Varicose Vein Disease
Conditions
Keywords
Incompetence of the great saphenous vein.
Brief summary
Varicose vein disease is a common health problem, which causes much discomfort to patients. Nowadays treatment modalities for greater saphenous veins include surgery and duplex guided foam sclerotherapy. These are two equally accepted and applied treatments for the same patient population. Choice of treatment often depends on the referral preference of the General Practitioner. Until now data are missing which treatment is more cost effective. The current proposal aims at comparing the effects, costs and patient preferences between duplex guided foam sclerotherapy and surgery in the treatment of greater varicose veins.
Interventions
PROCEDUREhigh ligation and stripping (surgery)
surgery consisting of high ligation in combination with long saphenous stripping
PROCEDUREFOAM
duplex guided foam sclerotherapy
Sponsors
ZonMw: The Netherlands Organisation for Health Research and Development
Maastricht University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* incompetence of great saphenous vein for minimal 20 cm * life expectancy at least 3 years * open and competent deep venous system * willing to undergo both treatments
Exclusion criteria
* active ulcer * signs of deep venous thrombosis with duplex * incompetence of the deep venous system
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| cumulative probability of recurrent varicose vein within 24 months after treatment | 24 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| quality of life (as measured by EuroQol-5D) | 24 months | — |
| patient preferences (as measured by conjoint analysis) | 24 months | — |
| direct Health care costs | 24 months | materials, operation costs, personnel costs |
Countries
Netherlands
Outcome results
None listed