Minimally invasive versus conventional sternotomy for Mitral valve repair: protocol for a multicentre randomised controlled trial (UK Mini Mitral)
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...
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2021-04-01
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| author | Richard Graham Paul Modi Enoch Akowuah Joseph Zacharias Luke Vale Massimo Caputo Serban Stoica Max Baghai Ranjit Deshpande Olaf Wendler Adetayo S Kasim Malcolm Dalrymple-Hay Clinton Lloyd Vipin Zamvar Gavin J Murphy Hunaid A Vohra Helen C Hancock Rebecca H Maier Andrew Goodwin Antony Walker Grzegorz Laskawski Simon Kendall Renzo Pessotto Roberto Casula Franco Ciulli Gunaratnam Niranjan Prakash P Punjabi Leanne Marsay Cristina Fernandez-Garcia Bilal H Kirmani Mark D Pullan Andrew D Muir Dimitrios Pousios |
| author_facet | Richard Graham Paul Modi Enoch Akowuah Joseph Zacharias Luke Vale Massimo Caputo Serban Stoica Max Baghai Ranjit Deshpande Olaf Wendler Adetayo S Kasim Malcolm Dalrymple-Hay Clinton Lloyd Vipin Zamvar Gavin J Murphy Hunaid A Vohra Helen C Hancock Rebecca H Maier Andrew Goodwin Antony Walker Grzegorz Laskawski Simon Kendall Renzo Pessotto Roberto Casula Franco Ciulli Gunaratnam Niranjan Prakash P Punjabi Leanne Marsay Cristina Fernandez-Garcia Bilal H Kirmani Mark D Pullan Andrew D Muir Dimitrios Pousios |
| author_sort | Richard Graham |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-93bf8c5ba1074b389cf5ac6c5eb8086a |
| institution | Kabale University |
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| language | English |
| publishDate | 2021-04-01 |
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| spelling | doaj-art-93bf8c5ba1074b389cf5ac6c5eb8086a2024-11-18T03:15:09ZengBMJ Publishing GroupBMJ Open2044-60552021-04-0111410.1136/bmjopen-2020-047676Minimally invasive versus conventional sternotomy for Mitral valve repair: protocol for a multicentre randomised controlled trial (UK Mini Mitral)Richard Graham0Paul Modi1Enoch Akowuah2Joseph Zacharias3Luke Vale4Massimo Caputo5Serban Stoica6Max Baghai7Ranjit Deshpande8Olaf Wendler9Adetayo S Kasim10Malcolm Dalrymple-Hay11Clinton Lloyd12Vipin Zamvar13Gavin J Murphy14Hunaid A Vohra15Helen C Hancock16Rebecca H Maier17Andrew Goodwin18Antony Walker19Grzegorz Laskawski20Simon Kendall21Renzo Pessotto22Roberto Casula23Franco Ciulli24Gunaratnam Niranjan25Prakash P Punjabi26Leanne Marsay27Cristina Fernandez-Garcia28Bilal H Kirmani29Mark D Pullan30Andrew D Muir31Dimitrios Pousios32Cardiothoracic Surgery, South Tees Hospitals NHS Foundation Trust, Middlesbrough, UKCardiothoracic Surgery, Liverpool Heart and Chest Hospital NHS Foundation Trust, Liverpool, UK1Academic Cardiovascular Unit, South Tees NHS Foundation Trust, Middlesbrough, TS4 3BW, UKThe Lancashire Cardiac Centre, Blackpool Teaching Hospitals NHS Foundation Trust, Blackpool, UKNewcastle University Population Health Sciences Institute, Newcastle upon Tyne, UK1 Bristol Medical School, University of Bristol, Bristol, UKBristol Heart Institute, University of Bristol, Bristol, UKDepartment of Cardiac Surgery, King’s College Hospital, London, UKCardiothoracic Surgery, Kings College Hospital NHS Foundation Trust, London, UKCardiothoracic Surgery, King`s College Hospital, King`s Health Partners, London, UKWolfson Research Institute for Health and Wellbeing, Durham University, Stockton-on-Tees, UKCardiothoracic Surgery, University Hospitals Plymouth NHS Trust, Plymouth, UKCardiothoracic Surgery, University Hospitals Plymouth NHS