Assessment of cost-effectiveness of the treatment of varicose veins

Not Applicable

Completed

• Conditions: Varicose veins/ulcers; Circulatory System

• Registration Number: ISRCTN32956054
• Lead Sponsor: Department of Health (UK)

Brief Summary

2006 Results article in http://www.ncbi.nlm.nih.gov/pubmed/16707070 HTA monograph

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2003-04-25
• Study Completion: 2003-09-30
• Last Update Posted: 21 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1009

Inclusion Criteria

Patients undergoing treatment for varicose veins

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Primary outcome measures updated as of 25/07/2007:<br> 1. Clinical effectiveness, as measured using the Short Form 6D (SF-6D) utility valuation<br> 2. Cost-effectiveness analysis<br><br> Primary outcome measures provided at time of registration:<br> Cost-effectiveness of each treatment<br>

Secondary Outcome Measures

Name	Time	Method
<br> Added as of 25/07/2007:<br> 1. Complications of treatment<br> 2. Symptomatic relief<br> 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.<br>