NCT05625074

National Varicose Vein Study - Portugal

The Portuguese National Health Service Reality in Varicose Vein Surgery - a Transversal Study on the Early Postoperative of Superficial Venous Surgery.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: Universidade do Porto · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The National Varicose Vein Study is a cross-sectional, multicenter, observational study. The primary goal is to evaluate the 30 days outcome of the conventional great saphenous vein surgery (stripping) in the treatment of the symptomatic chronic venous insufficiency, comparing the results of difference Portuguese's health centers, comparing the following variables: thrombo-prophylaxis (pharmacology or mechanic; compliance); antimicrobial prophylaxis; quality of life; medication compliance; complications and work incapacity period.

Detailed description

Chronic venous disease is one of the most prevalent pathologies in the world population. It presents a spectrum of variable manifestations, culminating in the most severe form, active venous ulcer. The clinical evaluation, the study of venous anatomy by echo- Doppler and the indications for surgical treatment are standardized in guidelines. The same applies to the techniques for surgical treatment that, in the long term, present equally satisfactory results. Thus, currently, in the Portuguese national health system, the surgical technique most frequently used is conventional surgery. As for postoperative care, namely thromboprophylaxis regimens, analgesia regimens, there is greater variability in its application between clinics and institutions, which may result in significant differences in postoperative recovery. In this way, we intend to develop an observational, cross-sectional and multicenter study, comparing postoperative care protocols and patient compliance and impact on quality of life, as well as absence from work. The primary goal is to evaluate the 30 days outcome of the conventional great saphenous vein surgery (stripping) in the treatment of the symptomatic chronic venous insufficiency, comparing the results of difference Portuguese's health centers, comparing the following variables: thrombo-prophylaxis (pharmacology or mechanic; compliance); antimicrobial prophylaxis; quality of life; medication compliance; complications and work incapacity period.

Conditions

• Chronic Venous Insufficiency

Interventions

Type	Name	Description
PROCEDURE	Conventional surgery for great saphenous vein insufficiency	Arch ligation and stripping of great saphenous vein. Prophilatic anticoagulation - Low molecular weight heparin vs DOACs Antibiotics Non-steoridal anti-inflamatory drugs

Timeline

• Start date: 2022-11-01
• Primary completion: 2023-01-31
• Completion: 2023-01-31
• First posted: 2022-11-22
• Last updated: 2022-11-22

Locations

1 site across 1 country: Portugal

Regulatory

• FDA-regulated drug study
• FDA-regulated device study