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

NCT07616115 | Completed

• 1 other identifier: CAAE 69606917.7.3002.0083
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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

Conditions

Varicose Veins of Lower Limb; Saphenous Vein; Venous Insufficiency

Outcome Measures

Primary Outcomes (2)

• 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

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

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

Study Arms (2)

Conventional Group

ACTIVE COMPARATOR

Conventional treatment: great saphenous vein stripping + varicose vein removal

Procedure: Great saphenous vein stripping; Procedure: Varicose veins removal

Isolated Saphenectomy Group

EXPERIMENTAL

Saphenous vein stripping without varicose vein removal

Procedure: Great saphenous vein stripping

Interventions

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

Conventional Group; Isolated Saphenectomy Group

Varicose veins removal PROCEDURE

Resection of visible varicose tributaries through staggered mini-incisions

Conventional Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead

Study Sites (1)

Hospital Israelita Albert Einstein

São Paulo, São Paulo, 05652-900, Brazil

Location

MeSH Terms

Conditions

Venous Insufficiency

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vascular Surgeon, Hospital Israelita Alber Einstein

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: May 29, 2026
• Study Start: February 1, 2019
• Primary Completion: February 28, 2024
• Study Completion: June 30, 2024
• Last Updated: May 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Available upon manuscript publication and for 3 years thereafter.
• Access Criteria: 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.

Locations

BR (1)