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| [ Print-friendly version ] |
| Assessment of cost-effectiveness of the treatment of varicose veins |
| ISRCTN | ISRCTN32956054 |
| ClinicalTrials.gov identifier | |
| Public title | Assessment of cost-effectiveness of the treatment of varicose veins |
| Scientific title | |
| Acronym | REACTIV |
| Serial number at source | HTA 95/05/06 |
| Study hypothesis |
The project will assess the cost effectiveness of the commonly used treatments for Varicose Veins by way of Markov process decision model. The data for the modelling will be obtained through a combination if systematic literature review and the collection of retrospective and prospective data on patients undergoing treatment for varicose veins. This will include randomised controlled studies in three sub-groups of patients in whom conservative treatment, sclerotherapy and surgery will be compared.
The model will allow an assessment of the incremental cost effectiveness of each treatment modality in sub groups of patients based upon their symptomatic, investigative and demographic features. Patient and societal priorities for treatment will be assessed using a "willingness to pay" (WTP) technique. |
| Lay summary | |
| Ethics approval | Added as of 25/07/2007: Ethical approval for the study was obtained from both Sheffield and Exeter Local Research Ethics Committees. |
| Study design | Randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Varicose veins/ulcers |
| Participants - inclusion criteria | Patients undergoing treatment for varicose veins |
| Participants - 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 |
| Anticipated start date | 01/10/1998 |
| Anticipated end date | 30/09/2003 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 1,009 |
| 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 (77 patients): moderate varicose veins with reflux, randomised between surgery and sclerotherapy Group 3 (246 patients): severe varicose veins with reflux, randomised between conservative treatment and surgery The remaining 652 patients formed the observational part of the study. Interventions provided at time of registration: 1. Conservative treatment 2. Sclerotherapy 3. Surgery |
| Primary outcome measure(s) |
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 outcome measure(s) |
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. |
| Sources of funding | NIHR Health Technology Assessment Programme - HTA (UK) |
| Trial website | |
| Publications | 2006 HTA monograph in http://www.ncbi.nlm.nih.gov/pubmed/16707070 |
| Contact name | Mr Jonathan Michaels |
| Address |
Department of Vascular Surgery
Sheffield Vascular Institute Northern General Hospital Herries Road |
| City/town | Sheffield |
| Zip/Postcode | S5 7AU |
| Country | United Kingdom |
| Tel | +44 (0)114 2269124 |
| Fax | +44 (0)114 2610112 |
| jonathan.michaels@sth.nhs.uk | |
| Sponsor | Department of Health (UK) |
| Address |
Quarry House
Quarry Hill |
| City/town | Leeds |
| Zip/Postcode | LS2 7UE |
| Country | United Kingdom |
| Tel | +44 (0)1132 545 843 |
| Sheila.Greener@doh.gsi.gov.uk | |
| Sponsor website: | http://www.dh.gov.uk/en/index.htm |
| Date applied | 25/04/2003 |
| Last edited | 01/09/2009 |
| Date ISRCTN assigned | 25/04/2003 |
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