Varicose veins, great saphenous vein, endovenous laser Circulatory System
Conditions
Interventions
Patients are randomized to one of three groups:
Group 1: receives EVLA with the 810 nm laser and a never touch fiber
Group 2: receives ELVeS with the 1470 nm laser using a bare fiber
Group 3: recei
Sponsors
Bergman Clinics (Netherlands)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age over 18 years 2. Patients with varicose veins stages C3-C6, Ep,AS3,Pr (according to CEAP classification criteria), with primary symptomatic unilateral varicose vein due to duplex documented reflux of the GSV 3. Duplex documented GSV criteria: refluxtime > 0.5s and GSV located in the saphenous compartment 4. Duplex documented endovenous procedure criteria: GSV diameter between 3 and 20 mm, absence of thrombus mass in the target vein
Exclusion criteria
Exclusion criteria: 1. Concomitant reflux of anterior accessory great saphenous vein (AAGSV), posterior accessory great saphenous vein (APGSV) and superficial accessory great saphenous vein (ASGSV) 2. GSV not located in the saphenous compartment 3. Extreme tortuosity 4. Patients with fibromyalgia and RA, active, and/or in the family 5. Pregnancy and breastfeeding 6. Documented deep venous thrombosis/pulmonary embolism 7. Previous surgical treatments
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary safety outcome: Pain: The patients registered an overall pain score on a visual analogue scale from 0 (no pain) to 100 (worst imaginable pain) for the first 14 days after treatment. The research nurse recorded the pain score and a statistician calculated the scores. Primary efficacy outcome: Abolition of reflux: Abolition of GSV reflux is confirmed by Duplex ultrasound. The diagnostic duplex criteria for abolition of reflux of the treated GSV segment. GSV is defined as the absence of retrograde flow lasting longer than 0.5 s on Duplex scanning. Measured at 6 weeks and at 3 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary safety outcomes: 1. Tightness: The patients registered a tightness score on a visual analogue scale from 0 (no pain) to 100 (worst imaginable tightness) for the first 14 days after treatment. The research nurse recorded the tightness score and a statistician calculated the scores. 2. Bruising/ecchymosis: The patients registered a bruising score on a visual analogue scale from 0 (no pain) to 100 (worst imaginable bruising) for the first 14 days after treatment. The research nurse recorded the bruising score and a statistician calculated the scores. 3. Work Productivity and Activity Impairment (WPAI) score: Work and activity outcomes were assessed using the Work Productivity and Activity Impairment GH questionnaire. All four domains of the WPAI questionnaire were assessed: 1. Absenteeism; 2. Presenteeism (reduction in productivity at work); 3. Overall work impairment; 4. Overall activity impairment. Measured at 14 days after treatment. 4. Deep vein thrombi (DVT)/pulmonary embolism (PE): All patients were requested to contact us if symptoms of DVT or PE developed. The diagnostic duplex criteria for thrombosis were abnormal or lack of vessel wall compressibility, intraluminal thrombus formation (mass) and absence of flow in the deep venous system. Secondary efficacy outcome: 1. Occlusion of the vein: Occlusion of the treated GSV vein segment is confirmed by Duplex ultrasound. The diagnostic duplex criteria for occlusion of the treated GSV is demonstrated by its complete occlusion or obliteration, confirmed by Duplex ultrasound. Measured at 6 weeks and 3 months. 2. Improvement in AVVVS (Aberdeen Varicose Vein Severity Score): a disease-specific quality of life measure, is recorded by the research fellow and calculated by a statistician. Measured at 6 weeks and 3 months. | — |
Countries
Netherlands
Outcome results
None listed