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The aim of the study is to make a validation of Caprini score in patients undergoing varicose veins surgery, especially endovascular procedures (endovascular laser treatment - EVLT, radiofrequency ablation - RFA, ultrasound-guided foam sclerotherapy - USFS) and to identify patients with elevated risk of postoperative venous thromboembolism (VTE) who will benefit from prophylactic anticoagulation.
A prospective cohort study based on the platform of Ongoing Registry of Treatment of Chronic Venous Diseases (NCT03035747). The study will enrol adult patients undergoing any kind of varicose veins surgery with and without any prophylaxis. The patients should be examined for venous thromboembolic complications during 2-4 weeks after the procedure with mandatory duplex ultrasound.
The study will provide following information:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EVLT | Procedure | Endovenous laser treatment of great saphenous vein, small saphenous vein, accessorial saphenous vein with different laser wavelength and any bare type | ||
| RFA | Procedure | Radiofrequency ablation of great saphenous vein, small saphenous vein, accessorial saphenous vein with ClosureFast technique | ||
| USFS | Procedure | Ultrasound guided foam sclerotherapy of great saphenous vein, small saphenous vein, accessorial saphenous vein with polidocanol or tetradecyl sulphate of any concentration | ||
| HL/stripping | Procedure | High ligation and stripping of great saphenous vein, small saphenous vein, accessorial saphenous vein | ||
| Miniphlebectomy | Procedure | Miniphlebectomy of any varicose veins under local, regional or general anaesthesia |
| Measure | Description | Time Frame |
|---|---|---|
| any episode of VTE | symptomatic or asymptomatic, confirmed by instrumental diagnostics | 0-4 weeks after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| symptomatic deep vein thrombosis | symptomatic deep vein thrombosis confirmed by duplex ultrasound | 0-4 weeks after procedure |
| symptomatic pulmonary embolism | symptomatic pulmonary embolism confirmed by perfusion isotope scanning or CT pulmonary angiography |
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Inclusion Criteria:
Exclusion Criteria:
- lost for follow-up during 4 weeks
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Any patient with varicose veins that undergoing any kind of varicose vein surgery.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kirill Lobastov, PhD | Contact | +7-985-211-63-31 | lobastov_kv@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Kirill Lobastov, PhD | Pirogov Russian National Research Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pirogov Russian National Research Medical University | Recruiting | Moscow | 117997 | Russia |
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| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| D014648 | Varicose Veins |
| D020246 | Venous Thrombosis |
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D015911 | Sclerotherapy |
| D006495 | Heparin, Low-Molecular-Weight |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
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| Sclerotherapy | Procedure | Foam or liquid sclerotherapy of any varicose veins with polidocanol or tetradecyl sulphate of any concentration |
| GCS | Device | Graduated compression stockings may be used after procedure by the decision of the doctor |
| LMWH | Drug | Low-molecular-weight heparin may be used after procedure by the decision of the doctor |
| 0-4 weeks after procedure |
| asymtomatic deep vein thrombosis | asymptomatic DVT revealed by duplex ultrasound | 2-4 weeks after procedure |
| endovenous thermal-induced thrombosis | EHIT revealed by duplex ultrasound | 0-4 weeks after procedure |
| major bleeding | Fatal bleeding, and/or symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, and/or bleeding causing a fall in haemoglobin level of 20 g/L or more, or leading to transfusion of two or more units of whole blood or red cells. | 0-4 weeks after procedure |
| clinicaly relevant bleeding | any non-major bleeding need for treatment or intervention | 0-4 weeks after procedure |
| death for any reason | 0-4 weeks after procedure |
| D013927 |
| Thrombosis |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D011134 |
| Polysaccharides |
| D002241 | Carbohydrates |