引用文本：孙凯, 牟廷裕, 王亚楠, 等. 从单切口腹腔镜手术研发历程探讨IDEAL理论框架——浅谈外科临床研究的方法学指引[J/CD]. 消化肿瘤杂志（电子版）, 2025, 17(4): 460-464.

作者：孙凯，牟廷裕，王亚楠，邓海军

单位：南方医科大学南方医院普外科，广东 广州 510515

Authors：Sun Kai, Mou Tingyu, Wang Yanan, Deng Haijun

Unit：Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou 510515, Guangdong, China

摘要：

“设计（idea）、开发（development）、探索（exploration）、评价（assessment）和长期随访（long-term follow-up）”的IDEAL框架和建议为外科创新技术提供了高质量研究和临床实践的基本指导路径。单切口腹腔镜手术（single-incision laparoscopic surgery，SILS）作为微创外科领域的一项创新技术，其发展严格遵循IDEAL科学流程并逐步推进。这一术式的设计灵感源于临床实操的客观需求，实物的成功开发依托于跨学科的专业合作和产学研落地，由此验证了技术设计的可行性。在探索阶段，首先进行小规模临床试验，制订操作规范和手术标准，并开展结构化培训。在评价阶段，则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，使SILS成为外科临床研究领域的良好范例。本文通过回顾、总结和整理笔者研究团队在该技术研发中的开创性工作，以启迪思考，推动国际最新方法学指引在国内外科临床研究领域的传播和应用。

关键词：外科临床研究；单切口腹腔镜手术；外科创新

Abstract：

The IDEAL framework, which comprises idea, development, exploration, assessment, and long-term follow-up, provides essential methodological guidance for high-quality research and clinical practice in the context of innovative surgical techniques. Single-incision laparoscopic surgery (SILS), as an innovative technique in the field of minimally invasive surgery, has been developed in strict accordance with the scientifically structured process of the IDEAL framework. Its design was inspired by clinical needs, and its successful development relied on interdisciplinary collaboration and translation from research to practical application, thereby validating the feasibility of the technical design. During the exploration phase, preliminary small-scale clinical studies were conducted to establish procedural protocols and surgical standards, followed by structured training programs. During the assessment phase, a large-scale randomized controlled trial was conducted to evaluate the safety and feasibility of the technique. Subsequently, long-term follow-up was carried out, establishing it as a vivid model in the field of surgical clinical research. In this paper, we reviewed and summarized the pioneering work in the development of SILS technology, aiming to stimulate discussion and promote the dissemination and application of the latest international methodological guidelines within the field of surgical clinical research in China.

Key words：Surgical clinical research; Single-incision laparoscopic surgery; Surgical innovation

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