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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
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| 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) |
| |
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional surgery for great saphenous vein insufficiency | Procedure | Arch ligation and stripping of great saphenous vein. Prophilatic anticoagulation - Low molecular weight heparin vs DOACs Antibiotics Non-steoridal anti-inflamatory drugs |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Period of work disability | measured in days | In the postoperative period between 25 and 45 days |
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Inclusion Criteria:
Exclusion Criteria:
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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).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| João Rocha Neves, MD/MSc | Contact | (+351) 910486230 | joaorochaneves@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculdade de Medicina da Universidade do Porto | Recruiting | Porto | 4200-319 | Portugal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35027279 | Background | 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. | |
| 26946904 |
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| ID | Term |
|---|---|
| D014689 | Venous Insufficiency |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Background |
| 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. |
| 3395496 | Background | 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. |
| 32113854 | Background | 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. |