CompletedNot Applicable

Isolated Great Saphenous Vein Stripping for Treatment of Varicose Veins in Lower Limbs

Brazil34 participantsStarted 2019-02-01

Plain-language 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

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 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

Timeframe: Changes from baseline at 2 and 6 months of follow-up

Trial details

NCT IDNCT07616115

SponsorHospital Israelita Albert Einstein

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-02-28

View on ClinicalTrials.gov More Varicose Veins of Lower Limb trials

Plain-language summary

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: 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

Timeframe: Changes from baseline at 2 and 6 months of follow-up