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Simvastatin to prevent complications after oesophagectomy v1.0

  • Research type

    Research Study

  • Full title

    Prevention of post-operative complications by using HMG-CoA Reductase Inhibitor in patients undergoing oesophagectomy - A multicentre, randomised, double blind, placebo controlled trial

  • IRAS ID

    180853

  • Contact name

    Murali Shyamsundar

  • Contact email

    murali.shyamsundar@qub.ac.uk

  • Sponsor organisation

    Belfast Health and Social Care Trust

  • Eudract number

    2015-004424-65

  • Duration of Study in the UK

    4 years, 2 months, 9 days

  • Research summary

    Oesphagectomy (removal of food pipe) is a common surgery. 1220 oesophagectomies were performed in 2013 in England and Wales. One in three patients will develop complications. Heart and lung complications account for up to 50% of complications requiring admissions to Intensive Care Units (ICUs). The risk of dying is significantly elevated in these patients when compared to patients who do not suffer these complications. There is also an impact on their long term disability as these patients have physical and mental health issues. There is also a reduced rate of return to employment. There is no proven pharmacotherapy to reduce these complications in patients undergoing oesophagectomy.

    In addition, there is an associated increase in healthcare utilisation costs. ICU is an expensive and limited resource and a bed in ICU costs up to £1500. These patients also have a higher rate of healthcare contacts after discharge.

    Simvastatin belongs to a group of medications licensed to reduce fat levels in the blood. Simvastatin, through its enzyme blocking action, has also been shown to reduce inflammation and reduce cell damage. In various studies it has been shown to reduce the rates of progression of severe infection, death from sepsis, ICU admissions and to be cardioprotective. In a small study conducted by our team, we have shown that simvastatin reduces inflammation in the lungs and reduces the rates of heart, lung and infective complications.

    Based on our studies and other published evidence, we will conduct this multi-centre trial to study the benefits of giving simvastatin to patients before their surgery to reduce heart and lung complications. Simvastatin is a cheap drug and costs less than £5 for the proposed treatment. If proven beneficial, this study has the potential to improve both patient outcomes and reduce costs to the NHS.

  • REC name

    South Central - Berkshire Research Ethics Committee

  • REC reference

    16/SC/0152

  • Date of REC Opinion

    24 Mar 2016

  • REC opinion

    Favourable Opinion