二尖瓣修复的微创与传统胸骨切开术：一项多中心随机对照试验（英国迷你二尖瓣试验）方案
Minimally invasive versus conventional sternotomy for Mitral valve repair: protocol for a multicentre randomised controlled trial (UK Mini Mitral).
作者信息
Maier Rebecca H, Kasim Adetayo S, Zacharias Joseph, Vale Luke, Graham Richard, Walker Antony, Laskawski Grzegorz, Deshpande Ranjit, Goodwin Andrew, Kendall Simon, Murphy Gavin J, Zamvar Vipin, Pessotto Renzo, Lloyd Clinton, Dalrymple-Hay Malcolm, Casula Roberto, Vohra Hunaid A, Ciulli Franco, Caputo Massimo, Stoica Serban, Baghai Max, Niranjan Gunaratnam, Punjabi Prakash P, Wendler Olaf, Marsay Leanne, Fernandez-Garcia Cristina, Modi Paul, Kirmani Bilal H, Pullan Mark D, Muir Andrew D, Pousios Dimitrios, Hancock Helen C, Akowuah Enoch
机构信息
Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK
Department of Anthropology, Durham University, Durham, UK.
出版信息
BMJ Open. 2021 Apr 14;11(4):e047676. doi: 10.1136/bmjopen-2020-047676.
INTRODUCTION
Numbers of patients undergoing mitral valve repair (MVr) surgery for severe mitral regurgitation have grown and will continue to rise. MVr is routinely performed via median sternotomy; however, there is a move towards less invasive surgical approaches.There is debate within the clinical and National Health Service (NHS) commissioning community about widespread adoption of minimally invasive MVr surgery in the absence of robust research evidence; implementation requires investment in staff and infrastructure.The UK Mini Mitral trial will provide definitive evidence comparing patient, NHS and clinical outcomes in adult patients undergoing MVr surgery. It will establish the best surgical approach for MVr, setting a standard against which emerging percutaneous techniques can be measured. Findings will inform optimisation of cost-effective practice.
METHODS AND ANALYSIS
UK Mini Mitral is a multicentre, expertise based randomised controlled trial of minimally invasive thoracoscopically guided right minithoracotomy versus conventional sternotomy for MVr. The trial is taking place in NHS cardiothoracic centres in the UK with established minimally invasive mitral valve surgery programmes. In each centre, consenting and eligible patients are randomised to receive surgery performed by consultant surgeons who meet protocol-defined surgical expertise criteria. Patients are followed for 1 year, and consent to longer term follow-up.Primary outcome is physical functioning 12 weeks following surgery, measured by change in Short Form Health Survey (SF-36v2) physical functioning scale. Early and 1 year echo data will be reported by a core laboratory. Estimates of key clinical and health economic outcomes will be reported up to 5 years.The primary economic outcome is cost effectiveness, measured as incremental cost per quality-adjusted life year gained over 52 weeks following index surgery.
ETHICS AND DISSEMINATION
A favourable opinion was given by Wales REC 6 (16/WA/0156). Trial findings will be disseminated to patients, clinicians, commissioning groups and through peer reviewed publication.
TRIAL REGISTRATION NUMBER
ISRCTN13930454.
引言
因严重二尖瓣反流接受二尖瓣修复术（MVr）的患者数量不断增加且将持续上升。MVr通常通过正中胸骨切开术进行；然而，目前正朝着侵入性较小的手术方法发展。在临床和国民医疗服务体系（NHS）委托机构中，对于在缺乏有力研究证据的情况下广泛采用微创MVr手术存在争议；实施该手术需要在人员和基础设施方面进行投资。英国小型二尖瓣试验将提供确凿证据，比较接受MVr手术的成年患者的患者、NHS和临床结局。它将确定MVr的最佳手术方法，为衡量新兴经皮技术设定标准。研究结果将为优化具有成本效益的实践提供参考。
方法与分析
英国小型二尖瓣试验是一项多中心、基于专业知识的随机对照试验，比较微创胸腔镜引导下右小切口开胸术与传统胸骨切开术治疗MVr的效果。该试验在英国设有成熟的微创二尖瓣手术项目的NHS心胸中心进行。在每个中心，符合条件并同意参与的患者被随机分配接受由符合方案定义的手术专业标准的顾问外科医生进行的手术。对患者进行1年的随访，并征得其同意进行长期随访。主要结局是术后12周的身体功能，通过简短健康调查问卷（SF - 36v2）身体功能量表的变化来衡量。早期和1年的超声心动图数据将由核心实验室报告。关键临床和健康经济结局的评估将报告至5年。主要经济结局是成本效益，以首次手术术后52周内每获得一个质量调整生命年的增量成本来衡量。
伦理与传播
威尔士研究伦理委员会6（16/WA/0156）给出了肯定意见。试验结果将向患者、临床医生、委托机构公布，并通过同行评审发表。
试验注册号
ISRCTN13930454。
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