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A comparison study of open surgery, minimal invasive surgery and medical management for complex aortic aneurysms

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN85731188
Enrollment
3100
Registered
2017-02-27
Start date
2017-07-01
Completion date
Unknown
Last updated
2026-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Juxtarenal aortic aneurysms Circulatory System Juxtarenal aortic aneurysms

Interventions

This is an observational study of patients being treated within the NHS for juxtarenal aortic aneurysms. No changes have been proposed in the care of patients for the purposes of this study and with t

Sponsors

The Royal Liverpool and Broadgreen University Hospials NHS Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients undergoing elective Juxtarenal AAA repair in England; juxtarenal AAA defined and stratified into 4 strata of anatomical complexity as specified in ‘Anatomical and Physiological Stratification’ 2. Patients with a Juxtarenal AAA 55 mm or larger in size and placed on Medical Management ‘Operation-deferred’

Exclusion criteria

Exclusion criteria: 1. Surgeon-modified stent-grafts and devices 2. Emergency operations (elective operations are distinguished from non-elective ones on NVR) 3. Thoracic or thorcaoabdominal aneurysms (this is a different extent/location of aneurysm disease, requiring different health technology. These treatments are currently being investigated by ETTAA study-HTA 11/147/03. Patients will be included in ETTAA), 4. Aneurysm neck anatomy suitable for standard infrarenal EVAR within IFU of any CE marked device 5. ‘Operation Declined Medical Management’ patients, due to co-morbidity or patient choice

Design outcomes

Primary

MeasureTime frame
Preoperative death, defined as a patient death by any cause occurring within 30 days of surgery, is measured by obtaining data on patients’ deaths from the office of national statistics (ONS) and relating any death date to the date of surgery to detainee if death occurred within 30 days.

Secondary

MeasureTime frame
1. Perioperative complications (morbidity) is measured using routinely collected data obtained through HES which will be collected annually throughout the course of the study 2. Long-term survival is measured using data on patient deaths obtained from the office of national statistics. 3. Secondary intervention in late follow-up is measured using obtained through HES which will be collected annually throughout the course of the study 4. Intensive care usage is measured using obtained through HES which will be collected annually throughout the course of the study 5. Length of hospital stay is measured using obtained through HES which will be collected annually throughout the course of the study 6. Treatment costs and health economic evaluations are completed using probabilistic modelling to generate estimates of the ICERs and compare the effect of the different structures of treatment provision on different sub-groups of patients 7. Quality of Life is measured using propectively collected EQ5D forms which will be measured at registration and every 3 months following in the subgroup of X patients who are registered into this cohort of the study

Countries

England, United Kingdom

Contacts

Public ContactCharlotte Rawcliffe
C.Rawcliffe@liverpool.ac.uk+44 1517 948167

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: May 16, 2026