ShorT Stay Aneurysm Repair Study (NCT05279274) | Clinical Trial Compass
UnknownNot Applicable
ShorT Stay Aneurysm Repair Study
United Kingdom100 participantsStarted 2022-11-01
Plain-language summary
A prospective observational cohort study to assess the eligibility, uptake, viability, acceptability, safety, and cost of a ShorT stay (23-hour) Aneurysm Repair (STAR) pathway. Outcomes will be collected for up to 1 year.
Who can participate
Age range55 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* They have been assessed as suitable for standard infrarenal EVAR within the manufacturer's "Instructions for Use" for the chosen endograft.
* Age over 55 (effectively excluding connective tissue disease)
* Fully independent at home or adequate provision for home care after discharge which would enable patients to perform basic activities of daily living including mobility, eating, drinking, and bathing
* Living with a partner or family member or having similar help available for the first 24-hours after discharge from the hospital
* Transport to attend the hospital in which they were treated within 1 hour for the first 24-hours after discharge. Should an ambulance not be readily available to attend the hospital within this timeframe, patients must be made aware and agree to make their own transport arrangements.
* Capable of complying with Protocol requirements, including follow-up
* An Informed Consent Form signed by the participant or legal representative
Exclusion Criteria:
* Significant cardiac disease, defined as one or more major predictors of increased perioperative cardiovascular risk according to the American College of Cardiology Cardiac Risk Classification, which remains untreated at the time of surgery
* Significant renal failure (pre-operative creatinine level of over 150 μmol/L or GFR less than 30mL/min/1.73m2 indicating severe chronic kidney disease (stage IV)
* Significant respiratory disease needing increased post-operative care not a…
What they're measuring
1
Eligibility
Timeframe: 12 months
2
Uptake
Timeframe: 12 months
3
Viability
Timeframe: 12 months
4
Treatment satisfaction
Timeframe: 18 months
5
Patient well-being and stress
Timeframe: 18 months
6
Quality of life measure
Timeframe: 18 months
7
Safety: Adverse events, readmissions and mortality