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ISRCTN
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ISRCTN33832691
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ClinicalTrials.gov identifier
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Public title
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Randomised clinical trial comparing endovenous laser ablation with cryostripping for varicose veins: two-year results
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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Study questions:
1. Is endovenous laser of the great saphenous vein clinically better than cryostripping?
2. Is endovenous laser of the great saphenous vein less expensive than cryostripping?
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Ethics approval
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Ethics approval received from the Regional Ethics Committee of the Mesos Medical Centre on the 15th March 2003.
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Study design
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Randomised controlled trial
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Countries of recruitment
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The Netherlands
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Disease/condition/study domain
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Varicose veins
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Participants - inclusion criteria
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1. Patients with primary symptomatic varicose veins
2. Clinical, aetiological, anatomical, pathological elements (CEAP) clinical class C2 venous disease
3. Informed written consent
4. Age 19 - 75 years
5. Great saphenous vein (GSV) incompetence from the groin to below the knee, defined as retrograde flow lasting longer than 0.5 seconds on duplex ultrasound imaging
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Participants - exclusion criteria
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1. Previous venous surgery
2. History of deep vein thrombosis (DVT)
3. C3-6 CEAP
4. Deep vein reflux
5. Anatomical duplication
6. Reflux in below-knee perforator veins
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Anticipated start date
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01/06/2003
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Anticipated end date
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01/07/2005
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Status of trial
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Completed
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Patient information material
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Target number of participants
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120
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Interventions
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Endovenous laser versus cryostripping.
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Primary outcome measure(s)
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The following were assessed at 6, 12 and 24 months:
1. Freedom from recurrence
2. Improvement in Venous Clinical Severity Score (VCSS)
3. Improvement in Aberdeen Varicose Vein Severity Score (AVVSS)
4. Improvement in the short form 6D (SF-6D), a single preference based measure of health, representing overall quality of life derived from the 36-item short form 36 (SF-36) questionnaires
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Secondary outcome measure(s)
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The following were assessed at 6, 12 and 24 months:
1. Operative time
2. Complications
3. Activity impairment
4. Quality-adjusted life years (QALY)
4. Patient satisfaction
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Sources of funding
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The Mesos Medical Centre (The Netherlands)
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Trial website
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Publications
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Contact name
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Mr
Ben
Disselhoff
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Address
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Burg s'Jacoblaan 56
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City/town
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Bussum
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Zip/Postcode
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1401 BS
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Country
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Netherlands
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Sponsor
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The Mesos Medical Centre (Mesos Medisch Centrum Utrecht) The Netherlands)
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Address
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c/o Mr Ben Disselhoff
Van Heuven Goedhartlaan 1
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City/town
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CE Utrecht
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Zip/Postcode
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3527
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Country
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Netherlands
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Sponsor website:
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http://www.mesos.nl
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Date applied
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14/03/2008
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Last edited
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31/03/2008
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Date ISRCTN assigned
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31/03/2008
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