Cost-utility Analysis of the Outpatient Versus Conventional Hospitalization in Treatment of Occlusive Arterial Disease (AMBUVASC)

Nantes University Hospital (NUH)

Status: Completed

Conditions: Peripheral Arterial Disease

Treatments: Procedure: Treatment of Occlusive Arterial Disease

Study type: Interventional

Funder types: Other

Identifiers

NCT02581150

PRME-14-0444 (Other Grant/Funding Number)

RC15_0044

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Outpatient hospitalisation

Other group

Description:

The intervention is the Treatment of Occlusive Arterial Disease, during an ambulatory hospitalisation, with the use of an arterial closure device (ACD). The patients treated for PAD (Peripheral Arterial Disease) are informed and prepared in the morning of D0. The surgical endovascular procedure is performed at D0 before 1:00 p.m. The patients leave the hospital in the evening at D0 after a systematic visit.

Treatment:

Procedure: Treatment of Occlusive Arterial Disease

Conventional inpatient hospitalisation

Other group

Description:

The intervention is the Treatment of Occlusive Arterial Disease, during a conventional hospitalisation, with or without ACD (ACD will be used at the discretion of the interventionalist). The patients treated for PAD arrive at the hospital the day before surgery (D-1). The surgical endovascular procedure takes place the next day (D0). The day after (D1), the patients leave the hospital after a systematic visit.

Treatment:

Procedure: Treatment of Occlusive Arterial Disease