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In Westernized countries, the prevalence of peripheral arterial disease (PAD) is estimated at 15-20% of subjects over 70 years of age and is increasing considerably because of the aging of the population and the increasing prevalence of diabetes and renal insufficiency. In response to this increase in incidence, vascular surgeons must develop innovative treatments that minimize the use of resources in a context of budgetary constraints, in patients who are increasingly well informed, while maintaining the safety and effectiveness of the procedures performed.
The endovascular technique has several advantages. First, it is a minimally invasive treatment, most often performed under local anesthesia. Secondly, the duration of the procedure and the length of hospitalization are reduced. In addition, the peri-operative morbidity and mortality is extremely low.
In France, for many years, public health policies have encouraged the development of outpatient hospitalization. Endovascular treatment allows the development of outpatient care. The French Society of Vascular and Endovascular Surgery (SCVE) was the first European society to publish recommendations concerning the outpatient management of endovascular treatment of PAD. These recommendations aim to promote the development of outpatient treatment by providing a framework for practitioners wishing to offer this type of management.
Concerning the patient and according to the SCVE recommendations, all types of occlusive arterial lesions of the lower limbs can be managed on an outpatient basis and only patients with severe comorbidities are excluded from this type of hospitalization. In addition, various studies have shown the safety of outpatient hospitalization for PAD. The absence of an accompanying person on the night following the procedure is considered an exclusion criterion for outpatient care.
The objective of this Stepped-wedge Cluster Randomized Controlled Trial is to increase the use of outpatient hospitalization for endovascular treatment of PAD by proposing a care pathway adapted to people without an accompanying person on the night of the procedure at home.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Group1 | Experimental | In group 1: 5 centers will be randomized for the inclusion of unaccompanied patients for 24 months |
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| Experimental: Group2 | Experimental | In group 2: 5 other centers will be randomized for the inclusion of unaccompanied patients for 18 months |
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| Experimental: Group3 | Experimental | In group 3: 5 other centers will be randomized for the inclusion of unaccompanied patients for 12 months |
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| Experimental: Group4 | Experimental | In group 4: 5 other centers will be randomized for the inclusion of unaccompanied patients for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 24 months of inclusion of unaccompanied patients | Other | inclusion for 6 months of accompanied patients in conventional outpatient care (observational period) and then inclusion for 24 months of unaccompanied with remonte surveillance patients and accompanied patients (interventional period) |
| Measure | Description | Time Frame |
|---|---|---|
| Outpatient Hospitalization Rate for Endovascular Treatment of PAD at the End of the Procedure Period | 30 month |
| Measure | Description | Time Frame |
|---|---|---|
| Number of postoperative complications requiring re-hospitalization | 1 month | |
| Functional improvement at 1 month as assessed by the Rutherford classification | 1 month | |
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Inclusion Criteria:
For accompanied patients only:
- Patient does not object to the processing of his or her data
Only for isolated patients:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yann GOUEFFIC | Contact | +33 (0)1 44 12 75 91 | ygoueffic@ghpsj.fr | |
| Florence LECERF | Contact | +33 (0) 1 40 94 25 17 | f.lecerf@ghpsj.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Jean Minjoz | Recruiting | Besançon | 25030 | France |
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standard care: accompanied patients Remote surveillance: unaccompanied patients
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|
| 18 months of inclusion of unaccompanied patients | Other | inclusion for 12 months of accompanied patients in conventional outpatient care (observational period) and then inclusion for 18 months of unaccompanied with remonte surveillance patients and accompanied patients (interventional period) |
|
| 12 months of inclusion of unaccompanied patients | Other | inclusion for 18 months of accompanied patients in conventional outpatient care (observational period) and then inclusion for 12 months of unaccompanied with remonte surveillance patients and accompanied patients (interventional period) |
|
| 6 months of inclusion of unaccompanied patients | Other | inclusion for 24 months of accompanied patients in conventional outpatient care (observational period) and then inclusion for 6 months of unaccompanied with remonte surveillance patients and accompanied patients (interventional period) |
|
| Assessment of patient anxiety using the HAS anxiety questionnaire |
| pre-procedure |
| Assessment of patient anxiety using the HAS anxiety questionnaire | immediately after procedure |
| Assessment of patient anxiety using the HAS anxiety questionnaire | Day 7 |
| Centre Hospitalier de Béziers, | Recruiting | Béziers | 34500 | France |
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| Hopital Universitaire Ambroise Paré, | Recruiting | Boulogne-Billancourt | 92100 | France |
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| CHRU Cavale Blanche | Recruiting | Brest | 29200 | France |
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| Chu Cote de Nacre | Recruiting | Caen | 14000 | France |
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| Hôpital Universitaire Gabriel Montpied | Recruiting | Clermont-Ferrand | 63003 | France |
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| Pôle médical du Grand large, | Recruiting | Décines-Charpieu | 69150 | France |
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| Hopital Le Bocage, | Recruiting | Dijon | 21000 | France |
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| Hopital Prive Dijon Bourgogne | Recruiting | Dijon | 21000 | France |
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| Clinique Mutualiste Porte de L'Orient | Recruiting | Lorient | 56324 | France |
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| Chu de Nantes | Recruiting | Nantes | 44000 | France |
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| Hopital Prive Du Confluent | Recruiting | Nantes | 44000 | France |
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| Chu de Nice, | Recruiting | Nice | 06000 | France |
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| Hôpital Saint Joseph | Recruiting | Paris | 75014 | France |
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| Polyclinique Francheville, | Recruiting | Périgueux | 24000 | France |
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| Clinique de L'Europe | Recruiting | Rouen | 76100 | France |
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| Centre Hospitalier Yves Le Foll- | Recruiting | Saint-Brieuc | 22027 | France |
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| Centre Hospitalier Privé SAINT GREGOIRE | Recruiting | Saint-Grégoire | 35760 | France |
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| Clinique Esquirol-Saint-Hilaire, | Recruiting | Saint-Hilaire | 47000 | France |
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| Médipôle Lyon Villeurbanne, | Recruiting | Villeurbanne | 69100 | France |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
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