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ISRCTN
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ISRCTN60300873
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ClinicalTrials.gov identifier
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Public title
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Randomised clinical trial comparing endovenous laser ablation of the great saphenous vein with and without ligation of the saphenofemoral junction, with a two-year follow-up
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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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Is high ligation after endovenous laser ablation better than endovenous laser alone?
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Ethics approval
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Ethics approval received from the Regional Ethics Committee of the Mesos Medical Centre, Utrecht (The Netherlands) 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 bilateral varicose veins
2. Clinical, aetiological, anatomical, pathological elements (CEAP) clinical class C2 venous disease
3. Informed written consent
4. Aged 20 - 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 scanning
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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 venous disease
4. Deep vein relux
5. Reflux in below knee perforator veins
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Anticipated start date
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01/03/2003
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Anticipated end date
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01/04/2005
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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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43
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Interventions
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Forty-three symptomatic patients with bilateral varicose veins were studied in which one side was randomly assigned to receive endovenous laser without saphenofemoral junction (SFJ) ligation, whereas the other side received endovenous laser with SFJ ligation.
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Primary outcome measure(s)
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Freedom from recurrent varicose veins in the groin, as confirmed by duplex ultrasound, two years after treatment.
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Secondary outcome measure(s)
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The following were assessed at 6, 12 and 24 months:
1. Abolition of reflux in the GSV
2. Venous Clinical Severity Score (VCSS)
3. Freedom from overall recurrent varicose veins
4. Procedural complications, including pain, bruising, saphenous nerve paraesthesia, tightness, superficial thrombophlebitis, skin burns, thrombotic events, and wounds
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Sources of funding
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The Mesos Medical Centre (Mesos Medisch Centrum) (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) (The Netherlands)
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Address
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c/o Mr Ben Disselhoff
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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Date applied
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14/03/2008
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Last edited
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02/04/2008
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Date ISRCTN assigned
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31/03/2008
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