Assessment of cost-effectiveness of the treatment of varicose veins

ISRCTN	ISRCTN32956054
DOI	https://doi.org/10.1186/ISRCTN32956054
Protocol serial number	HTA 95/05/06
Sponsor	Department of Health (UK)
Funder	NIHR Health Technology Assessment Programme - HTA (UK)

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

Department of Vascular Surgery
Sheffield Vascular Institute
Northern General Hospital
Herries Road
Sheffield
S5 7AU
United Kingdom

Phone	+44 (0)114 2269124
Email	jonathan.michaels@sth.nhs.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(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
Key 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.
Completion date	30/09/2003

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	1009
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

United Kingdom
England

Study participating centre

Department of Vascular Surgery

Sheffield
S5 7AU
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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.