An observational study in Abdominal Aortic Aneurysm, Stress and Surgery, sponsored by Imperial College London. Status unknown at 1 site in United Kingdom. Open to participants aged 50 Years to 100 Years. Per ClinicalTrials.gov, last updated 2022-02-08.
Sponsored by Imperial College London · Observational
It is recognised that women are at greater risk of death, complications and longer hospital stay following intact abdominal aortic aneurysm (AAA) repair, and the reason for this is not yet established. This disparity in outcomes for women compared to men is also recognised in other forms of cardiovascular surgery, which raises the question of whether women and men are reacting differently to the stress of operative repair.
This study aims to examine whether there are differences baseline stress markers and in the stress response to AAA repair between men and women. It will also examine whether markers of stress are associated with poor clinical outcomes and slower recovery (indicated by longer hospital stay).
The study will take the form of an observational cohort study. It will not alter any of the treatment that men and women receive, but will monitor their stress levels using physiological markers (through ECG (electrocardiogram) monitoring using a non-invasive holter, biochemical markers using blood samples (which will be taken at the same time as routine testing, so as not to require further invasive procedures), and psychological testing, using short forms that the patient will be able to fill out independently at different stages of their recovery. Clinical data will be used to look for relevant factors (clinical history or medications) which may alter the stress markers we are observing, and to compare outcomes with markers of stress.
Patients will be asked for their consent to share their data with the research team in order to participate in the study. It will be made clear that there will be no change in their clinical or operative management if they participate in the study and they will be able to withdraw consent for further participation at any time.
960 studies on the registry are indexed under Aneurysm; 175 are open to participants now.
This study's planned enrollment of 60 is below the median of 151 across 443 observational studies indexed under Aneurysm.
Browse Aneurysm studies →Imperial College London is the lead sponsor of 824 studies on the registry; 178 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Men and women undergoing primary elective intact AAA repair, open or endovascular (EVAR) at participating centres.
Consecutive recruitment.
Exclusion Criteria:
Elective AAA Repair
Other: Elective AAA Repair
Elective AAA Repair
Other: Elective AAA Repair
Elective AAA Repair - Observation of Stress Response
Biochemical measures of stress: level of serum cortisol & dehydroepiandrosterone (DHEA)
Sex-specific differences in baseline and timing/magnitude of response to operative stress.
Time frame: Samples taken on the morning of operation (baseline), at anaesthetic induction, at the end of the procedure, 6 hours post-procedure and early morning samples during the remaining inpatient stay.
Physiological parameters: assessment of beat-to-beat heart rate variability metrics.
Sex-specific differences in baseline and timing/magnitude of response to operative stress.
Time frame: Baseline recording compared to post-operative recording of patient recovery during inpatient stay.
Psychological measures of stress: measured by State Trait Anxiety Inventory-Y and self assessment (Likert Scale).
Sex-specific differences in the baseline and timing/magnitude of response to operative stress.
Time frame: Pre-operative assessment compared to post-operative assessment at specified intervals during operative recovery - 2, 14, 30 and 90 days post-operation.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Imperial College London