{"title":"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","authors":"Xueli Hu, Mengjia Ruan, Luoyi Zhu, Menghan Huang, Lifang Qi, Min Huang, Shuangwei Zou, Lili Lin, Wenwen Zheng, Lizhi Wang, Ping Duan","doi":"10.1002/rcs.2657","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Background</h3>\n \n <p>The Shurui® system (SR-ENS-600) is a novel fully integrated single-port robotic system with bioinspired serpentine surgical manipulators and a camera.</p>\n </section>\n \n <section>\n \n <h3> Methods</h3>\n \n <p>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.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>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.</p>\n </section>\n \n <section>\n \n <h3> Conclusions</h3>\n \n <p>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.</p>\n </section>\n \n <section>\n \n <h3> Registration number</h3>\n \n <p>ChiCTR2300075431. URL: https://www.chictr.org.cn/showproj.html?proj=189995.</p>\n </section>\n </div>","PeriodicalId":50311,"journal":{"name":"International Journal of Medical Robotics and Computer Assisted Surgery","volume":null,"pages":null},"PeriodicalIF":2.3000,"publicationDate":"2024-09-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"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\",\"authors\":\"Xueli Hu, Mengjia Ruan, Luoyi Zhu, Menghan Huang, Lifang Qi, Min Huang, Shuangwei Zou, Lili Lin, Wenwen Zheng, Lizhi Wang, Ping Duan\",\"doi\":\"10.1002/rcs.2657\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div>\\n \\n \\n <section>\\n \\n <h3> Background</h3>\\n \\n <p>The Shurui® system (SR-ENS-600) is a novel fully integrated single-port robotic system with bioinspired serpentine surgical manipulators and a camera.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Methods</h3>\\n \\n <p>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.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Results</h3>\\n \\n <p>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.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Conclusions</h3>\\n \\n <p>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.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Registration number</h3>\\n \\n <p>ChiCTR2300075431. URL: https://www.chictr.org.cn/showproj.html?proj=189995.</p>\\n </section>\\n </div>\",\"PeriodicalId\":50311,\"journal\":{\"name\":\"International Journal of Medical Robotics and Computer Assisted Surgery\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":2.3000,\"publicationDate\":\"2024-09-20\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"International Journal of Medical Robotics and Computer Assisted Surgery\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://onlinelibrary.wiley.com/doi/10.1002/rcs.2657\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"SURGERY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Journal of Medical Robotics and Computer Assisted Surgery","FirstCategoryId":"3","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1002/rcs.2657","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"SURGERY","Score":null,"Total":0}
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
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.
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.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
