Varicose Vein in Patients Under the Age of 40

NCT05410912 | Active Not Recruiting

• 1 other identifier: IIT20210662A
• Study Type: observational
• Target: 168
• Locations: 1 country
• Sites: 1

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.

Conditions

Varicose Veins

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (2)

The younger group

Patients who were under the age of 40

Procedure: 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

Interventions

Great saphenous vein stripping and ambulatory phlebectomy PROCEDURE

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

The older group; The younger group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (1)

The First Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Varicose Veins

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated chief physician

Study Record Dates

• First Submitted: June 6, 2022
• First Posted: June 8, 2022
• Study Start: January 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: December 30, 2024
• Last Updated: September 27, 2024

Record last verified: 2024-09

Locations

CN (1)