Assessment of cost-effectiveness of the treatment of varicose veins
| ISRCTN | ISRCTN32956054 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32956054 |
| Secondary identifying numbers | HTA 95/05/06 |
- Submission date
- 25/04/2003
- Registration date
- 25/04/2003
- Last edited
- 08/11/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Jonathan Michaels
Scientific
Scientific
Department of Vascular Surgery
Sheffield Vascular Institute
Northern General Hospital
Herries Road
Sheffield
S5 7AU
United Kingdom
| Phone | +44 (0)114 2269124 |
|---|---|
| jonathan.michaels@sth.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | Assessment of cost-effectiveness of the treatment of varicose veins |
| Study acronym | REACTIV |
| Study objectives | 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. |
| Ethics approval(s) | Added as of 25/07/2007: Ethical approval for the study was obtained from both Sheffield and Exeter Local Research Ethics Committees. |
| Health condition(s) or problem(s) studied | Varicose veins/ulcers |
| Intervention | 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 |
| Intervention type | Other |
| Primary outcome measure | 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 measures | 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. |
| Overall study start date | 01/10/1998 |
| Completion date | 30/09/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 1,009 |
| Key inclusion criteria | Patients undergoing treatment for varicose veins |
| Key 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 |
| Date of first enrolment | 01/10/1998 |
| Date of final enrolment | 30/09/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Vascular Surgery
Sheffield
S5 7AU
United Kingdom
S5 7AU
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
| Phone | +44 (0)1132 545 843 |
|---|---|
| Sheila.Greener@doh.gsi.gov.uk | |
| Website | http://www.dh.gov.uk/en/index.htm |
"ROR" |
https://ror.org/03sbpja79 |
Funders
Funder type
Government
NIHR Health Technology Assessment Programme - HTA (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | HTA monograph | 01/04/2006 | Yes | No |
Editorial Notes
08/11/2022: Internal review.
