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OpenTrials
Completed

NCT Number: NCT07616115

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

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

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Key information

Conditions

Varicose Veins of Lower Limb Cardiovascular Diseases Saphenous Vein Vascular Diseases Venous Insufficiency

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Israelita Albert Einstein

São Paulo, 05652-900, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Varicose veins removal

Procedure

Resection of visible varicose tributaries through staggered mini-incisions

Primary outcomes

  1. 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

  2. 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

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

    Time frame: Change in the number and volume of varicose veins in the lower limbs 2 months after surgical treatment

Sponsors and collaborators

Lead sponsor

Hospital Israelita Albert Einstein

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
May 29, 2026
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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