Laparoscopic Para-oesophageal Hiatal Hernia Repair

  • Research type

    Research Study

  • Full title

    Laparoscopic Para-oesophageal Hiatal Hernia Repair: A Single Centre Cohort Study Investigating the Effect on Cardiorespiratory Function and Quality of Life

  • IRAS ID

    276327

  • Contact name

    Richard J McGregor

  • Contact email

    richard.mcgregor@ed.ac.uk

  • Sponsor organisation

    University of Edinburgh

  • Clinicaltrials.gov Identifier

    N/A, N/A

  • Duration of Study in the UK

    3 years, 0 months, 1 days

  • Research summary

    Hiatal surgery is usually undertaken to manage gastrointestinal symptoms, such as reduced appetite, vomiting after eating, regurgitation and upper abdominal pain. Increasingly, patients are referred from colleagues in Respiratory medicine and Cardiology for consideration of surgery to improve cardio-respiratory symptoms such as breathlessness, which can limit day to day activities. Currently there is limited evidence regarding the effect of hiatal surgery on cardio-respiratory outcomes.

    Our research question is to ask whether hiatal hernia surgery will improve cardio-respiratory function, and in turn lead to measurable improvements in functional performance and quality of life measures (in addition to established improvements in gastrointestinal symptoms).

    All patients undergoing elective para-oesophageal hiatial hernia repair at the Edinburgh Royal Infirmary will be eligible for this prospective, single centre, cohort study. We envisage the study will run for 3 years in order to collect sufficient data for statistically analysis. There will be no change to the standard of care i.e. laparoscopic (key hole) repair. The study will have the dual function of measuring patient centered outcomes, alongside objective assessments of cardio-respiratory function.

  • REC name

    West Midlands - Solihull Research Ethics Committee

  • REC reference

    20/WM/0074

  • Date of REC Opinion

    31 Mar 2020

  • REC opinion

    Further Information Favourable Opinion