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Is laser treatment or surgery the best way of treating varicose veins?
ISRCTN ISRCTN99270116
DOI 10.1186/ISRCTN99270116
ClinicalTrials.gov identifier
EudraCT number
Public title Is laser treatment or surgery the best way of treating varicose veins?
Scientific title
Acronym N/A
Serial number at source VS03/2281
Study hypothesis 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.
Lay summary
Ethics approval Received from Leeds (West) Research Ethics Committee in May 2003 (ref: 03/052).
Study design Parallel group, non-blinded, randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Varicose veins
Participants - inclusion criteria 1. Symptomatic varicose veins
2. Primary sapheno-femoral incompetence with greater saphenous vein reflux
Participants - exclusion criteria 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
Anticipated start date 05/06/2003
Anticipated end date 01/12/2006
Status of trial Completed
Patient information material
Target number of participants 342
Interventions Endovenous laser treatment (810 nm diode laser, Diomed) versus sapheno-femoral ligation, greater saphenous vein stripping and avulsions (surgery).
Primary outcome measure(s) 1. Abolition of GSV reflux at three months (duplex ultrasound)
2. Improvement in disease-specific quality of life (Aberdeen Varicose Vein Questionnaire)
Secondary outcome measure(s) 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
Sources of funding 1. Leeds Teaching Hospitals NHS Trust (UK)
2. Diomed Ltd (UK) - part of research fellow salary paid (£15,000 pa)
Trial website
Publications Results in http://www.ncbi.nlm.nih.gov/pubmed/18278775
Contact name Mr  Michael  Gough
  Address Leeds Vascular Institute
The General Infirmary at Leeds
Great George Street
  City/town Leeds
  Zip/Postcode LS1 3EX
  Country United Kingdom
Sponsor Leeds Teaching Hospitals NHS Trust (UK)
  Address Leeds Vascular Institute
The General Infirmary at Leeds
Great George Street
  City/town Leeds
  Zip/Postcode LS1 3EX
  Country United Kingdom
  Sponsor website: http://www.leedsteachinghospitals.com/
Date applied 11/06/2007
Last edited 19/03/2008
Date ISRCTN assigned 10/07/2007
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