STAR Study - Version 1

  • Research type

    Research Study

  • Full title

    ShorT stay Aneurysm Repair (STAR): A 23-hour endovascular abdominal aortic aneurysm repair pathway with evaluation of eligibility, uptake, viability, acceptability, safety and cost.

  • IRAS ID

    302827

  • Contact name

    Colin Bicknell

  • Contact email

    colin.bicknell@imperial.ac.uk

  • Sponsor organisation

    Imperial College London

  • Clinicaltrials.gov Identifier

    NCT05279274

  • Clinicaltrials.gov Identifier

    N/A, N/A

  • Duration of Study in the UK

    2 years, 0 months, 0 days

  • Research summary

    There has been a failure to implement day case EVAR - patient discharge after endovascular aneurysm repair (EVAR) in <24 hours, on a widespread scale in the UK. There are significant health-economic and trust resource implications associated with longer hospital stay, which are vitally important in discussions regarding the appropriateness of EVAR.

    This study aims to build on previous experience and background studies to formally assess a ShorT stay Aneurysm Repair (STAR) pathway designed to accommodate patient, organisational, community, and social needs and ensure patient safety.

    After careful co-design of a STAR pathway with patients, carers and GPs we plan to assess (in over 200 patients) the eligibility, uptake, viability, acceptability and safety. Consecutive EVAR patients at five sites (target 100 patients) will be assessed for eligibility over 12 months. We shall determine the proportion of patients eligible for and taking up STAR.

    Procedure times, details of procedural intervention, discharge and readmission will be collected to measure viability. Mortality, complications/adverse events (at 30 days, 3, 6 and 12 months), will be used to determine the safety of short stay aneurysm repair.

    Acceptability will be measured by patient related outcome measures and quality of life tools measured at baseline, 30 days, 3 months and 6 months.

    Cost of the pathways (including NHS, social care and societal costs will be measured.

    Barriers to the wider implementation of STAR will be described by complementary qualitative focus group work involving patients and staff.

    From this work we will understand the proportion of patients that could be managed with a STAR pathway safely and we intend to create a web/app based “toolkit” for effective 23-hour EVAR implementation.

  • REC name

    London - Bromley Research Ethics Committee

  • REC reference

    21/PR/1579

  • Date of REC Opinion

    24 Jan 2022

  • REC opinion

    Further Information Favourable Opinion