ShorT Stay Aneurysm Repair (STAR): A 23-hour Endovascular Abdominal Aortic Aneurysm Repair Pathway With Evaluation of Eligibility, Uptake, Viability, Acceptability, Safety and Cost
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Treatment satisfaction
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Treatment satisfaction
时间窗: 18 months
Treatment satisfaction will be measured using the validated Aneurysm TSQ questionnaire
Eligibility
时间窗: 12 months
Proportion of patients suitable for a short stay pathway (assessed in 200 patients)
Uptake
时间窗: 12 months
Proportion of patients who will accept admission to this pathway (assessed in all eligible patients)
Patient well-being and stress
时间窗: 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
Quality of life measure
时间窗: 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
时间窗: 24 months
Rate of device-related and other adverse events, readmission, mortality (at 30, 90 days and 6- and 12- months) of patients
Costs up to 6 months
时间窗: 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
Viability
时间窗: 12 months
Proportion of patients admitted to the short-stay pathway that can be discharged at 23-hours
次要结局
- Qualitative data(12 months)
- Creation of a 'STAR tool-kit'(12 months)