Varicose Vein in Patients Under the Age of 40

Varicose veins are a result of valvular insufficiency and presented with twisted, enlarged veins. They not only cause cosmetic concerns but also lead to limb edema, skin pigmentation/lipodermatosclerosis, and even venous ulcers. This disease affects a large percentage of the population. Although there have been several researches on the risk factors for varicose veins and the outcomes of alternative therapies , there is currently limited data focusing on varicose veins in young patients. In this case-control study, we wanted to assess the risk factors for varicose veins in patients under the age of 40, as well as their long-term results of surgery.

Study Overview

• Status: Active, not recruiting
• Conditions: Varicose Veins
• Intervention / Treatment: Procedure: Great saphenous vein stripping and ambulatory phlebectomy

• Study Type: Observational
• Enrollment (Actual): 168

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • The First Affiliated Hospital, College of Medicine, Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with primary great saphenous varicose veins (GSVV) and treated by great saphenous vein stripping and ambulatory phlebectomy.

Description

Inclusion Criteria:

1. great saphenous varicose veins (GSVV) with saphenous vein reflux >0.5s.
2. lower extremity venography excluding iliac vein compression;
3. treated by great saphenous vein stripping and ambulatory phlebectomy.
4. the patient had a minimum follow-up of five years.

Exclusion Criteria:

1. secondary varicose veins (defined as varicose veins caused by deep vein thrombosis, iliac venous compression or venous injury etc.);
2. small saphenous veins;
3. treated by endovenous ablation/laser or sclerotherapy alone.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
The younger group; Patients who were under the age of 40	Procedure: Great saphenous vein stripping and ambulatory phlebectomy; All patients included in the study were treated with great saphenous vein stripping and ambulatory phlebectomy.
The older group; Patients who were more than 40 years old	Procedure: Great saphenous vein stripping and ambulatory phlebectomy; All patients included in the study were treated with great saphenous vein stripping and ambulatory phlebectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative varicose veins sequelae	The sequelae of the varicose vein were assessed by Venous Clinical Severity Score (VCSS). The total score is 0~30. The higher scores mean a worse outcome.	Five years after surgery.
Postoperative quality of life	Quality of life was assessed by the Aberdeen Varicose Vein Questionnaire (AVVQ). The total score is 1~100. The higher scores mean a worse outcome.	Five years after surgery.

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): June 30, 2022
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: June 6, 2022
• First Submitted That Met QC Criteria: June 6, 2022
• First Posted (Actual): June 8, 2022

Study Record Updates

• Last Update Posted (Estimate): February 21, 2023
• Last Update Submitted That Met QC Criteria: February 20, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Varicose Veins
• Other Study ID Numbers: IIT20210662A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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