A risk-adjusted and anatomically stratified cohort comparison study of open surgery, endovascular techniques and medical management for juxtarenal aortic aneurysms-the UK COMPlex AneurySm Study (UK-COMPASS): a study protocol

Shaneel R. Patel, David C. Ormesher, Samuel R. Smith, Kitty H. F. Wong, Paul Bevis, Colin D. Bicknell, Jonathan R. Boyle, John A. Brennan, Bruce Campbell, Andrew Cook, Alastair P. Crosher, Rui V. Duarte, Murray M. Flett, Carrol Gamble, Richard J. Jackson, Maciej T. Juszczak, Ian M. Loftus, Ian M. Nordon, Jai V. Patel, Kellie PlattEftychia-Eirini Psarelli, Peter C. Rowlands, John V. Smyth, Theodoros Spachos, Leigh Taggart, Claire Taylor, Srinivasa Rao Vallabhaneni (Lead / Corresponding author)

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    Abstract

    Introduction: In one-third of all abdominal aortic aneurysms (AAAs), the aneurysm neck is short (juxtarenal) or shows other adverse anatomical features rendering operations more complex, hazardous and expensive. Surgical options include open surgical repair and endovascular aneurysm repair (EVAR) techniques including fenestrated EVAR, EVAR with adjuncts (chimneys/endoanchors) and off-label standard EVAR. The aim of the UK COMPlex AneurySm Study (UK-COMPASS) is to answer the research question identified by the National Institute for Health Research Health Technology Assessment (NIHR HTA) Programme: 'What is the clinical and cost-effectiveness of strategies for the management of juxtarenal AAA, including fenestrated endovascular repair?'

    Methods and analysis: UK-COMPASS is a cohort study comparing clinical and cost-effectiveness of different strategies used to manage complex AAAs with stratification of physiological fitness and anatomical complexity, with statistical correction for baseline risk and indication biases. There are two data streams. First, a stream of routinely collected data from Hospital Episode Statistics and National Vascular Registry (NVR). Preoperative CT scans of all patients who underwent elective AAA repair in England between 1 November 2017 and 31 October 2019 are subjected to Corelab analysis to accurately identify and include every complex aneurysm treated. Second, a site-reported data stream regarding quality of life and treatment costs from prospectively recruited patients across England. Site recruitment also includes patients with complex aneurysms larger than 55 mm diameter in whom an operation is deferred (medical management). The primary outcome measure is perioperative all-cause mortality. Follow-up will be to a median of 5 years.

    Ethics and dissemination: The study has received full regulatory approvals from a Research Ethics Committee, the Confidentiality Advisory Group and the Health Research Authority. Data sharing agreements are in place with National Health Service Digital and the NVR. Dissemination will be via NIHR HTA reporting, peer-reviewed journals and conferences.

    Trial registration number: ISRCTN85731188.

    Original languageEnglish
    Article numbere054493
    Number of pages8
    JournalBMJ Open
    Volume11
    Issue number11
    Early online date30 Nov 2021
    DOIs
    Publication statusPublished - 30 Nov 2021

    Keywords

    • clinical trials
    • protocols & guidelines
    • vascular surgery

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