Chronic Venous InsufficiencyNCT05625074
National Varicose Vein Study - Portugal
An observational study of Chronic Venous Insufficiency, run by Universidade do Porto at 1 site in Portugal.
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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Chronic Venous Insufficiency
- What is being tested?
- Conventional surgery for great saphenous vein insufficiency
- Type of treatment
- Surgery or procedure
- How many people
- 250 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Nov 2022to 31 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Faculdade de Medicina da Universidade do Porto
Porto, 4200-319
Joao Rocha-Neves, 910486230, joaorochaneves@hotmail.com
About this study
Official title: 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.
Read the 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
- Being tested
- Conventional surgery for great saphenous vein insufficiency
- Keywords
- Venous Insufficiency, Conventional great vein surgery
- Medical subject headings
- Venous Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional surgery for great saphenous vein insufficiencyProcedure or surgery
Also called Arch ligation and stripping of great saphenous vein
Arch ligation and stripping of great saphenous vein. Prophilatic anticoagulation - Low molecular weight heparin vs DOACs Antibiotics Non-steoridal anti-inflamatory drugs
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Procedure: Conventional surgery for great saphenous vein insufficiency | |
| 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) Receives: Procedure: Conventional surgery for great saphenous vein insufficiency | |
| 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) Receives: Procedure: Conventional surgery for great saphenous vein insufficiency |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacological and/or mechanical thromboprophylaxis
Regimen (low molecular weight Heparin vs direct oral anticoagulant; elastic stockings). duration of the thromboprophilaxis regimen
Measured: In the postoperative period between 25 and 45 days
Antibiotic prophylaxis regimens
Duration of the regimen. Beta lactamic vs remaining antibiotics
Measured: In the postoperative period between 25 to 45 days
Impact on quality of Life;
Eq5D5L; 5-level EQ-5D version (EQ-5D-5L)
Measured: In the postoperative period between 25 to 45 days
Impact on quality of Life;
CIVIQ14 - ChronIc Venous Insufficiency QOL Questionnaire (CIVIQ)
Measured: In the postoperative period between 25 to 45 days
Impact on quality of Life;
rVCSS - revised venous clinical seveity score
Measured: 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
Measured: In the postoperative period between 25 and 45 days
Complications and extraordinary recourse to health care
Observation in the outpatient clinic and urgency department
Measured: In the postoperative period between 25 and 45 days
Secondary outcomes (1)
Period of work disability
measured in days
Measured: In the postoperative period between 25 and 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2022
- Study start1 Nov 2022
- Primary completion31 Jan 2023 (estimated)
- Study completion31 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Venous InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, João Rocha Neves, Universidade do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05625074
- Sponsor's protocol ID
- UniversidadePorto
- Status last verified
- Nov 2022
- First submitted
- 16 Oct 2022
- Last updated
- 22 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 35027279O'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.
PubMed 26946904Brand 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.
PubMed 3395496Lurie 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.
PubMed 32113854
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Portuguese National Health Service Reality in Varicose Vein Surgery - a Transversal Study on the Early Postoperative of Superficial Venous Surgery.
- ClinicalTrials.gov ID
- NCT05625074
- Acronym / sponsor ID
- UniversidadePorto
- Conditions
- Chronic Venous Insufficiency
- Keywords
- Venous Insufficiency, Conventional great vein surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 31 Jan 2023 (estimated)
- Study completion
- 31 Jan 2023 (estimated)
- First posted
- 22 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CHUP Angiology and Vascular Surgery Service | – | Procedure: Conventional surgery for great saphenous vein insufficiencyA 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) |
| CHUSJ Angiology and Vascular Surgery Service CHUSJ | – | Procedure: Conventional surgery for great saphenous vein insufficiencyA 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 | – | Procedure: Conventional surgery for great saphenous vein insufficiencyA 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) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional surgery for great saphenous vein insufficiencyAlso: Arch ligation and stripping of great saphenous veinArch ligation and stripping of great saphenous vein. Prophilatic anticoagulation - Low molecular weight heparin vs DOACs Antibiotics Non-steoridal anti-inflamatory drugs | Procedure or surgery | CHUC Angiology and Vascular Surgery Service CHUSJ, CHUP Angiology and Vascular Surgery Service, CHUSJ Angiology and Vascular Surgery Service CHUSJ |
Primary outcome
Pharmacological and/or mechanical thromboprophylaxis
Time frame: In the postoperative period between 25 and 45 days
Regimen (low molecular weight Heparin vs direct oral anticoagulant; elastic stockings). duration of the thromboprophilaxis regimen
Antibiotic prophylaxis regimens
Time frame: In the postoperative period between 25 to 45 days
Duration of the regimen. Beta lactamic vs remaining antibiotics
Impact on quality of Life;
Time frame: In the postoperative period between 25 to 45 days
Eq5D5L; 5-level EQ-5D version (EQ-5D-5L)
Impact on quality of Life;
Time frame: In the postoperative period between 25 to 45 days
CIVIQ14 - ChronIc Venous Insufficiency QOL Questionnaire (CIVIQ)
Impact on quality of Life;
Time frame: In the postoperative period between 25 to 45 days
rVCSS - revised venous clinical seveity score
Compliance with drug therapy;
Time frame: In the postoperative period between 25 and 45 days
How many days were recomended to take the drug; How many days the patient took the drug
Complications and extraordinary recourse to health care
Time frame: In the postoperative period between 25 and 45 days
Observation in the outpatient clinic and urgency department
1 secondary outcome
Period of work disability
Time frame: In the postoperative period between 25 and 45 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2022.
- Background: PubMed 35027279De 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.
- Background: PubMed 26946904O'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.
- Background: PubMed 3395496Brand 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.
- Background: PubMed 32113854Lurie 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Venous Insufficiency, run by Universidade do Porto at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact João Rocha Neves, MD/MSc ((+351) 910486230, joaorochaneves@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacological and/or mechanical thromboprophylaxis (time frame: In the postoperative period between 25 and 45 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05625074, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2022; AzTrials last refreshed its copy on 6 Nov 2026.