Endovenous laser therapy (EVLT) versus ultrasound-guided foam sclerotherapy (UGFS) for the treatment of varicose veins

Completed

Conditions: Chronic venous insufficiency
Circulatory System
Other disorders of veins

Registration Number: ISRCTN03080206

Lead Sponsor: Ealing Hospital NHS Trust (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 100

Inclusion Criteria

1. Adult patients (aged 18 years or over, either sex) with symptomatic primary varicose veins in the long saphenous distribution and reflux greater than 1 second on duplex scanning
2. Suitability for both techniques, foam and laser

Exclusion Criteria

1. Saphenopopliteal junction incompetence
2. Previous surgery for varicose veins
3. Previous sclerotherapy for varicose veins
4. Deep vein thrombosis, previous or current
5. Significant arterial disease (Ankle Brachial Pressure Index [ABPI] less than 0.8)
6. Active malignancy
7. Coagulopathy
8. Pregnancy
9. Known allergies to local anaesthetics or sclerosants

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Return to normal activities<br>2. Quality of life using the Aberdeen Varicose Vein Questionnaire<br><br>All outcomes will be assessed prior to the procedure (Day 0), at 3 weeks, then after optional adjuvant UGFS sessions and finally after a further 3 months. Air plethysmography will only be carried out before treatment and 3 months after the last treatment session.<br><br>Updated 17/06/2014: Outcomes will be assessed and air plethysmography will be carried out at 5 years after the last treatment session.

Secondary Outcome Measures

Name	Time	Method
1. Direct medical costs<br>2. Number of treatment sessions<br>3. Incidence of side-effects and complications<br>4. Effectiveness of treatment using duplex and air plethysmography<br>5. Post-procedural pain scores using a visual analogue scale<br>6. Change in clinical severity using the venous clinical severity scoring system<br><br>All outcomes will be assessed prior to the procedure (Day 0), at 3 weeks, then after optional adjuvant UGFS sessions and finally after a further 3 months. Air plethysmography will only be carried out before treatment and 3 months after the last treatment session.<br><br>Updated 17/06/2014: Outcomes will be assessed and air plethysmography will be carried out at 5 years after the last treatment session.