National Varicose Vein Study - Portugal

Chronic Venous Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05625074
• Other study ID #: UniversidadePorto
• Status: Recruiting
• Start date: November 1, 2022
• Est. completion date: January 31, 2023

Study information

• Verified date: November 2022
• Source: Universidade do Porto
• Contact: João Rocha Neves, MD/MSc
• Phone: (+351) 910486230
• Email: joaorochaneves[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: January 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Venous Insufficiency
• Varicose Veins
• Venous Insufficiency

Intervention

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

Locations

Country	Name	City	State
Portugal	Faculdade de Medicina da Universidade do Porto	Porto

Sponsors (1)

Lead Sponsor	Collaborator
Universidade do Porto

Country where clinical trial is conducted

Portugal, 

References & Publications (4)

Brand FN, Dannenberg AL, Abbott RD, Kannel WB. The epidemiology of varicose veins: the Framingham Study. Am J Prev Med. 1988 Mar-Apr;4(2):96-101. — View Citation

De Maeseneer MG, Kakkos SK, Aherne T, Baekgaard N, Black S, Blomgren L, Giannoukas A, Gohel M, de Graaf R, Hamel-Desnos C, Jawien A, Jaworucka-Kaczorowska A, Lattimer CR, Mosti G, Noppeney T, van Rijn MJ, Stansby G, Esvs Guidelines Committee, Kolh P, Bastos Goncalves F, Chakfé N, Coscas R, de Borst GJ, Dias NV, Hinchliffe RJ, Koncar IB, Lindholt JS, Trimarchi S, Tulamo R, Twine CP, Vermassen F, Wanhainen A, Document Reviewers, Björck M, Labropoulos N, Lurie F, Mansilha A, Nyamekye IK, Ramirez Ortega M, Ulloa JH, Urbanek T, van Rij AM, Vuylsteke ME. Editor's Choice - European Society for Vascular Surgery (ESVS) 2022 Clinical Practice Guidelines on the Management of Chronic Venous Disease of the Lower Limbs. Eur J Vasc Endovasc Surg. 2022 Feb;63(2):184-267. doi: 10.1016/j.ejvs.2021.12.024. Epub 2022 Jan 11. Erratum in: Eur J Vasc Endovasc Surg. 2022 Aug-Sep;64(2-3):284-285. — View Citation

Lurie F, Passman M, Meisner M, Dalsing M, Masuda E, Welch H, Bush RL, Blebea J, Carpentier PH, De Maeseneer M, Gasparis A, Labropoulos N, Marston WA, Rafetto J, Santiago F, Shortell C, Uhl JF, Urbanek T, van Rij A, Eklof B, Gloviczki P, Kistner R, Lawrence P, Moneta G, Padberg F, Perrin M, Wakefield T. The 2020 update of the CEAP classification system and reporting standards. J Vasc Surg Venous Lymphat Disord. 2020 May;8(3):342-352. doi: 10.1016/j.jvsv.2019.12.075. Epub 2020 Feb 27. Erratum in: J Vasc Surg Venous Lymphat Disord. 2021 Jan;9(1):288. — View Citation

O'Donnell TF, Balk EM, Dermody M, Tangney E, Iafrati MD. Recurrence of varicose veins after endovenous ablation of the great saphenous vein in randomized trials. J Vasc Surg Venous Lymphat Disord. 2016 Jan;4(1):97-105. doi: 10.1016/j.jvsv.2014.11.004. Epub 2015 Apr 11. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Antibiotic prophylaxis regimens	Duration of the regimen. Beta lactamic vs remaining antibiotics	In the postoperative period between 25 to 45 days
Primary	Impact on quality of Life;	Eq5D5L; 5-level EQ-5D version (EQ-5D-5L)	In the postoperative period between 25 to 45 days
Primary	Impact on quality of Life;	CIVIQ14 - ChronIc Venous Insufficiency QOL Questionnaire (CIVIQ)	In the postoperative period between 25 to 45 days
Primary	Impact on quality of Life;	rVCSS - revised venous clinical seveity score	In the postoperative period between 25 to 45 days
Primary	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
Primary	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	Period of work disability	measured in days	In the postoperative period between 25 and 45 days