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

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:

• 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 Overview

• Status: Completed
• Conditions: Venous Insufficiency; Varicose Veins of Lower Limb; Saphenous Vein
• Intervention / Treatment: Procedure: Great saphenous vein stripping; Procedure: Varicose veins removal

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • São Paulo, São Paulo, Brazil, 05652-900
      • Hospital Israelita Albert Einstein

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional Group; Conventional treatment: great saphenous vein stripping + varicose vein removal	Procedure: Great saphenous vein stripping; 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; Procedure: Varicose veins removal; Resection of visible varicose tributaries through staggered mini-incisions
Experimental: Isolated Saphenectomy Group; Saphenous vein stripping without varicose vein removal	Procedure: Great saphenous vein stripping; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Hospital Israelita Albert Einstein

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Actual): February 28, 2024
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: March 31, 2026
• First Submitted That Met QC Criteria: May 26, 2026
• First Posted (Actual): May 29, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Venous Insufficiency
• Other Study ID Numbers: CAAE 69606917.7.3002.0083

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Available upon manuscript publication and for 3 years thereafter.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No