About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
age over 18 years
any kind of varicose vein surgery
follow up for 4 weeks after the procedure
examination for VTE at 2-4 weeks after the procedure, including duplex ultrasound
Disqualifiers
None
Trial population
Any patient with varicose veins that undergoing any kind of varicose vein surgery.
Trial design
Cohort
Prospective
Treatments tested in this trial
EVLT
Procedure/SurgeryEndovenous laser treatment of great saphenous vein, small saphenous vein, accessorial saphenous vein with different laser wavelength and any bare type
RFA
Procedure/SurgeryRadiofrequency ablation of great saphenous vein, small saphenous vein, accessorial saphenous vein with ClosureFast technique
USFS
Procedure/SurgeryUltrasound guided foam sclerotherapy of great saphenous vein, small saphenous vein, accessorial saphenous vein with polidocanol or tetradecyl sulphate of any concentration
HL/stripping
Procedure/SurgeryHigh ligation and stripping of great saphenous vein, small saphenous vein, accessorial saphenous vein
Miniphlebectomy
Procedure/SurgeryMiniphlebectomy of any varicose veins under local, regional or general anaesthesia
Sclerotherapy
Procedure/SurgeryFoam or liquid sclerotherapy of any varicose veins with polidocanol or tetradecyl sulphate of any concentration
GCS
DeviceGraduated compression stockings may be used after procedure by the decision of the doctor
LMWH
DrugLow-molecular-weight heparin may be used after procedure by the decision of the doctor
Treatment groups
Trial outcomes
Primary outcomes
any episode of VTE
symptomatic or asymptomatic, confirmed by instrumental diagnostics
Secondary outcomes
symptomatic deep vein thrombosis
symptomatic deep vein thrombosis confirmed by duplex ultrasound
symptomatic pulmonary embolism
symptomatic pulmonary embolism confirmed by perfusion isotope scanning or CT pulmonary angiography
asymtomatic deep vein thrombosis
asymptomatic DVT revealed by duplex ultrasound
endovenous thermal-induced thrombosis
EHIT revealed by duplex ultrasound
Sponsors and contacts
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