Varicose Veins of Lower LimbNCT07616115
Isolated Great Saphenous Vein Stripping for Treatment of Varicose Veins in Lower Limbs
A study testing Great saphenous vein stripping and Varicose veins removal in people with Varicose Veins of Lower Limb and Saphenous Vein, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Varicose Veins of Lower Limb, Saphenous Vein, Venous Insufficiency
- What is being tested?
- Great saphenous vein stripping and Varicose veins removal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Feb 2019to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital Israelita Albert Einstein
São Paulo, São Paulo, 05652-900
About this study
Official title: Clinical Outcomes and Quality of Life Analysis After Concomitant or Sequential Varicose Vein Resection Following Great Saphenous Vein Stripping in Patients With Lower Limb Varicose Veins
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:
Read more
- 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
- Being tested
- Great saphenous vein stripping, Varicose veins removal
- Medical subject headings
- Venous Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Great saphenous vein strippingProcedure or surgery
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
Varicose veins removalProcedure or surgery
Resection of visible varicose tributaries through staggered mini-incisions
| Study group | Role | What they receive |
|---|---|---|
| Conventional Group | Active comparator | Conventional treatment: great saphenous vein stripping + varicose vein removal Receives: Procedure: Great saphenous vein stripping; Procedure: Varicose veins removal |
| Isolated Saphenectomy Group | Experimental | Saphenous vein stripping without varicose vein removal Receives: Procedure: Great saphenous vein stripping |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Changes from baseline at 2 and 6 months of follow-up
Secondary outcomes (1)
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
Measured: Change in the number and volume of varicose veins in the lower limbs 2 months after surgical treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start1 Feb 2019
- Primary completion28 Feb 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Varicose Veins of Lower LimbStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Israelita Albert Einstein
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nelson Wolosker, Hospital Israelita Albert Einstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07616115
- Sponsor's protocol ID
- CAAE 69606917.7.3002.0083
- Status last verified
- Apr 2026
- First submitted
- 31 Mar 2026
- Last updated
- 29 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes and Quality of Life Analysis After Concomitant or Sequential Varicose Vein Resection Following Great Saphenous Vein Stripping in Patients With Lower Limb Varicose Veins
- ClinicalTrials.gov ID
- NCT07616115
- Acronym / sponsor ID
- CAAE 69606917.7.3002.0083
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Group | Active comparator | Procedure: Great saphenous vein stripping, Procedure: Varicose veins removalConventional treatment: great saphenous vein stripping + varicose vein removal |
| Isolated Saphenectomy Group | Experimental | Procedure: Great saphenous vein strippingSaphenous vein stripping without varicose vein removal |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Great saphenous vein strippingStripping of the great saphenous vein for the treatment of patients with chronic venous disease of the lower limbs associated with great saphenous vein insufficiency | Procedure or surgery | Conventional Group, Isolated Saphenectomy Group |
| Varicose veins removalResection of visible varicose tributaries through staggered mini-incisions | Procedure or surgery | Conventional Group |
Primary outcome
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
Time frame: 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
Time frame: 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
1 secondary outcome
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
Time frame: Change in the number and volume of varicose veins in the lower limbs 2 months after surgical treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Great saphenous vein stripping and Varicose veins removal in people with Varicose Veins of Lower Limb and Saphenous Vein, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Changes from baseline at 2 and 6 months of follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.