National Varicose Vein Study - Portugal

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Venous Insufficiency
• Intervention / Treatment: Procedure: Conventional surgery for great saphenous vein insufficiency

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 Type: Observational
• Enrollment (Anticipated): 250

Contacts and Locations

• Study Contact: Name: João Rocha Neves, MD/MSc; Phone Number: (+351) 910486230; Email: joaorochaneves@hotmail.com

Study Locations

• Portugal
  • Porto, Portugal, 4200-319
    • Recruiting
    • Faculdade de Medicina da Universidade do Porto
    • Contact: Joao Rocha-Neves; Phone Number: 910486230; Email: joaorochaneves@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 98 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients submitted to surgical treatment of symptomatic insufficiency of the great saphenous vein by conventional surgery (arch ligation +/- trunk stripping), in the postoperative period between 25 and 45 days, in the hospital centers involved in the study starting in November 2022 onwards, until the desired sample volume is reached (50 patients per center).

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Crossover
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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)	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; Other Names: Arch ligation and stripping of great saphenous vein
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)	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; Other Names: Arch ligation and stripping of great saphenous vein
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)	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; Other Names: Arch ligation and stripping of great saphenous vein

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universidade do Porto

Publications and helpful links

General Publications

• 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.
• 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. Erratum In: Eur J Vasc Endovasc Surg. 2022 Aug-Sep;64(2-3):284-285.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Anticipated): January 31, 2023
• Study Completion (Anticipated): January 31, 2023

Study Registration Dates

• First Submitted: October 16, 2022
• First Submitted That Met QC Criteria: November 14, 2022
• First Posted (Actual): November 22, 2022

Study Record Updates

• Last Update Posted (Actual): November 22, 2022
• Last Update Submitted That Met QC Criteria: November 14, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Venous Insufficiency; Conventional great vein surgery
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Venous Insufficiency; Varicose Veins
• Other Study ID Numbers: UniversidadePorto

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No