Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Dr Tim Sigterman
ORCID ID
Contact details
Tegelseweg 210
Venlo
5912BL
Netherlands
+31(0)773205555
tsigterman@viecuri.nl
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
11-4-110
Study information
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
Acronym
Study hypothesis
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
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
Study design
Prospective cohort
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
No participant information sheet available
Condition
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
Phase
Drug names
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 trial start date
01/06/2011
Overall trial end date
31/12/2013
Reason abandoned (if study stopped)
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
442
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/01/2012
Recruitment end date
31/12/2013
Locations
Countries of recruitment
Netherlands
Trial participating centre
Zuyderland Medical Center
Henri Dunantstraat 5
Heerlen
6459
Netherlands
Trial participating centre
Maastricht University Medical Center
Prof Debeyeplein 30
Maastricht
6229
Netherlands
Trial participating centre
Centrum Oosterwal
Comeniusstraat 3
Alkmaar
1817 MS
Netherlands
Trial participating centre
Westfriesgasthuis
Maelsonstraat 3
Hoorn
1624 NP
Netherlands
Trial participating centre
Braam Kliniek
Zoom 10
Assen
9405 PS
Netherlands
Sponsor information
Organisation
Zuyderland Medical Center
Sponsor details
Henri dunantstraat 5
Heerlen
6419PC
Netherlands
088 459 7777
info@zuyderland.nl
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Submitted to Journal of Vascular Surgery: venous and lymphatic disorders
IPD sharing statement:
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
Intention to publish date
01/10/2019
Participant level data
Stored in repository
Basic results (scientific)
Publication list