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Numerous studies have demonstrated excellent diagnostic accuracy of Compression Ultrasonography (CUS) performed by hospitals doctors, skilled and unskilled in Radiology.
Recently, it was demonstrated that adequately ultrasonography-trained General Practitioners (GP) can perform reliable ultrasound to increase the speed and improve the quality of clinical management of various clinical conditions. To date, in the medical literature there are no studies that demonstrate the diagnostic accuracy of GP in performing CUS for the diagnosis of Deep Vein Thrombosis (DVT). Therefore, we plan to perform a prospective, multicenter, cohort study in which a large number of consecutive outpatients with symptoms or signs of DVT are subject to the CUS by the GP with the aim of evaluating the precision and the diagnostic accuracy compared to specialists in vascular ultrasound, which in this case will be the standard of reference.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| first episode of suspected DVT of the lower limbs | patients with first suspected episode of DVT of the lower limbs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| compression ultrasonography | Other | CUS in patients with a high pre-test clinical probability of DVT and/or a positive D-dimer |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic accuracy of General Practitioner in performing CUS for the diagnosis of DVT | Aim of our study is to perform a prospective, multicenter, cohort study in which a large number of consecutive outpatients with symptoms or signs of DVT are subject to the CUS by the General Practitioner with the aim of evaluating the diagnostic accuracy. | Up to 2 h hours after ambulatory admission |
| Measure | Description | Time Frame |
|---|---|---|
| Precision of CUS performed by General Practitioner for the diagnosis of DVT | The secondary outcome of the study will be the the precision of CUS performed by a doctor of general medicine for the diagnosis of proximal DVT of the lower limbs with respect to the medical specialist in vascular diagnostics, in this case used as a reference. | Up to 2 h hours after ambulatory admission |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the prevalence of DVT in patients with a high pre-test probability and/or a positive D-dimer | Up to 2 h hours after ambulatory admission |
Inclusion Criteria:
Exclusion Criteria:
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All outpatients evaluated at home or at office by the GP with a first episode of suspected DVT of the lower limbs will be screened with CUS. GP may use his/her own ultrasound, or take advantage of the equipment of the Vascular Service of the Hospital. Shortly afterward, (i.e., within 2 hours), all outpatients will be re-evaluated by a doctor with expertize in vascular ultrasound
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| Name | Affiliation | Role |
|---|---|---|
| Nicola Mumoli, MD | Section of Vascular Medicine - Livorno Hospital, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda USL 6 Livorno | Livorno | Tuscany | 57100 | Italy |
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| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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d-dimer