National Varicose Vein Study - Portugal

NCT ID: NCT05625074

Last Updated: 2022-11-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2023-01-31

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.

Conditions

Chronic Venous Insufficiency

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

CHUP Angiology and Vascular Surgery Service

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)

Conventional surgery for great saphenous vein insufficiency

Intervention Type: PROCEDURE

Arch ligation and stripping of great saphenous vein. Prophilatic anticoagulation - Low molecular weight heparin vs DOACs Antibiotics Non-steoridal anti-inflamatory drugs

CHUSJ Angiology and Vascular Surgery Service CHUSJ

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)

Conventional surgery for great saphenous vein insufficiency

Intervention Type: PROCEDURE

Arch ligation and stripping of great saphenous vein. Prophilatic anticoagulation - Low molecular weight heparin vs DOACs Antibiotics Non-steoridal anti-inflamatory drugs

CHUC Angiology and Vascular Surgery Service CHUSJ

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)

Conventional surgery for great saphenous vein insufficiency

Intervention Type: PROCEDURE

Arch ligation and stripping of great saphenous vein. Prophilatic anticoagulation - Low molecular weight heparin vs DOACs Antibiotics Non-steoridal anti-inflamatory drugs

Interventions

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

Intervention Type: PROCEDURE

Other Intervention Names

Arch ligation and stripping of great saphenous vein

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade do Porto

OTHER

Sponsor Role: lead

Responsible Party

João Rocha Neves

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculdade de Medicina da Universidade do Porto

Porto, , Portugal

Site Status: RECRUITING

Countries

Portugal

Central Contacts

João Rocha Neves, MD/MSc

Role: CONTACT

joaorochaneves@hotmail.com

(+351) 910486230

Facility Contacts

Joao Rocha-Neves

Role: primary

joaorochaneves@hotmail.com

910486230

References

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.

Reference Type: BACKGROUND

PMID: 3395496 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32113854 (View on PubMed)

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, Chakfe 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, Bjorck 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. No abstract available.

Reference Type: BACKGROUND

PMID: 35027279 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26946904 (View on PubMed)

Other Identifiers

UniversidadePorto

Identifier Type: -

Identifier Source: org_study_id