全国范围内实施优化的标准化右半结肠癌技术：一项干预性序贯队列研究（Right 研究）方案。
National implementation of an optimal standardised technique for right-sided colon cancer: protocol of an interventional sequential cohort study (Right study).
机构信息
Department of Surgery, Amsterdam UMC Location Vrije Universiteit Amsterdam, De Boelelaan 1117, Amsterdam, The Netherlands.
Cancer Center Amsterdam, Treatment and Quality of Life, Amsterdam, The Netherlands.
出版信息
Tech Coloproctol. 2023 Nov;27(11):1083-1090. doi: 10.1007/s10151-023-02801-6. Epub 2023 Apr 25.
PURPOSE
Minimally invasive right hemicolectomy (MIRH) is the cornerstone of treatment for patients with right-sided colon cancer. This operation has evolved during recent decades, with many innovations and improvements but this has also resulted in high variability of uptake with subsequent substantial variableness. The aim of this ongoing study is to identify current surgical variations, determine the most optimal and standardised MIRH and nationally train and implement that technique to improve short-term clinical and long-term oncological outcomes.
METHODS
The Right study is a national multicentre prospective interventional sequential cohort study. Firstly, current local practice was evaluated. Subsequently, a standardised surgical technique for right-sided colon cancer was determined using the Delphi consensus method, and this procedure was trained during hands-on courses. The standardised MIRH will be implemented with proctoring (implementation cohort), after which the performance will be monitored (consolidation cohort). Patients who will receive a minimally invasive (extended) right hemicolectomy for cT1-3N0-2M0 colon cancer will be included. The primary outcome is patient safety reflected in the 90-day overall complication rate according to the Clavien-Dindo classification. Secondary outcomes will include intraoperative complications, 90-day mortality rate, number of resected tumour-positive lymph nodes, completeness of mesocolic excision, surgical quality score, locoregional and distant recurrence and 5-year overall survival. A total number of 1095 patients (365 per cohort) will be included.
DISCUSSION
The Right study is designed to safely implement the best surgical practice concerning patients with right-sided colon cancer aiming to standardise and improve the surgical quality of MIRH at a national level.
TRIAL REGISTRATION
ClinicalTrials.gov: NCT04889456, May 2021.
目的
微创右半结肠切除术（MIRH）是治疗右侧结肠癌患者的基石。 近几十年来，这项手术不断发展，创新和改进层出不穷，但这也导致了接受率的高度差异，继而导致了很大的变异性。 本正在进行的研究旨在确定当前的手术差异，确定最佳和标准化的 MIRH，并在全国范围内培训和实施该技术，以改善短期临床和长期肿瘤学结果。
方法
Right 研究是一项全国多中心前瞻性干预性序贯队列研究。 首先，评估了当前的本地实践。 随后，使用 Delphi 共识方法确定了标准化的右半结肠癌手术技术，并通过实践课程进行了培训。 将在有监督的情况下实施标准化的 MIRH（实施队列），之后将监测其实施情况（巩固队列）。 将纳入接受微创（扩展）右半结肠切除术治疗 cT1-3N0-2M0 结肠癌的患者。 主要结局是根据 Clavien-Dindo 分类反映的患者安全性，即 90 天总体并发症发生率。 次要结局包括术中并发症、90 天死亡率、切除的肿瘤阳性淋巴结数量、中结肠系膜切除的完整性、手术质量评分、局部和远处复发以及 5 年总生存率。 将纳入 1095 例患者（每个队列 365 例）。
讨论
Right 研究旨在安全地实施针对右侧结肠癌患者的最佳手术实践，旨在标准化和提高全国范围内 MIRH 的手术质量。
试验注册
ClinicalTrials.gov：NCT04889456，2021 年 5 月。
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