Physical suffering in patients with venous disease
ISRCTN | ISRCTN12085308 |
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DOI | https://doi.org/10.1186/ISRCTN12085308 |
Secondary identifying numbers | 11-4-110 |
- Submission date
- 16/07/2019
- Registration date
- 23/07/2019
- Last edited
- 28/05/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Superficial venous disease (SVD) is a very common disease and much research has been done towards finding the ideal treatment and discovering the pathophysiology of SVD. Not much is known about the psychological burden of SVD. Current guidelines and scientific publications tend to focus on clinical and physiological aspects of SVD. The aim of this study was to relate the changes in Quality-of-Life(QoL) after SVD treatment to possible changes in psychic distress (PD).
Who can participate?
Patients aged 18 years and older with SVD.
What does the study involve?
Patients with SVD are divided into two groups. One group is treated by sclerocompression therapy (SCT), the other using laser ablation (LA), radiofrequency ablation (RFA), or phlebectomy(PHL). Patients complete questionnaires to assess quality of life and mental health at baseline, 6- and 12-months.
What are the possible benefits and risks of participating?
Benefits: No direct benefits, but this research will improve future treatment of the condition.
Risks: None
Where is the study run from?
1. Zuyderland Medical Center
2. Maastricht University Medical Center
3. Centrum Oosterwal
4. Westfriesgasthuis
5. Braam Kliniek
All in the Netherlands
When is the study starting and how long is it expected to run for?
January 2012 to December 2013
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Tim Sigterman
tsigterman@viecuri.nl
Contact information
Scientific
Tegelseweg 210
Venlo
5912BL
Netherlands
Phone | +31(0)773205555 |
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tsigterman@viecuri.nl |
Study information
Study design | Prospective cohort |
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Primary study design | Observational |
Secondary study design | Cohort study |
Study setting(s) | Hospital |
Study type | Quality of life |
Participant information sheet | No participant information sheet available |
Scientific title | The relationship between psychic distress and impairment of disease-specific quality-of-life compared between sclerocompression therapy and invasive treatments in patients with superficial venous disease during a one-year follow-up |
Study objectives | We hypothesize that an increased clinical severity and impaired quality of life (QoL) in superficial venous disease (SVD) will also increase psychic distress (PD) and that an invasive intervention (group 2) will improve outcome compared to sclerocompression therapy (SCT) (group 1). |
Ethics approval(s) | Approved 30/11/2011, Medical Ethical Committee of the Maastricht Univerisity Medical Center (P Debyelann 25, Maastricht, 6229 HX, The Netherlands; +31(0)43-387 65 43; secretariaat.mec@mumc.nl), ref: WMO/METC 11-4-110 |
Health condition(s) or problem(s) studied | Varicose veins |
Intervention | A prospective cohort was set up with the assistance of five specialized vein clinics in the Netherlands. Patients were divided into two groups: 1. C1-C3 patients treated by SCT 2. C1-C6 patients treated invasively laser ablation (LA), radiofrequency ablation (RFA), phlebectomy(PHL) Patients completed a disease-specific QoL questionnaire (CIVIQ-20) and a questionnaire to assess PD (HADS) at baseline, 6- and 12-months. C1-C6 refer to the visual classification of the severity of the SVD: C0 – the lowest degree in severity, means that there is no sign of venous disease when looking at the leg C1 – means that the person has spider or reticular veins when looking at the leg C2 – means that varicose veins are present when looking at the leg C3 – denotes the presence of edema (swelling) of the ankle. Best visualized from the back rather than the front. C4a,b – includes pigmentation (darkening) of the skin, eczema (redness, itching), lipodermatosclerosis (hardening of the soft tissues), and atrophie blanche (a whitish skin area) C5 – means that a healed venous ulcer is present when looking at the leg C6 – is the most severe category, means that an active open venous ulcer is seen on the skin |
Intervention type | Procedure/Surgery |
Primary outcome measure | Quality of life measured using the CIVIQ-20 questionnaire at baseline, 6- and 12-months |
Secondary outcome measures | Depression and anxiety measured using the HADS at baseline, 6- and 12-months |
Overall study start date | 01/06/2011 |
Completion date | 31/12/2013 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 442 |
Total final enrolment | 442 |
Key inclusion criteria | 1. 18 years of age or older 2. Fluent in Dutch language 3. C1 to C6 (CEAP) class intended to be treated with either laser(LA), radiofrequency ablation (RFA), phlebectomy(PHL) or sclerocompression therapy (SCT) |
Key exclusion criteria | Does not meet inclusion criteria |
Date of first enrolment | 01/01/2012 |
Date of final enrolment | 31/12/2013 |
Locations
Countries of recruitment
- Netherlands
Study participating centres
Heerlen
6459
Netherlands
Maastricht
6229
Netherlands
Alkmaar
1817 MS
Netherlands
Hoorn
1624 NP
Netherlands
Assen
9405 PS
Netherlands
Sponsor information
Hospital/treatment centre
Henri dunantstraat 5
Heerlen
6419PC
Netherlands
Phone | 088 459 7777 |
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info@zuyderland.nl | |
Website | www.zuyderland.nl |
https://ror.org/03bfc4534 |
Funders
Funder type
Other
No information available
Results and Publications
Intention to publish date | 01/10/2019 |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Stored in repository |
Publication and dissemination plan | Submitted to Journal of Vascular Surgery: venous and lymphatic disorders |
IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the general investigator, A. Krasznai akrasznai@zuyderland.nl on reasonable request |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | 27/05/2021 | 28/05/2021 | Yes | No |
Editorial Notes
28/05/2021: Publication reference and total final enrolment added.
27/08/2019: Internal review.
19/07/2019: Trial’s existence confirmed by Medical Ethical Committee of the Maastricht Univerisity Medical Center