Condition category
Circulatory System
Date applied
16/07/2019
Date assigned
23/07/2019
Last edited
27/08/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

www.zuyderland.nl

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

Publication citations

Additional files

Editorial Notes

27/08/2019: Internal review. 19/07/2019: Trial’s existence confirmed by Medical Ethical Committee of the Maastricht Univerisity Medical Center