Saphenous Vein, Varicose Veins of Lower Limb, Venous Insufficiency
Conditions
Brief summary
The goal of this clinical trial is to compare two surgical approaches for treating varicose veins in the lower limbs in adults: performing varicose vein removal at the same time as great saphenous vein stripping (concomitant) versus performing great saphenous vein treatment alone. The main questions it aims to answer are: * Do clinical outcomes differ between these approaches? * Does quality of life improve differently depending on which surgical approach is used? Participants will: * Undergo great saphenous vein stripping for lower limb varicose veins with or without simultaneous varicose vein ressection * Be assigned to have varicose vein resection either at the same time or in a subsequent procedure * Complete quality of life assessments before and after surgery
Interventions
PROCEDUREGreat saphenous vein stripping
Stripping of the great saphenous vein for the treatment of patients with chronic venous disease of the lower limbs associated with great saphenous vein insufficiency
PROCEDUREVaricose veins removal
Resection of visible varicose tributaries through staggered mini-incisions
Sponsors
Hospital Israelita Albert Einstein
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age between 18 and 70 years * Varicose veins of the lower limbs with great saphenous vein insufficiency and surgical indication (CEAP C2-C6) * Signed informed consent
Exclusion criteria
* Concomitant small saphenous vein insufficiency in the treated limb * Previous deep vein thrombosis in the treated limb * Previous deep venous insufficiency in the treated limb * Previous varicose vein surgery * Previous venous interventions (e.g. foam sclerotherapy) * Comorbidity or condition that impairs postoperative assessment (e.g. orthopedic diseases of the lower limbs)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life and symptom improvement assessed by the Venous Clinical Severity Score (VCSS) following great saphenous vein stripping in patients with lower limb chronic venous insufficiency | Changes from baseline at 2 and 6 months of follow-up | VCSS ranges from 0-30; higher scores indicate more severe venous disease |
| Quality of life and symptom improvement assessed by the VEINES-QoL/Sym questionnaire following great saphenous vein stripping in patients with lower limb chronic venous insufficiency | Changes from baseline at 2 and 6 months of follow-up | Original VEINES-QoL/Sym converted to 0-100 scale; higher scores indicate better quality of life |
Secondary
| Measure | Time frame |
|---|---|
| Change in the volume of varicose veins assessed by a standardized visual scoring system based on caliber and extent (score range 1-6 per vein, higher scores indicate greater burden) following isolated stripping of the great saphenous vein | Change in the number and volume of varicose veins in the lower limbs 2 months after surgical treatment |
Countries
Brazil
Outcome results
None listed