Varicose veins/ulcers Circulatory System
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients undergoing treatment for varicose veins
Exclusion criteria
Exclusion criteria: Added as of 25/07/2007: General exclusion criteria: 1. Unwillingness to give informed consent 2. Unwilling or unable to complete assessment protocol 3. Current evidence of thrombophlebitis, ulceration or DVT Specific exclusion criteria: Group 1 Sclerotherapy vs conservative treatment: 1. Patients with deep venous insufficiency confirmed by duplex 2. Allergy to sclerosant 3. Diameter of varicose veins >2 cm Group 2 Sclerotherapy vs surgery: 1. Patients with deep venous insufficiency confirmed by duplex 2. Allergy to sclerosant 3. Diameter of varicose veins >2 cm 4. Pre-existing co-morbidities that would make them unsuitable for surgery 5. BMI >32 Group 3 Surgery vs conservative treatment: 1. Patients with deep venous insufficiency confirmed by duplex 2. Allergy to sclerosant 3. Diameter of varicose veins >2 cm 4. Pre-existing co-morbidities that would make them unsuitable for surgery. 5. BMI >32
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome measures updated as of 25/07/2007: 1. Clinical effectiveness, as measured using the Short Form 6D (SF-6D) utility valuation 2. Cost-effectiveness analysis Primary outcome measures provided at time of registration: Cost-effectiveness of each treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Added as of 25/07/2007: 1. Complications of treatment 2. Symptomatic relief 3. Health-Related Quality of Life (HRQoL) and patient satisfaction. HRQoL was measured using the Short Form with 36 Items (SF-36), EuroQol quality of life questionnaire (EQ-5D) and standard gamble questionnaires. | — |
Countries
England, United Kingdom