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UK Mini Mitral

  • Research type

    Research Study

  • Full title

    Minimally invasive thoracoscopically-guided right minithoracotomy versus conventional sternotomy for mitral valve repair: a multicentre randomised controlled trial (UK Mini Mitral).

  • IRAS ID

    204506

  • Contact name

    Enoch Akowuah

  • Contact email

    enoch.akowuah@nhs.net

  • Sponsor organisation

    South Tees NHS Foundation Trust

  • ISRCTN Number

    ISRCTN13930454

  • Duration of Study in the UK

    4 years, 11 months, 31 days

  • Research summary

    Heart surgery to repair one of the valves in the heart (the mitral valve) is commonly performed in the NHS. Patients needing this operation sometimes suffer symptoms of shortness of breath, tiredness, and swollen ankles, caused by the valve becoming leaky (mitral regurgitation). We need to make sure that the operations offered within the NHS are best for patients. To repair the valve, the operation usually involves cutting the breastbone completely (from the collar bone to the bottom of the breastbone); this is called a sternotomy. An operation has been developed which means that the valve can be repaired using a much smaller cut on the side of the chest; this operation is called a mini-thoracotomy. \n\nThis study will compare the two operations in four hundred adult patients in NHS hospitals in England, to see how well they recover and return to normal activities. Patients will be randomised (allocated) to undergo one of the operations. We will ask participants questions about their physical activities and quality of life before and after their operation. We will also check other factors to see how well patients recover, including how well their valve works after surgery using heart scans (called echocardiograms). We will ask patients to wear a device that measures their activity for one week on seven occasions; the device looks like a wrist-watch and can be worn all day and all night. Any complications following a patient’s operation will be recorded. We will also calculate the costs of care for each operation by looking at medical records to see how often patients are seen in hospital after their operation. Patients who take part will attend hospital a few times in the first year, after this we will continue to check their progress by reviewing their medical notes. \n

  • REC name

    Wales REC 6

  • REC reference

    16/WA/0156

  • Date of REC Opinion

    23 May 2016

  • REC opinion

    Favourable Opinion