Varicose Vein in Patients Under the Age of 40

Active, not recruiting

• Conditions: Varicose Veins
• Interventions: Procedure: Great saphenous vein stripping and ambulatory phlebectomy

• Registration Number: NCT05410912
• Lead Sponsor: First Affiliated Hospital of Zhejiang University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2022-06-06
• Study First Submitted QC: 2022-06-06
• Study First Posted: 2022-06-08
• Primary Completion: 2022-06-30
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-20
• Last Update Posted: 2023-02-21
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 168

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
The younger group	Great saphenous vein stripping and ambulatory phlebectomy	Patients who were under the age of 40
The older group	Great saphenous vein stripping and ambulatory phlebectomy	Patients who were more than 40 years old

Primary Outcome Measures

Name	Time	Method
Postoperative varicose veins sequelae	Five years after surgery.	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.
Postoperative quality of life	Five years after surgery.	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.

Trial Locations

Locations (1)

The First Affiliated Hospital, College of Medicine, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China