Varicose Veins MedDRA version: 9.1 Level: LLT Classification code 10047013 Term: Varicose veins of lower extremities
Conditions
Interventions
Trade Name: Fibro-vein
Product Name: Fibro-vein
Pharmaceutical Form: Solution for injection
Sponsors
University of Aberdeen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult patients (aged over 18 years old) who are referred to the surgical out-patient department for treatment of primary varicose veins with symptomatic (CEAP grade 2 or above) primary long or short saphenous main stem incompetence (reflux >1 second on duplex scanning) are eligible for inclusion. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Current deep vein thrombosis, acute superficial vein thrombosis, allergy to sclerosant, pregnancy or breast feeding, history of hypercoagulability, arterial disease (ankle brachial pressure index <0.8), inability to mobilise post-procedure, needle phobia, long or short saphenous vein less than 3mm in diameter or greater than 15mm and tortuous veins that are considered to be unsuitable for EVLA due to difficulties in passing the guide wire, inability to provide informed consent, inability to complete study questionnaires. Other exclusion criteria include those specifically mentioned on the fibro-vein (sodium tetradecyl sulphate) prescribing information leaflet which are: varicosities caused by pelvic or abdominal tumours, cardiac failure, pulmonary oedema, local or systemic infection. All varicose vein treatment should be used with care in patients taking oral contraceptives or hormonal replacement therapy. The treating surgeon will either ask the patient to discontinue the oral contraceptive or hormonal replacement therapy prior to treatment or will prescribe heparin prophylaxis therapy. Patients who are not fit for a general anaesthetic due to significant systemic disease, morbid obesity or other causes will be excluded from the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the clinical and cost-effectiveness of conventional surgery with two minimally invasive treatment modalities (a) foam sclerotherapy alone of main long or short saphenous trunk and non-trunk varicosities and (b) Endovenous laser ablation (EVLA) of main trunk including foam sclerotherapy of non-trunk varicosities, if required, performed under local anaesthetic in respect of quality of life for each intervention at 6 months (and ultimately through to 5 years) and cost-effectiveness as cost per quality adjusted life year (QALY) gained; Secondary Objective: To compare the two novel interventions against conventional surgery in respect of: (i) Clinical success as determined by residual varicose veins, complication rates and return to normal activities. (ii) Technical success (duplex scan verified partial or complete ablation of, or the presence of reflux in, the main long or short saphenous trunk veins) at 6 months (and ultimately through to 5 years). In addition, any development of deep venous incompetence and neovascularisation up to 5 years. (iii) Cost to the health service and patients of each intervention and any subsequent care. ; Primary end point(s): We will assess outcomes up to 6 months, but with possible long-term follow-up to 5 years through a separate funding application. 1. Primary patient outcome: Disease specific (Aberdeen Varicose Vein Questionnaire) and generic quality of life (EQ-5D, SF-36) at 6 months 2. Primary economic outcome: Incremental cost per quality adjusted life years (QALY) at 6 months | — |
Countries
United Kingdom
Outcome results
None listed