Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Participants will:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Group | Active Comparator | Conventional treatment: great saphenous vein stripping + varicose vein removal |
|
| Isolated Saphenectomy Group | Experimental | Saphenous vein stripping without varicose vein removal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Great saphenous vein stripping | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | VCSS ranges from 0-30; higher scores indicate more severe venous disease | Changes from baseline at 2 and 6 months of follow-up |
| 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 | Original VEINES-QoL/Sym converted to 0-100 scale; higher scores indicate better quality of life | Changes from baseline at 2 and 6 months of follow-up |
| Measure | Description | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Israelita Albert Einstein | São Paulo | São Paulo | 05652-900 | Brazil |
De-identified individual participant data collected during the study may be available to other researchers upon reasonable request. Researchers may request access to de-identified IPD by contacting the corresponding author. Requests will be evaluated by the principal investigator.
Available upon manuscript publication and for 3 years thereafter.
De-identified individual participant data and supporting information will be available to researchers upon reasonable request. Requests should be directed to the corresponding author (fsoaresportela@gmail.com) and will be reviewed by the principal investigator.
Not provided
Not provided
| ID | Term |
|---|---|
| D014689 | Venous Insufficiency |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Varicose veins removal | Procedure | Resection of visible varicose tributaries through staggered mini-incisions |
|