遵照IDEAL框架和建议:开展高质量的直肠癌外科临床研究  

Conduct high-quality clinical studies in rectal cancer surgery based upon the IDEAL frame-work and recommendations

作　　者：姚宏伟[1] 高加勒 张忠涛[1] Yao Hongwei;Gao Jiale;Zhang Zhongtao(Department of General Surgery,Beijing Friendship Hospital,Capital Medical University,National Clinical Research Center for Digestive Diseases,Beijing Key Laboratory of Cancer Invasion and Metastasis Research,Clinical Practice and Research Center for Colorectal Cancer,Capital Medical University,Beijing 100050,China)

机构地区：[1]首都医科大学附属北京友谊医院普通外科,国家消化系统疾病临床医学研究中心,肿瘤侵袭和转移机制研究北京市重点实验室,首都医科大学结直肠肿瘤临床诊疗与研究中心,北京100050

出　　处：《中华消化外科杂志》2022年第6期726-729,共4页Chinese Journal of Digestive Surgery

基　　金：国家科技支撑计划课题(2015BAI13B09);国家重点研发计划资助(2017YFC0110904);北京市医院管理局临床医学发展专项基金(ZYLX201504);首都医科大学结直肠肿瘤临床诊疗与研究中心基金项目(1192070313);首都医科大学附属北京友谊医院科研启动基金(YYQDKT2016-5)。

摘　　要：“设计、开发、探索、评价和长期随访(IDEAL)”框架和建议为外科创新技术提供了高质量研究和实践的指导路径。经肛全直肠系膜切除术作为直肠外科领域的一项新技术,其发展严格遵循IDEAL框架并逐步推进。在技术设计和开发阶段,验证了该技术的可行性。在探索阶段,进行小规模临床验证,制订诊断与治疗规范和手术标准,开展结构化培训。在评价阶段,进行大规模随机对照研究,验证该技术的安全性和有效性。随后在临床实践中进行长期监测和随访,成为外科临床研究领域的良好范例。笔者回顾、总结和整理本研究团队在质量控制方面的开创性工作,以飨读者。The idea,development,exploration,assessment,and long-term follow-up(IDEAL)framework and recommendations provide a guiding path for high-quality research and practice for surgical technology innovation.Transanal total mesorectal excision,as a new technology in the field of colorectal surgery,has evolved step by step following the IDEAL framework.At the technical design and development stage,the technique feasibility is verified.At the exploratory stage,small-scale clinical practice is conducted,standardized diagnosis and treatment and surgical technique are developed,and structured training is carried out.During the assessment stage,large-scale rando-mized controlled studies are conducted to confirm the safety and efficacy.Subsequently,long-term monitoring and follow-up of the technique is carried out in clinical practice.All the processes become good example in the field of surgical clinical research.The authors summarize the pioneering works of the research team in quality control,in order to provide references for peers.

关 键 词：直肠肿瘤 IDEAL 外科临床研究 经肛全直肠系膜切除术 外科创新 

分 类 号：R735.37[医药卫生—肿瘤]