Peripheral Arterial Disease
Conditions
Keywords
Outpatient hospitalization, Randomized trial, Peripheral arterial disease, Endovascular treatment, Health Economics
Brief summary
The purpose of this study is to assess the efficiency of outpatient surgery compared to conventional hospitalization in endovascular treatment of occlusive arterial disease. A cost-utility analysis will be conducted from a societal perspective. Patients referred for peripheral arterial disease (PAD) will be randomized in two arms and a 3 months follow-up will be performed.
Detailed description
Rationale for ambulatory hospitalization is based on increased demand of hospital care, hospital budgets constraints and patients who ask for a prompt recovery. Consequently, physicians should find ways to optimize the resources' allocation, without compromising quality, safety and efficiency of patient care. Several studies and routine practice have shown that ambulatory hospitalization was safe but we are still lacking evidence to demonstrate the cost-utility of this kind of management.
Interventions
PROCEDURETreatment of Occlusive Arterial Disease
Regarding the intervention, the technique used during the diagnostic and/or therapeutic procedure shall be left to the operator's discretion, except the use of an arterial closure device (ACD). In the ambulatory hospitalisation arm, the ACD use will be mandatory. In the conventional hospitalisation arm, ACD will be used at the discretion of the interventionalist.
Sponsors
Nantes University Hospital
Ministry of Health, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Patients limping * Patients with PAD requiring endovascular management * Patients with stabilized level 1 to 3 ASA (classification of the American Society of Anesthesiology) * Ability to walking * Endovascular indicated and compatible with an introducer 5F to 7F * Agreeing to participate in the study and having signed an informed consent. * Agreeing to lend itself to a post-operative monitoring a duration of 30 days * Social Insured
Exclusion criteria
* No possibility of an outpatient management * Previous participation in the AMBUVASC study * Refusal of patient to participate in the study * Patient with hemostasis disorders * Acute Ischemia * Using a more 7F introducer * Radial or brachial puncture * Antegrade femoral puncture * Contraindication to endovascular treatment * Less than one month life expectancy * Participation in another clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incremental Cost Effectiveness Ratio (ICER) comparing cost and utility in the two arms | 3 months | The objective of the study is to perform a cost-utility analysis comparing outpatient surgery to conventional hospitalization in endovascular treatment of occlusive arterial disease. The analysis will be conducted from a society's perspective using a one-month time horizon following the date of intervention (and 2 months before intervention). A microcosting approach will be used to estimate the cost of the surgical intervention in both arms and all subsequent in-hospital and ambulatory care resources consumption will be systematically recorded during the one month follow-up period. Effectiveness will be assessed in terms of Quality-Adjusted Life-Years (QALYs) estimated from patients' answers to the Euroqol EQ-5D questionnaire and french preferences scores. Results will be presented as an incremental cost-per-QALY ratio. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Budget impact analysis | 5 years | The budget impact analysis will estimate the net financial profit (the difference between the costs incurred and profits obtained, or avoided costs) in developing the ambulatory surgery in the management of PAD. The perspective adopted will be that of the health care facilities and of the National health insurance. This analysis will be conducted in a 5 years time horizon to consider a full exploitation of the potential for substitution between conventional hospitalisation and ambulatory hospitalisation for eligible patients. |
| Complication rates | 1 month | The major vascular complications that can occur within 30 days are: Complications Intraoperative, Hematoma, Bleeding from the groin, arteriovenous fistula, Pseudo aneurysm, retroperitoneal hemorrhage, Critical Ischemia, Infection, Thrombosis. |
| Functional improvement | 1 month | The assessment of the functional improvement will be performed with Rutherford Classification. |
| Time period to back-to-work | 1 month | The time period to back-to-work will be assessed through the measurement of the duration of sick leave for people who work. |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORYann Gouëffic, Md., PhD.
University Hospital of Nantes, France
Outcome results
None listed