Clinical trial NCT05625074: National Varicose Vein Study - Portugal
Official title: The Portuguese National Health Service Reality in Varicose Vein Surgery - a Transversal Study on the Early Postoperative of Superficial Venous Surgery.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Venous Insufficiency
Keywords: Venous Insufficiency
Conventional great vein surgery
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
First posted: 2022-11-22
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
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).

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.

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.

Primary outcomes:
measure: Pharmacological and/or mechanical thromboprophylaxis
timeFrame: In the postoperative period between 25 and 45 days
measure: Antibiotic prophylaxis regimens
timeFrame: In the postoperative period between 25 to 45 days
measure: Impact on quality of Life;
timeFrame: In the postoperative period between 25 to 45 days
measure: Impact on quality of Life;
timeFrame: In the postoperative period between 25 to 45 days
measure: Impact on quality of Life;
timeFrame: In the postoperative period between 25 to 45 days
measure: Compliance with drug therapy;
timeFrame: In the postoperative period between 25 and 45 days
measure: Complications and extraordinary recourse to health care
timeFrame: In the postoperative period between 25 and 45 days
Secondary outcomes:
measure: Period of work disability
timeFrame: In the postoperative period between 25 and 45 days
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Faculdade de Medicina da Universidade do Porto
Study officials:
References:
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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.
citation: 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.
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.