GSV insufficiency varicose veins
Conditions
Interventions
Endovenous Laser Ablation or Steam Ablation. Both procedures are endovenous
techniques based on heating the varicose vein from inside reulting in closure
of the treated vein.
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: primary insufficiency of GSV patients over 18 years old symptoms of chronic venous insufficiency informed consent
Exclusion criteria
Exclusion criteria: agenesis of deep venous system acute deep or superficial vein thrombosis vascular malformation or syndrome post-thrombotic syndrome of occlusive type
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Obliteration of varicose vein and absence of reflux (>0.5 sec. of retrograde flow) along the treated segment of the GSV. This is measured using US examination. The rates will be compared between EVLA and SVS at time 12 and 52 weeks. 2. Varicose Vein Severity score (VVSS), (assessed with a questionnaire). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Treatment complications: a. Major complications: deep and superficial venous thrombosis (embolic events), nerve injury, skin burns, and (sub)cutaneous infections. b. Minor complications: ecchymosis, pain and hyperpigmentation. The rates will be compared between EVLA and Steam Ablation at time 2 and 12 weeks. 2. Patient reported outcomes: a. Health related quality of life will be measured using the Dutch Aberdeen Questionnaire. b. Treatment satisfaction will be assessed. c. Pain score. 3. Cost-effectiveness analysis (CEA): a. Direct and indirect costs associated with EVLA and Steam Ablation will be estimated. b. Quality adjusted life years will be assessed using the EQ-5D. | — |
Countries
Netherlands
Outcome results
None listed