Insufficiency of Great Saphenous Vein, Varicose Veins
Conditions
Brief summary
A clinical randomized controlled trial, comparing 2 endovenous laser ablation (EVLA) techniques in patients with insufficiency of the great saphenous vein (GSV). There are multiple EVLA devices available, with different wavelengths. In the Netherlands, 940 nm Diode and 1470 nm Nd:Yag laser are the most frequently used devices. Both devices also proven to be equally effective in occluding the GSV. However, little is known about differences in patient-related outcomes. Therefore, the primary outcomes of this comparative clinical trial of 940 nm and 1470 nm EVLA, are pain scores, patient satisfaction and scores of health related and varicose-specific questionnaires. The secondary outcomes are complications and effectiveness of the treatment. It is thought that possibly the 1470 nm ELVA will give lower pain scores and higher patient satisfaction than 940 nm EVLA. No differences are expected in complication rate and effectiveness between the two treatments.
Detailed description
\* Study type: Interventional. Randomized comparative clinical trial.. * Outcome measures: * Primary study outcomes: Patient reported outcomes: 1. Pain score and use of painkillers, assessed with a numeric rating scale (NRS) of pain. 2. Treatment satisfaction, assessed with a NRS of satisfaction. 3. Health related quality of life, assessed with Dutch translated Aberdeen Varicose Vein Questionnaire (AVVQ) and EQ-5D questionnaire. * Secondary study outcomes: 1. Number of patients with adverse events. Major complications: deep and superficial venous thrombosis (embolic events), nerve injury, skin burns, and (sub)cutaneous infections. Minor complications: ecchymosis and hyperpigmentation. 2. Obliteration of varicose vein and/or absence of reflux (\> 0.5 sec. of retrograde flow) along the treated segment of the GSV. This is measured using US examination. * Outcome measures time frame: Follow-up of one year, with outcome measures at baseline, 1 week, 3 months and 1 year post treatment. \* Focus of the study: Varicose great saphenous veins (GSV) * Intervention information: * Intervention name: endovenous laser ablation (EVLA) * Intervention type: 1. EVLA with 940 nm Diode laser 2. EVLA with 1470 nm Nd:Yag laser * Arm information: both interventions are active comparators. * Locations: Rotterdam, Zuid-Holland, The Netherlands
Interventions
PROCEDUREEndovenous laser ablation (EVLA)
EVLA with 940 nm Diode laser EVLA with 1470 nm Nd:Yag laser With both devices, obliteration of the varicose vein is obtained by heating the vein, using emission of laser light.
Sponsors
Erasmus Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients over 18 years old * Insufficiency of the GSV measured with ultrasound imaging, reflux \> 0.5 sec, and diameter of vein \> 0.5 cm * Symptoms of chronic venous insufficiency, including complaints related to varicose veins (≥ C2) * No prior treatment of the insufficient GSV * Informed consent
Exclusion criteria
* Acute deep or superficial vein thrombosis * Agenesis of deep vein system * Vascular malformation or syndrome * Post-thrombotic syndrome, occlusive type * Pregnancy * Immobility * Allergy to lidocaine * Arterial insufficiency * Diameter of GSV ≤ 0.5 mm at puncture site
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain score and use of painkillers | 1 week post treatment | A questionnaire including a numeric rating scale (NRS) of pain is filled in by the patient. |
| Treatment satisfaction | 1 week post treatment | A NRS of satisfaction is filled in by the patient. |
| Health related quality of life | 0 and 12 weeks post treatment | Dutch Translated Aberdeen Varicose Vein Questionnaire (AVVQ) and EQ-5D questionnaire are filled in by the patient. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events | The adverse events will be assessed at 1 and 12 weeks post treatment. | Minor complications: ecchymoses and hyperpigmentation. Major complications: deep and superficial venous thrombosis (embolic events), nerve injury, skin burns, and (sub)cutaneous infections. |
| Occlusion of the treated GSV (effectiveness) | The rates will be compared between 940 nm and 1470 nm endovenous laser at time 1, 12 and 52 weeks post treatment. | Obliteration of varicose vein and/or absence of reflux (\>0.5 sec. of retrograde flow) along the treated segment of the GSV. This is measured using US examination. |
Countries
Netherlands
Outcome results
None listed