Trust, Plymouth, UKCardiothoracic Surgery, Royal Infirmary of Edinburgh, Edinburgh, UK1 Department of Cardiovascular Sciences, University of Leicester, Leicester, UKCardiothoracic Surgery, University Hospitals Bristol NHS Foundation Trust, Bristol, UK7 Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UKNewcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UKCardiothoracic Surgery, South Tees Hospitals NHS Foundation Trust, Middlesbrough, UKThe Lancashire Cardiac Centre, Blackpool Teaching Hospitals NHS Foundation Trust, Blackpool, UKThe Lancashire Cardiac Centre, Blackpool Teaching Hospitals NHS Foundation Trust, Blackpool, UKDepartment of Cardiac Surgery, James Cook University Hospital, Middlesbrough, UKCardiothoracic Surgery, Royal Infirmary of Edinburgh, Edinburgh, UKCardiothoracic Surgery, Imperial College Healthcare NHS Trust, London, UKCardiothoracic Surgery, University Hospitals Bristol NHS Foundation Trust, Bristol, UKCardiac Surgery, Liverpool Heart and Chest Hospital NHS Foundation Trust, Liverpool, UKCardiothoracic Surgery, Imperial College Healthcare NHS Trust, London, UKNewcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UKPopulation Health Sciences Institute, Newcastle University Faculty of Medical Sciences, Newcastle upon Tyne, UKCardiothoracic Surgery, Liverpool Heart and Chest Hospital NHS Foundation Trust, Liverpool, UKCardiothoracic Surgery, Liverpool Heart and Chest Hospital NHS Foundation Trust, Liverpool, UKCardiothoracic Surgery, Liverpool Heart and Chest Hospital NHS Foundation Trust, Liverpool, UKCardiothoracic Surgery, Liverpool Heart and Chest Hospital NHS Foundation Trust, Liverpool, UKIntroduction 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.https://bmjopen.bmj.com/content/11/4/e047676.full |
| spellingShingle | Richard Graham Paul Modi Enoch Akowuah Joseph Zacharias Luke Vale Massimo Caputo Serban Stoica Max Baghai Ranjit Deshpande Olaf Wendler Adetayo S Kasim Malcolm Dalrymple-Hay Clinton Lloyd Vipin Zamvar Gavin J Murphy Hunaid A Vohra Helen C Hancock Rebecca H Maier Andrew Goodwin Antony Walker Grzegorz Laskawski Simon Kendall Renzo Pessotto Roberto Casula Franco Ciulli Gunaratnam Niranjan Prakash P Punjabi Leanne Marsay Cristina Fernandez-Garcia Bilal H Kirmani Mark D Pullan Andrew D Muir Dimitrios Pousios Minimally invasive versus conventional sternotomy for Mitral valve repair: protocol for a multicentre randomised controlled trial (UK Mini Mitral) BMJ Open |
| title | Minimally invasive versus conventional sternotomy for Mitral valve repair: protocol for a multicentre randomised controlled trial (UK Mini Mitral) |
| title_full | Minimally invasive versus conventional sternotomy for Mitral valve repair: protocol for a multicentre randomised controlled trial (UK Mini Mitral) |
| title_fullStr | Minimally invasive versus conventional sternotomy for Mitral valve repair: protocol for a multicentre randomised controlled trial (UK Mini Mitral) |
| title_full_unstemmed | Minimally invasive versus conventional sternotomy for Mitral valve repair: protocol for a multicentre randomised controlled trial (UK Mini Mitral) |
| title_short | Minimally invasive versus conventional sternotomy for Mitral valve repair: protocol for a multicentre randomised controlled trial (UK Mini Mitral) |
| title_sort | minimally invasive versus conventional sternotomy for mitral valve repair protocol for a multicentre randomised controlled trial uk mini mitral |
| url | https://bmjopen.bmj.com/content/11/4/e047676.full |
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