Abdominal Aortic Aneurysm Without Rupture
Conditions
Keywords
Abdominal aortic aneurysm, Day case, Endovascular aneurysm repair, Short stay
Brief 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.
Detailed description
The STAR study is a prospective multicentre observational cohort study to assess the eligibility, uptake, viability, acceptability, safety, and cost of a short stay (23-hour) aneurysm pathway for infrarenal AAA patients. The study will take place at least at five sites in the United Kingdom. Over a 12-month recruitment period, all patients with AAA referred to or diagnosed at each of the units will be assessed for inclusion in the STAR pathway if suitable for EVAR. The study anticipates the assessment of over 200 AAA patients with the aim of recruiting up to 100 patients into the study to undergo EVAR using the STAR pathway. Patients may be enrolled into the study to undergo EVAR using the STAR pathway provided all inclusion and no exclusion criteria are met. Subjects will be evaluated through to hospital discharge, receive a telephone call at 48 hours, return for follow-up visits at one month, and telephone follow-ups at three- and six months post treatment. Patients recruited into the study will have their routine clinical data collected at 12 months when they return for follow-up visits.
Interventions
None listed
Sponsors
W.L.Gore & Associates
Medtronic
Imperial College London
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
Yes
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 available in the home environment (e.g., nebulisers or oxygen therapy which is not set up at home) * Any other condition, which in the opinion of the multidisciplinary team makes discharge within 23-hours unsafe * Patients who lack capacity to consent to 23-hour EVAR will be excluded from the study * There is concurrent enrolment in another drug or medical device study or have recently been involved in any research prior to recruitment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Costs up to 6 months | 18 months | Inpatient micro-costing, surveys, as well as health resource use after discharged will be measured as any increase in social care and/or informal care |
| Quality of life measure | 18 months | EQ-5D-5L health status questionnaires will be administered at baseline, 3- and 6-months post-op |
| Safety: Adverse events, readmissions and mortality | 24 months | Rate of device-related and other adverse events, readmission, mortality (at 30, 90 days and 6- and 12- months) of patients |
| Eligibility | 12 months | Proportion of patients suitable for a short stay pathway (assessed in 200 patients) |
| Uptake | 12 months | Proportion of patients who will accept admission to this pathway (assessed in all eligible patients) |
| Viability | 12 months | Proportion of patients admitted to the short-stay pathway that can be discharged at 23-hours |
| Treatment satisfaction | 18 months | Treatment satisfaction will be measured using the validated Aneurysm TSQ questionnaire |
| Patient well-being and stress | 18 months | Well-being (W-B16) questionnaires will be used to measure depressed and anxious mood, energy, positive well-being, and stress at baseline, at 2-4 days and 30 days post-op |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Creation of a 'STAR tool-kit' | 12 months | This may be used for implementation of a short-stay pathway in a wider group, to ensure sustainability. The toolkit will be produced if there are a significant proportion eligible and accepting the pathway and the pathway is viable without perceived safety issues |
| Qualitative data | 12 months | Describing the experiences, worries and concerns of patients, families and GPs as well as staff involved in the implementation of STAR, thus identifying the key barriers and drivers to implementation of a 23-hour pathway |
Countries
United Kingdom
Contacts
Primary ContactColin Bicknell
Backup ContactMaria Nicola
Outcome results
None listed