National Varicose Vein Study - Portugal

Recruiting

• Conditions: Chronic Venous Insufficiency
• Interventions: Procedure: Conventional surgery for great saphenous vein insufficiency

• Registration Number: NCT05625074
• Lead Sponsor: Universidade do Porto

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.

Study Timeline

• Study First Submitted: 2022-10-16
• Status Verified: 2022-11
• Study Start: 2022-11-01
• Study First Submitted QC: 2022-11-14
• Last Update Submitted: 2022-11-14
• Study First Posted: 2022-11-22
• Last Update Posted: 2022-11-22
• Primary Completion: 2023-01-31
• Study Completion: 2023-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CHUP Angiology and Vascular Surgery Service	Conventional surgery for great saphenous vein insufficiency	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)
CHUSJ Angiology and Vascular Surgery Service CHUSJ	Conventional surgery for great saphenous vein insufficiency	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)
CHUC Angiology and Vascular Surgery Service CHUSJ	Conventional surgery for great saphenous vein insufficiency	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)

Primary Outcome Measures

Name	Time	Method
Impact on quality of Life;	In the postoperative period between 25 to 45 days	rVCSS - revised venous clinical seveity score
Antibiotic prophylaxis regimens	In the postoperative period between 25 to 45 days	Duration of the regimen. Beta lactamic vs remaining antibiotics
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
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

Secondary Outcome Measures

Name	Time	Method
Period of work disability	In the postoperative period between 25 and 45 days	measured in days

Trial Locations

Locations (1)

Faculdade de Medicina da Universidade do Porto; 🇵🇹 Porto, Portugal