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ISRCTN
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ISRCTN99270116
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ClinicalTrials.gov identifier
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Public title
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Is laser treatment or surgery the best way of treating varicose veins?
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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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VS03/2281
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Study hypothesis
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Endovenous laser ablation (EVLA) produces comparable short-term results to surgery (abolition of great saphenous vein [GSV] reflux and improvement in symptoms) for the treatment of primary varicose veins due to sapheno-femoral incompetence with greater saphenous vein reflux.
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Ethics approval
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Received from Leeds (West) Research Ethics Committee in May 2003 (ref: 03/052).
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Study design
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Parallel group, non-blinded, randomised controlled trial
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Countries of recruitment
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United Kingdom
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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. Symptomatic varicose veins
2. Primary sapheno-femoral incompetence with greater saphenous vein reflux
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Participants - exclusion criteria
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1. Unable to consent
2. Children (under 18 years)
3. Unfit for general anaesthesia
4. Recurrent varicose veins
5. Patients on long-term anticoagulation
6. Patients with anterior thigh branch of greater saphenous vein arising within 10 cm of groin and competent GSV distal to this
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Anticipated start date
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05/06/2003
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Anticipated end date
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01/12/2006
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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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342
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Interventions
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Endovenous laser treatment (810 nm diode laser, Diomed) versus sapheno-femoral ligation, greater saphenous vein stripping and avulsions (surgery).
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Primary outcome measure(s)
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1. Abolition of GSV reflux at three months (duplex ultrasound)
2. Improvement in disease-specific quality of life (Aberdeen Varicose Vein Questionnaire)
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Secondary outcome measure(s)
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1. Time to return to work and to normal activity
2. Pain and analgesia use during first week following treatment
3. Overall satisfaction and satisfaction with cosmetic outcome
4. Generic quality of life (36-item Short Form health survey [SF-36]) at 1 and 12 weeks following treatment
5. Complications
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Sources of funding
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1. Leeds Teaching Hospitals NHS Trust (UK)
2. Diomed Ltd (UK) - part of research fellow salary paid (£15,000 pa)
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Trial website
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Publications
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Results in http://www.ncbi.nlm.nih.gov/pubmed/18278775
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Contact name
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Mr
Michael
Gough
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Address
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Leeds Vascular Institute
The General Infirmary at Leeds
Great George Street
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City/town
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Leeds
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Zip/Postcode
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LS1 3EX
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Country
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United Kingdom
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Sponsor
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Leeds Teaching Hospitals NHS Trust (UK)
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Address
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Leeds Vascular Institute
The General Infirmary at Leeds
Great George Street
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City/town
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Leeds
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Zip/Postcode
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LS1 3EX
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Country
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United Kingdom
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Sponsor website:
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http://www.leedsteachinghospitals.com/
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Date applied
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11/06/2007
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Last edited
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19/03/2008
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Date ISRCTN assigned
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10/07/2007
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