Caprini Score in Venous Surgery: a Prospective Cohort Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2027-01-01

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Venous Thromboembolism Varicose Veins

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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EVLT

Endovenous laser treatment of great saphenous vein, small saphenous vein, accessorial saphenous vein with different laser wavelength and any bare type

Intervention Type PROCEDURE

RFA

Radiofrequency ablation of great saphenous vein, small saphenous vein, accessorial saphenous vein with ClosureFast technique

Intervention Type PROCEDURE

USFS

Ultrasound guided foam sclerotherapy of great saphenous vein, small saphenous vein, accessorial saphenous vein with polidocanol or tetradecyl sulphate of any concentration

Intervention Type PROCEDURE

HL/stripping

High ligation and stripping of great saphenous vein, small saphenous vein, accessorial saphenous vein

Intervention Type PROCEDURE

Miniphlebectomy

Miniphlebectomy of any varicose veins under local, regional or general anaesthesia

Intervention Type PROCEDURE

Sclerotherapy

Foam or liquid sclerotherapy of any varicose veins with polidocanol or tetradecyl sulphate of any concentration

Intervention Type PROCEDURE

GCS

Graduated compression stockings may be used after procedure by the decision of the doctor

Intervention Type DEVICE

LMWH

Low-molecular-weight heparin may be used after procedure by the decision of the doctor

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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