National Varicose Vein Study - Portugal

Universidade do Porto

Status

Enrolling

Conditions

Chronic Venous Insufficiency

Treatments

Procedure: Conventional surgery for great saphenous vein insufficiency

Study type

Observational

Funder types

Other

Identifiers

NCT05625074

UniversidadePorto

Details and patient eligibility

About

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.

Full 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.

Enrollment

250 estimated patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients treated at CHUP, CHUSJ and CHUC
Male and female;
Age over 18 years;
All clinical presentations (C) included in the CEAP classification system;
Period from November 2022 onwards;
Conventional surgical treatment of at least one great saphenous vein;
Patients treated using the following techniques: arch ligation +/- trunk stripping.

Exclusion criteria

Exclusive or concomitant treatment with endovenous surgery (thermal ablation by laser or radiofrequency...);
Treatment by conservative conventional surgery of the great saphenous vein (CHIVA, ASVAL);
Varicose surgery not involving the great saphenous vein;
Age under 18 years;
Patients treated in hospital units not covered by the study.

Trial design

250 participants in 3 patient groups

CHUP Angiology and Vascular Surgery Service

Description:

A transversal study, recruiting consecutive patients undergoing great saphenous vein saphenectomy by stripping technique. Evaluation and Qol Questionnaires performed at the 30th day of the postoperative period (acceptable scope - 25 to 45 days)

Treatment:

Procedure: Conventional surgery for great saphenous vein insufficiency

CHUSJ Angiology and Vascular Surgery Service CHUSJ

Description:

Treatment:

Procedure: Conventional surgery for great saphenous vein insufficiency

CHUC Angiology and Vascular Surgery Service CHUSJ

Description:

Treatment:

Procedure: Conventional surgery for great saphenous vein insufficiency