A randomized comparative single center study of the treatment of the insufficient greater saphenous vein: crossectomy with short strip vs Ultrasound sclerocompression therapy (ESCT) vs endovasculair laser (EVLT). The Magna trial.
Recruiting
- Conditions
- chronic venous insufficiencyvaricose veins10057165
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 240
Inclusion Criteria
>18 years old
Objective GSV insufficiency (Ultrasound reflux >0.5 sec with diameter >0.49)
Non treated GSV varicosis
CEAP classification (C2, As2)
Informed consent
Exclusion Criteria
Acute deep and superficial venous thrombosis
Deep venous insufficiency
Agenesia deep venous system
Vasculair malformations / syndromes
Post thrombotic syndrome
pregnancy
heart failure
contra-indication for surgery
Immobility
Allergic reactions (lidocaine and/or polidocanol)
Arterial insufficiency
Use of anti-coagulation drugs
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primairy outcomes:<br /><br>1. Ultrasound:<br /><br>a. absence of GSV and/or absence of reflux of the GSV >0.5 sec at the crosse,<br /><br>mid upper leg and just distaal of the knee<br /><br>b. Degree of neovascularization (grade 1 to 3)<br /><br><br /><br>2. Clinical characteristics:<br /><br>a. using the CEAP classification<br /><br><br /><br>3. Additional treatments on the included GSV<br /><br>a. number of additional ESCT treatments after initial therapy</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary:<br /><br>1. Patient reported outcomes:<br /><br>a. Reduction of chronic venous insufficiency symptoms on VAS (0-100)<br /><br>b. Global treatrment satisfaction on VAS (0-100)<br /><br>c. Health related quality of life (EQ-5D and CIVIQ)<br /><br>d Adjusted Treatment Medication Satisfaction Questionnaire (TMSQ)<br /><br><br /><br>Tertiary:<br /><br>1. Adverse events</p><br>