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: * the rate of asymptomatic DVT after varicose veins surgery * the rate of symptomatic VTE after varicose veins surgery * the rate of thermal-induced thrombosis (EHIT) after endovenous thermal ablation * the ability of Caprini scores to predict VTE after varicose veins surgery * identification of patients with high risk of VTE who will benefit from prophylaxis, especially with anticoagulation
Study Type
OBSERVATIONAL
Enrollment
3,000
Endovenous laser treatment of great saphenous vein, small saphenous vein, accessorial saphenous vein with different laser wavelength and any bare type
Radiofrequency ablation of great saphenous vein, small saphenous vein, accessorial saphenous vein with ClosureFast technique
Ultrasound guided foam sclerotherapy of great saphenous vein, small saphenous vein, accessorial saphenous vein with polidocanol or tetradecyl sulphate of any concentration
Pirogov Russian National Research Medical University
Moscow, Russia
RECRUITINGany episode of VTE
symptomatic or asymptomatic, confirmed by instrumental diagnostics
Time frame: 0-4 weeks after procedure
symptomatic deep vein thrombosis
symptomatic deep vein thrombosis confirmed by duplex ultrasound
Time frame: 0-4 weeks after procedure
symptomatic pulmonary embolism
symptomatic pulmonary embolism confirmed by perfusion isotope scanning or CT pulmonary angiography
Time frame: 0-4 weeks after procedure
asymtomatic deep vein thrombosis
asymptomatic DVT revealed by duplex ultrasound
Time frame: 2-4 weeks after procedure
endovenous thermal-induced thrombosis
EHIT revealed by duplex ultrasound
Time frame: 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.
Time frame: 0-4 weeks after procedure
clinicaly relevant bleeding
any non-major bleeding need for treatment or intervention
Time frame: 0-4 weeks after procedure
death for any reason
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High ligation and stripping of great saphenous vein, small saphenous vein, accessorial saphenous vein
Miniphlebectomy of any varicose veins under local, regional or general anaesthesia
Foam or liquid sclerotherapy of any varicose veins with polidocanol or tetradecyl sulphate of any concentration
Graduated compression stockings may be used after procedure by the decision of the doctor
Low-molecular-weight heparin may be used after procedure by the decision of the doctor
Time frame: 0-4 weeks after procedure