Venous Insufficiency, Varicose veins of lower extremities
Conditions
Interventions
This is a randomized non-blinded clinical trial with two parallel groups with patients with varicose veins and great sahenous vein desease. A total of 40 pacients who meet the elegibility criteria wil
group 2 will be submitted to treatment of great saphenous vein reflux by endovenous laser thermoablation. Venous questionaries, clinical evaluation and ultrassound will be realized in pre-operatory, a
Sponsors
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
Hospital Estadual de Serrana
Eligibility
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Symptomatic lower limb varicose veins; Age greater than 18 years and less than 80 years; Presence of total or partial reflux of unilateral great saphenous vein that can be treated with both methods (stripping and endolaser), detected in 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 coagulation disorders (thrombophilia); History of thromboembolic events (deep vein thrombosis); Use of anticoagulant or antiplatelet medication; Pregnancy; High cardiovascular risk; Bilateral involvement of the great saphenous vein or concomitant involvement of the small saphenous vein;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1: Evaluete if there is a difference between the profile of biomarkers in patients undergoing saphenectomy conventional surgery and endolaser thermoablation;Expected outcome 2: It is expected to find a difference between the scores of the venous quality of life questionnaires of patients undergoing saphenectomy with conventional surgery and with endolaser thermoablation;Found outcome 1: In the endolaser group, there was an increase in inflammatory cytokines after 1 month, and after one week, there was a decrease in the dosage of IL-10, which has anti-inflammatory properties.;Found outcome 2: There was no difference in the scores between the groups, but in both groups there was a significant improvement in the venous quality of life questionnaires at 1 month compared to before the procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcome 3: It is expected that patients undergoing endolaser treatment will return to their work activities sooner.;Found outcome 3: Patients who underwent endolaser returned to their work activities 13 days before the conventional surgery group. | — |
Countries
Brazil
Contacts
Public ContactElisa Zampieri
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
Outcome results
None listed