Condition category
Circulatory System
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
01/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Jonathan Michaels

ORCID ID

Contact details

Department of Vascular Surgery
Sheffield Vascular Institute
Northern General Hospital
Herries Road
Sheffield
S5 7AU
United Kingdom
+44 (0)114 2269124
jonathan.michaels@sth.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 95/05/06

Study information

Scientific title

Acronym

REACTIV

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.

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/10/1998

Overall trial end date

30/09/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Patients undergoing treatment for varicose veins

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1,009

Participant 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

Recruitment start date

01/10/1998

Recruitment end date

30/09/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Vascular Surgery
Sheffield
S5 7AU
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/en/index.htm

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

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

Publication citations

  1. HTA monograph

    Michaels JA, Campbell WB, Brazier JE, Macintyre JB, Palfreyman SJ, Ratcliffe J, Rigby K, Randomised clinical trial, observational study and assessment of cost-effectiveness of the treatment of varicose veins (REACTIV trial)., Health Technol Assess, 2006, 10, 13, 1-196, iii-iv.

Additional files

Editorial Notes