ISRCTN ISRCTN12085308
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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

Dr Tim Sigterman
Scientific

Tegelseweg 210
Venlo
5912BL
Netherlands

Phone +31(0)773205555
Email tsigterman@viecuri.nl

Study information

Study designProspective cohort
Primary study designObservational
Secondary study designCohort study
Study setting(s)Hospital
Study typeQuality of life
Participant information sheet No participant information sheet available
Scientific titleThe 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 objectivesWe 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) studiedVaricose veins
InterventionA 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 typeProcedure/Surgery
Primary outcome measureQuality of life measured using the CIVIQ-20 questionnaire at baseline, 6- and 12-months
Secondary outcome measuresDepression and anxiety measured using the HADS at baseline, 6- and 12-months
Overall study start date01/06/2011
Completion date31/12/2013

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants442
Total final enrolment442
Key inclusion criteria1. 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 criteriaDoes not meet inclusion criteria
Date of first enrolment01/01/2012
Date of final enrolment31/12/2013

Locations

Countries of recruitment

  • Netherlands

Study participating centres

Zuyderland Medical Center
Henri Dunantstraat 5
Heerlen
6459
Netherlands
Maastricht University Medical Center
Prof Debeyeplein 30
Maastricht
6229
Netherlands
Centrum Oosterwal
Comeniusstraat 3
Alkmaar
1817 MS
Netherlands
Westfriesgasthuis
Maelsonstraat 3
Hoorn
1624 NP
Netherlands
Braam Kliniek
Zoom 10
Assen
9405 PS
Netherlands

Sponsor information

Zuyderland Medical Center
Hospital/treatment centre

Henri dunantstraat 5
Heerlen
6419PC
Netherlands

Phone 088 459 7777
Email info@zuyderland.nl
Website www.zuyderland.nl
ROR logo "ROR" https://ror.org/03bfc4534

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date01/10/2019
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryStored in repository
Publication and dissemination planSubmitted to Journal of Vascular Surgery: venous and lymphatic disorders
IPD sharing planThe 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