Chronic Venous Insufficiency
Conditions
Keywords
Venous Insufficiency, Conventional great vein surgery
Brief 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.
Interventions
PROCEDUREConventional 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
Sponsors
Universidade do Porto
Study design
Observational model
CASE_CROSSOVER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacological and/or mechanical thromboprophylaxis | In the postoperative period between 25 and 45 days | Regimen (low molecular weight Heparin vs direct oral anticoagulant; elastic stockings). duration of the thromboprophilaxis regimen |
| Antibiotic prophylaxis regimens | In the postoperative period between 25 to 45 days | Duration of the regimen. Beta lactamic vs remaining antibiotics |
| Impact on quality of Life; | In the postoperative period between 25 to 45 days | Eq5D5L; 5-level EQ-5D version (EQ-5D-5L) |
| Compliance with drug therapy; | In the postoperative period between 25 and 45 days | How many days were recomended to take the drug; How many days the patient took the drug |
| Complications and extraordinary recourse to health care | In the postoperative period between 25 and 45 days | Observation in the outpatient clinic and urgency department |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Period of work disability | In the postoperative period between 25 and 45 days | measured in days |
Countries
Portugal
Contacts
Primary ContactJoão Rocha Neves, MD/MSc
Outcome results
None listed