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Assessment of cost-effectiveness of the treatment of varicose veins

Assessment of cost-effectiveness of the treatment of varicose veins

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN32956054
Enrollment
1009
Registered
2003-04-25
Start date
1998-10-01
Completion date
Unknown
Last updated
2022-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Varicose veins/ulcers Circulatory System

Interventions

Interventions updated as of 25/07/2007: Group 1 (34 patients): minor varicose veins with no reflux, randomised between conservative treatment and sclerotherapy Group 2

Sponsors

Department of Health (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026