Venous Insufficiency
Conditions
Interventions
This is a randomized clinical study with three arms, open-label, conducted at a single center. Participants will be equally treated with the gold standard technique for correcting insufficiency and di
conventional surgical removal
or sclerotherapy with dense polidocanol foam, with individuals in this group randomized for simultaneous treatment or treatment at a later time, six weeks after the main intervention
Sponsors
Hospital Universitário Pedro Ernesto da Universidade do Estado do Rio de Janeiro
Hospital Universitário Pedro Ernesto da Universidade do Estado do Rio de Janeiro
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age greater than or equal to 18 years; no upper age limit; patients of both sexes; surgical risk classified by the American Society of Anesthesiologists as I to III; clinical presentation of itching, pain, tightness, skin irritation, heaviness, cramps, or other symptoms secondary to chronic venous disease congestion; presence of tributary varicose veins with reflux, enlarged with a diameter equal to or greater than 3 millimeters and tortuous; Doppler ultrasound of the great saphenous vein showing venous reflux greater than 0.5 seconds in the standing position after manual compression maneuver of the calf upstream; diameter equal to or greater than six millimeters in cross-section in the thigh, 15 cm below the saphenofemoral junction; clinical classification 2 to 6; agreement with the proposed protocol and signing of the consent form
Exclusion criteria
Exclusion criteria: Pregnancy or breastfeeding; severe systemic disease, ongoing neoplasia, or without oncological criteria for cure; prolonged restriction of mobility; history of or current manifestation of thrombophilia, deep vein thrombosis, or pulmonary embolism based on history, physical examination, or complementary methods; absence of the posterior tibial and dorsalis pedis pulses, with an ankle brachial index of less than 0.9; prior surgical treatment for the cure of varicose veins, whether conventional surgery or endovenous ablation, that included access to the saphenous vein in the thigh; ultrasound of the candidate axial vein for intervention showing aplasia, hypoplasia, occlusion, or segmental tortuosity that precludes the progression of the endolaser fiber
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In the primary efficacy outcome, the goal is to evaluate the occlusion rate of the studied vessel after 30 days and after one year post-intervention. The occurrence of this effect will be verified through vascular ultrasound and may be classified as complete occlusion, complete luminal obliteration, or absence of the treated segment upon USD examination, confirmed by the analytical mode of power Doppler; partial recanalization will be defined when the sum of recanalized segments by ultrasound extends between 0 and 10 cm and there is reflux greater than 0.5 seconds in the standing position; and treatment failure will be defined when the sum of recanalized segments exceeds 10 cm and reflux is maintained at greater than 0.5 seconds in the standing position. If there is a presence of a recanalized segment but reflux disappears, the result will be considered as restoration of venous flow. In all cases where occlusion is not observed, the diameters of the anatomical reference points will be analyzed in the follow-up. Raw data will be tabulated and statistically compared to assess whether the outcome occurred | — |
Secondary
| Measure | Time frame |
|---|---|
| In the secondary safety outcome, the objective is to assess the proportion of participants with the manifestation of anticipated adverse events according to the type of treatment employed in the first 30 days of treatment. These will be verified through direct observation or reported by the participant and tabulated for frequency calculation. Anticipated adverse events considered will include thrombophlebitis, spontaneous or outpatient drainage of a clot, pain, bruising or hematoma, hyperpigmentation, residual varicose veins, recurrent varicose veins, among other events of similar intensity. The incidence of adverse events will be compared among the techniques used, based on the transverse diameters of the treated veins, by quartiles, and the duration of persistence during follow-up. In the secondary efficacy outcome, the aim is to evaluate the occlusion rate of the studied veins up to five years after the intervention; the impact of different interventions on the evolution of primary clinical scores up to five years after the intervention, with scores considered including the clinical classification of varicose veins, the visual analog scale, and the venous clinical severity score and Aberdeen varicose vein questionnaire, analyzing the level obtained before the intervention and throughout the five years of follow-up | — |
Countries
Brazil
Contacts
Public ContactDouglas Figueiredo
Hospital Universitário Pedro Ernesto
Outcome results
None listed