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11 February 2012
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| [ Print-friendly version ] |
| Endovenous laser therapy (EVLT) versus ultrasound guided foam sclerotherapy (UGFS) for the treatment of varicose veins |
| ISRCTN | ISRCTN03080206 |
| ClinicalTrials.gov identifier | |
| Public title | Endovenous laser therapy (EVLT) versus ultrasound guided foam sclerotherapy (UGFS) for the treatment of varicose veins |
| Scientific title | Randomised controlled trial of endovenous laser therapy (EVLT) versus ultrasound guided foam sclerotherapy (UGFS) for the treatment of varicose veins |
| Acronym | N/A |
| Serial number at source | 08/H0710/78 |
| Study hypothesis | Patient recovery, quality of life, post-procedural pain and the direct medical costs of treatment are significantly different between endovenous laser therapy (EVLT) and ultrasound guided foam sclerotherapy (UGFS). |
| Lay summary | |
| Ethics approval | Ealing and West London Research Ethics Committee approved on the 17th March 2009 |
| Study design | Single centre randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Chronic venous insufficiency |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/04/2009 |
| Anticipated end date | 31/03/2011 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 100 |
| Interventions |
Group 1: UGFS to the long saphenous vein
Group 2: EVLT to the long saphenous vein and concurrent local anaesthetic phlebectomies Total duration of treatment ranges from the primary procedure (1 day) to two further optional sessions, six weeks apart (3 months). Total duration of follow-up is three months after the last treatment session. |
| Primary outcome measure(s) |
1. Return to normal activities
2. Quality of life using the Aberdeen Varicose Vein Questionnaire All outcomes will be assessed prior to the procedure (Day 0), at three weeks, then after optional adjuvant UGFS sessions and finally after a further three months. Air plethysmography will only be carried out before treatment and three months after the last treatment session. |
| Secondary outcome measure(s) |
1. Direct medical costs
2. Number of treatment sessions 3. Incidence of side-effects and complications 4. Effectiveness of treatment using duplex and air plethysmography 5. Post-procedural pain scores using a visual analogue scale 6. Change in clinical severity using the venous clinical severity scoring system All outcomes will be assessed prior to the procedure (Day 0), at three weeks, then after optional adjuvant UGFS sessions and finally after a further three months. Air plethysmography will only be carried out before treatment and three months after the last treatment session. |
| Sources of funding |
1. Ealing Hospital NHS Trust (UK) - Research and Development department
2. STD Pharmaceuticals Ltd (UK) |
| Trial website | |
| Publications | |
| Contact name | Mr George Geroulakos |
| Address |
Consultant Vascular Surgeon and Senior Lecturer
Ealing Hospital Uxbridge Road Southall |
| City/town | Middlesex |
| Zip/Postcode | UB1 3HW |
| Country | United Kingdom |
| g.geroulakos@imperial.ac.uk | |
| Sponsor | Ealing Hospital NHS Trust (UK) |
| Address |
Research and Development Office
Pasteur Suite, 8th Floor Uxbridge Road Southall |
| City/town | Middlesex |
| Zip/Postcode | UB1 3HW |
| Country | United Kingdom |
| gay.bineham@eht.nhs.uk | |
| Sponsor website: | http://www.ealinghospital.nhs.uk/ |
| Date applied | 21/01/2010 |
| Last edited | 04/02/2010 |
| Date ISRCTN assigned | 04/02/2010 |
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| © 2012 ISRCTN unless otherwise stated. | |
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