Randomised controlled trial comparing foam sclerotherapy, alone or in combination with endovenous laser therapy, with conventional surgery as a treatment for varicose veins

Conditions

Varicose veins Circulatory System Varicose veins

Julie Brittenden, David Cooper, Maria Dimitrova, Graham Scotland, Seonaidh Cotton et al. (21 authors)

New England Journal of Medicine2019-09-04111 citations

Clinical effectiveness and cost-effectiveness of foam sclerotherapy, endovenous laser ablation and surgery for varicose veins: results from the Comparison of LAser, Surgery and foam Sclerotherapy (CLASS) randomised controlled trial.

Brittenden J, Cotton SC, Elders A, Tassie E, Scotland G, Ramsay CR, Norrie J, Burr J, Francis J, Wileman S, Campbell B, Bachoo P, Chetter I, Gough M, Earnshaw J, Lees T, Scott J, Baker SA, MacLennan G, Prior M, Bolsover D, Campbell MK.

2015-04-0156 citations

10.3310/hta19270

A Randomized Trial Comparing Treatments for Varicose Veins

Julie Brittenden, Seonaidh Cotton, Andrew Elders, Craig Ramsay, John Norrie et al. (19 authors)

New England Journal of Medicine2014-09-24210 citations

10.1056/nejmoa1400781

Interventions

Arm 1: Foam sclerotherapy Arm 2: Foam sclerotherapy + endovenous laser therapy Arm 3: Conventional surgery

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adult patients (aged over 18 years old) 2. Those who are referred to the surgical out-patient department for treatment of primary varicose veins with symptomatic (CEAP [Clinical, Etiological, Anatomical, Pathological elements] classification grade 2 or above) primary long or short saphenous main stem incompetence (reflux >1 second on duplex scanning) 3. Suitable for day case treatment

Exclusion criteria

Exclusion criteria: 1. Current deep vein thrombosis 2. Deep venous incompetence 3. Acute superficial vein thrombosis 4. Allergy to sclerosant 5. Pregnancy or breastfeeding 6. History of hypercoagulability 7. Arterial disease (ankle brachial pressure index <0.8) 8. Inability to mobilise post-procedure 9. Needle phobia 10. Long or short saphenous vein less than 3 mm in diameter or greater than 15 mm and tortuous veins that are considered to be unsuitable for endovenous laser ablation (EVLA) due to difficulties in passing the guide wire 11. Inability to complete study questionnaires

Design outcomes

Primary

Measure	Time frame
The following will be assessed at 6 months: Primary patient outcome: 1. Disease specific: Aberdeen Varicose Vein Questionnaire 2. Generic: EuroQol (EQ-5D), the 36-item Short Form health survey (SF-36) Primary economic outcome: 3. Incremental cost per quality adjusted life year (QALY)	—

Secondary

Measure	Time frame
1. Costs to the health service and patients and any subsequent care 2. Technical success of venous intervention at 6 weeks and 6 months 3. Clinical success of venous intervention at 6 weeks and 6 months 4. Disease-specific and generic quality of life at 6 weeks 5. Behavioural recovery	—

Countries

United Kingdom

Outcome results

None listed