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
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) tec...
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2021-11-01
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| author | Rui V Duarte Carrol Gamble Claire Taylor Bruce Campbell Jonathan R Boyle Andrew Cook Srinivasa Rao Vallabhaneni Colin D Bicknell Shaneel R Patel David C Ormesher Samuel R Smith Kitty H F Wong Paul Bevis John A Brennan Alastair P Crosher Murray M Flett Richard J Jackson Maciej T Juszczak Ian M Loftus Ian M Nordon Jai V Patel Kellie Platt Eftychia-Eirini Psarelli Peter C Rowlands John V Smyth Theodoros Spachos Leigh Taggart |
| author_facet | Rui V Duarte Carrol Gamble Claire Taylor Bruce Campbell Jonathan R Boyle Andrew Cook Srinivasa Rao Vallabhaneni Colin D Bicknell Shaneel R Patel David C Ormesher Samuel R Smith Kitty H F Wong Paul Bevis John A Brennan Alastair P Crosher Murray M Flett Richard J Jackson Maciej T Juszczak Ian M Loftus Ian M Nordon Jai V Patel Kellie Platt Eftychia-Eirini Psarelli Peter C Rowlands John V Smyth Theodoros Spachos Leigh Taggart |
| author_sort | Rui V Duarte |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-5e133c8e68024e0fbd0cb34f384fe442 |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2021-11-01 |
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| spelling | doaj-art-5e133c8e68024e0fbd0cb34f384fe4422025-08-20T02:12:11ZengBMJ Publishing GroupBMJ Open2044-60552021-11-01111110.1136/bmjopen-2021-054493A 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 protocolRui V Duarte0Carrol Gamble1Claire Taylor2Bruce Campbell3Jonathan R Boyle4Andrew Cook5Srinivasa Rao Vallabhaneni6Colin D Bicknell7Shaneel R Patel8David C Ormesher9Samuel R Smith10Kitty H F Wong11Paul Bevis12John A Brennan13Alastair P Crosher14Murray M Flett15Richard J Jackson16Maciej T Juszczak17Ian M Loftus18Ian M Nordon19Jai V Patel20Kellie Platt21Eftychia-Eirini Psarelli22Peter C Rowlands23John V Smyth24Theodoros Spachos25Leigh Taggart26Liverpool Reviews and Implementation Group, University of Liverpool, Liverpool, UK4 Clinical Trials Research Centre (CTRC), University of Liverpool, Liverpool, UKLiverpool Clinical Trials Centre, University of Liverpool, Liverpool, UKVascular Surgery, Royal Devon and Exeter Hospital, Exeter, UKVascular Surgery, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UKWessex Institute, University of Southampton, Southampton, UKVascular Surgery, Liverpool University Hospitals NHS Foundation Trust, Liverpool, UKDepartment of Surgery and Cancer, Imperial College London, London, UKVascular Surgery, Liverpool University Hospitals NHS Foundation Trust, Liverpool, UKVascular Surgery, Liverpool University Hospitals NHS Foundation Trust, Liverpool, UKSchool of Medicine, University of Liverpool, Liverpool, UKVascular Surgery, North Bristol NHS Trust, Bristol, UKVascular Surgery, North Bristol NHS Trust, Bristol, UKVascular Surgery, Liverpool University Hospitals NHS Foundation Trust, Liverpool, UKRadiology, Liverpool University Hospitals NHS Foundation Trust, Liverpool, UKVascular Surgery, Ninewells Hospital, Dundee, UKLiverpool Clinical Trials Centre, University of Liverpool, Liverpool, UKVascular Surgery, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UKVascular Surgery, St Georges University Hospitals NHS Foundation Trust, London, UKVascular Surgery, University Hospital Southampton NHS Foundation Trust, Southampton, UKInterventional Radiology, Leeds Teaching Hospitals NHS Trust, Leeds, UKLiverpool Clinical Trials Centre, University of Liverpool, Liverpool, UKLiverpool Clinical Trials Centre, University of Liverpool, Liverpool, UKRadiology, Liverpool University Hospitals NHS Foundation Trust, Liverpool, UKVascular Surgery, Manchester University NHS Foundation Trust, Manchester, UKVascular Surgery, Lancashire Teaching Hospitals NHS Foundation Trust, Preston, UKLiverpool Clinical Trials Centre, University of Liverpool, Liverpool, UKIntroduction 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.https://bmjopen.bmj.com/content/11/11/e054493.full |
| spellingShingle | Rui V Duarte Carrol Gamble Claire Taylor Bruce Campbell Jonathan R Boyle Andrew Cook Srinivasa Rao Vallabhaneni Colin D Bicknell Shaneel R Patel David C Ormesher Samuel R Smith Kitty H F Wong Paul Bevis John A Brennan Alastair P Crosher Murray M Flett Richard J Jackson Maciej T Juszczak Ian M Loftus Ian M Nordon Jai V Patel Kellie Platt Eftychia-Eirini Psarelli Peter C Rowlands John V Smyth Theodoros Spachos Leigh Taggart 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 BMJ Open |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/11/11/e054493.full |
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