Conduct high-quality clinical studies in rectal cancer surgery based upon the IDEAL frame-work and recommendations
10.3760/cma.j.cn115610-20220516-00277
- VernacularTitle:遵照IDEAL框架和建议:开展高质量的直肠癌外科临床研究
- Author:
Hongwei YAO
1
;
Jiale GAO
;
Zhongtao ZHANG
Author Information
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
- Keywords:
Rectal neoplasms;
IDEAL;
Surgical clinical research;
Transanal total meso-rectal excision;
Surgical innovation
- From:
Chinese Journal of Digestive Surgery
2022;21(6):726-729
- CountryChina
- Language:Chinese
-
Abstract:
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.