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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2017-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Peripheral Arterial Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Outpatient hospitalisation

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.

Group Type OTHER

Treatment of Occlusive Arterial Disease

Intervention Type PROCEDURE

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.

Conventional inpatient hospitalisation

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.

Group Type OTHER

Treatment of Occlusive Arterial Disease

Intervention Type PROCEDURE

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.

Interventions

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Treatment 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No