varicose veins
Conditions
Interventions
This is a prospective, single-center clinical study focused on two parallel groups.
Experimental group: 60 lower limbs with clinical indication for interventional treatment of the great saphenous vein
E04.014.760
Sponsors
Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Eligibility
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Symptomatic lower limb varicose veins; age over 18 and under 80; presence of total or partial reflux of the great saphenous vein of one or both or limbs, detected on duplex ultrasound with indication for surgical treatment
Exclusion criteria
Exclusion criteria: Significant underlying diseases in activity such as cancer, lupus, tuberculosis; infectious disease (infected ulcers); history of clotting disorders (thrombophilia); history of thromboembolic events (deep vein thrombosis); use of anticoagulant or antiplatelet medication; pregnancy; high cardiovascular risk
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected Primary Outcome 1 An analysis of the change in quality of life, as measured by the application of pre-operative and 30-day post-operative quality of life questionnaires, is expected to demonstrate a more favorable change in the radiofrequency ablation group compared to the saphenectomy group across all studied questionnaires. An improvement in the quality of life score exceeding 8 points in the quality of life questionnaires is anticipated.;Primary Outcome 1 Findings Analysis of the change in quality of life, as measured by pre-operative and 30-day post-operative quality of life questionnaires, revealed a more favorable change for the radiofrequency ablation group compared to the saphenectomy group across all questionnaires studied. However, the magnitude of the improvement in quality of life was 2,8 points on the AVVQ questionnaire and 6,7 points on the CIVIQ questionnaire, values which were not statistically significant.;Expected Primary Outcome 2 To compare the cost-effectiveness — assessed via the cost-effectiveness ratio (CER) and the incremental cost-effectiveness ratio (ICER) — of saphenectomy and radiofrequency ablation. The direct cost of the procedures will be used as the cost input, while the change in quality of life, as measured by the Chronic Venous Insufficiency Questionnaire (CIVIQ) and the Aberdeen Varicose Vein Questionnaire (AVVQ), will serve as the measure of effect. It is anticipated that both the CER and ICER will indicate the superior cost-effectiveness of radiofrequency ablation compared to saphenectomy.;Primary Outcome 2 Findings The cost-effectiveness of saphenectomy and radiofrequency ablation was compared using the cost-effectiveness ratio (CER) and incremental cost-effectiveness ratio (ICER). The analysis utilized the direct cost of procedures as the cost measure and the change in quality of life scores from both the Chronic Venous Insufficiency Questionnaire (CIVIQ) and Aberdeen Varicose Vein Questionnaire (AVVQ) as the | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected Secondary Outcome 1 Upon analyzing the treatment efficacy for the great saphenous vein using both techniques, as assessed by Doppler ultrasonography, an equivalent level of efficacy is expected between the two groups.;Secondary Outcome 1 Findings Analysis of treatment efficacy for the great saphenous vein using both techniques, as assessed by Doppler ultrasound, revealed an equivalent success rate between the two groups. Surgical saphenectomy demonstrated a 100% success rate, while radiofrequency ablation showed a 96.6% success rate.;Expected Secondary Outcome 2 Analysis of the direct costs of the procedures and their early complications – using microcosting and macro-costing techniques with data from the cost center of the Hospital Estadual de Américo Brasiliense – is expected to demonstrate higher direct costs for radiofrequency ablation compared to saphenectomy.;Secondary Outcome 2 Findings An analysis of the direct costs of the procedures and their early complications—using microcosting and macro-costing techniques with data from the cost center of the Hospital Estadual de Américo Brasiliense—revealed that the direct cost of radiofrequency ablation was 64% higher than that of saphenectomy. | — |
Countries
Brazil
Contacts
Public ContactGuilherme Garcia
Faculdade de Medicina de Ribeirão Preto da USP
Outcome results
None listed