EFEx Trial

  • Research type

    Research Study

  • Full title

    Enhancing Fitness with Preoperative Exercise in Colorectal Cancer Surgery (EFEx).

  • IRAS ID

    217858

  • Contact name

    Susan Moug

  • Contact email

    susanmoug@nhs.net

  • Sponsor organisation

    NHS Greater Glasgow and Clyde Clinical Research and Development Central Office

  • Clinicaltrials.gov Identifier

    NCT03336229

  • Duration of Study in the UK

    0 years, 1 months, 26 days

  • Research summary

    Bowel cancer is the third most common cancer in Scotland and surgery is the mainstay of treatment. Unfortunately, a number of patients develop post-operative complications. Approximately 80% occur in those with other health issues (e.g. heart and/or lung disease) – clinically regarded as ‘high-risk patients’ (HRPs). Pre-operative exercise, or prehabilitation, is a promising area with trials reporting improved fitness and reduced post-operative complication rates in patients with bowel cancer. Many trials have excluded HRPs despite them having potentially the most to gain in short- and long-term quality of life. This trial will randomise HRPs with bowel cancer awaiting elective surgery to either a prehabilitation group (individualised strengthening exercises, respiratory muscle training and a walking programme for 4 weeks minimum) or usual care group. The primary aim is to determine the feasibility of using prehabilitation to improve the physical fitness of HRPs before surgery. Secondary aims include assessing the impact on short-term postoperative outcomes including: length of stay in high dependency and intensive care; readmission rate to these facilities; time to medical discharge; hospital length of stay; readmission within 30 days; post-operative morbidity as recorded by the Clavien-Dindo scale; patients’ perceived quality of life, psychological health and frailty score.

  • REC name

    West of Scotland REC 4

  • REC reference

    17/WS/0212

  • Date of REC Opinion

    1 Dec 2017

  • REC opinion

    Further Information Favourable Opinion