Juxtarenal aortic aneurysms Circulatory System Juxtarenal aortic aneurysms
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time 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
| Measure | Time 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