Varicose veins of lower limbs Circulatory System Varicose veins of lower extremities
Conditions
Interventions
1. Radiofrequency ablation
2. Conventional saphenofemoral disconnetion and stripping
Both procedures are to be performed under general anaesthetic during a single operation. Based on their allocatio
Sponsors
VNUS Medical Technologies UK Ltd (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged 18 - 70 years, both sexes 2. Varicose veins due to isolated long saphenous vein incompetence proven on duplex scan 3. Requiring surgery 4. Long saphenous vein suitable for radiofrequency ablation
Exclusion criteria
Exclusion criteria: 1. Associated short saphenous and deep vein incompetence 2. Pregnancy 3. Patients with pacemaker or defibrillator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Elimination of long saphenous vein reflux and elimination of truncal varicosities. Measurement of outcomes will be carried out at the end of one week, six weeks, one year and five years. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to return to normal activities and work 2. Quality of life, estimated using Aberdeen Varicose Vein Questionnaire, Venous Insufficiency Epidemiologic and Economic Study of Quality-of-Life and Symptoms (VEINES-QOL/Sym) questionnaire, 36-item short form health survey (SF-36) and EuroQOL-5D generic questionnaires Measurement of outcomes will be carried out at the end of one week, six weeks, one year and five years. | — |
Countries
United Kingdom
Outcome results
None listed