgery aids and systems, operative planning tools, medical imaging and visualisation, simulation and navigation, virtual reality, intuitive command and control systems, haptics and sensor technologies. In addition to research and surgical planning studies, the journal welcomes papers detailing clinical trials and applications of computer-assisted workflows and robotic systems in neurosurgery, urology, paediatric, orthopaedic, craniofacial, cardiovascular, thoraco-abdominal, musculoskeletal and visceral surgery. Articles providing critical analysis of clinical trials, assessment of the benefits and risks of the application of these technologies, commenting on ease of use, or addressing surgical education and training issues are also encouraged. The journal aims to foster a community that encompasses medical practitioners, researchers, and engineers and computer scientists developing robotic systems and computational tools in academic and commercial environments, with the intention of promoting and developing these exciting areas of medical technology.
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