National Varicose Vein Study - Portugal

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Venous Insufficiency

Intervention / Treatment
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* Procedure: Conventional surgery for great saphenous vein insufficiency


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CHUP Angiology and Vascular Surgery Service<br>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) | Procedure: Conventional surgery for great saphenous vein insufficiency<br>* Arch ligation and stripping of great saphenous vein. Prophilatic anticoagulation - Low molecular weight heparin vs DOACs Antibiotics Non-steoridal anti-inflamatory drugs<br>* Other names: Arch ligation and stripping of great saphenous vein;|
| CHUSJ Angiology and Vascular Surgery Service CHUSJ<br>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) | Procedure: Conventional surgery for great saphenous vein insufficiency<br>* Arch ligation and stripping of great saphenous vein. Prophilatic anticoagulation - Low molecular weight heparin vs DOACs Antibiotics Non-steoridal anti-inflamatory drugs<br>* Other names: Arch ligation and stripping of great saphenous vein;|
| CHUC Angiology and Vascular Surgery Service CHUSJ<br>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) | Procedure: Conventional surgery for great saphenous vein insufficiency<br>* Arch ligation and stripping of great saphenous vein. Prophilatic anticoagulation - Low molecular weight heparin vs DOACs Antibiotics Non-steoridal anti-inflamatory drugs<br>* Other names: Arch ligation and stripping of great saphenous vein;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacological and/or mechanical thromboprophylaxis | Regimen (low molecular weight Heparin vs direct oral anticoagulant; elastic stockings). duration of the thromboprophilaxis regimen | In the postoperative period between 25 and 45 days | 
| Antibiotic prophylaxis regimens | Duration of the regimen. Beta lactamic vs remaining antibiotics | In the postoperative period between 25 to 45 days | 
| Impact on quality of Life; | Eq5D5L; 5-level EQ-5D version (EQ-5D-5L) | In the postoperative period between 25 to 45 days | 
| Impact on quality of Life; | CIVIQ14 - ChronIc Venous Insufficiency QOL Questionnaire (CIVIQ) | In the postoperative period between 25 to 45 days | 
| Impact on quality of Life; | rVCSS - revised venous clinical seveity score | In the postoperative period between 25 to 45 days | 
| Compliance with drug therapy; | How many days were recomended to take the drug; How many days the patient took the drug | In the postoperative period between 25 and 45 days | 
| Complications and extraordinary recourse to health care | Observation in the outpatient clinic and urgency department | In the postoperative period between 25 and 45 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Period of work disability | measured in days | In the postoperative period between 25 and 45 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Venous Insufficiency, Conventional great vein surgery