Varicose Vein in Patients Under the Age of 40

Varicose Veins Clinical Trial

Official title:

Varicose Vein in Patients Under the Age of 40

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05410912
• Other study ID #: IIT20210662A
• Status: Active, not recruiting
• Start date: January 1, 2021
• Est. completion date: December 30, 2023

Study information

• Verified date: February 2023
• Source: First Affiliated Hospital of Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 168
• Est. completion date: December 30, 2023
• Est. primary completion date: June 30, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Varicose Veins

Intervention

Procedure:
• Great saphenous vein stripping and ambulatory phlebectomy
All patients included in the study were treated with great saphenous vein stripping and ambulatory phlebectomy.

Locations

Country	Name	City	State
China	The First Affiliated Hospital, College of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.