Venous Insufficiency, Varicose Veins
Conditions
Keywords
Randomised controlled trial, Venous insufficiency, Varicose veins, Quality of Life, Clinical effectiveness, Cost effectiveness
Brief summary
Varicose veins are a common problem, affecting up to a third of the western adult population. Most suffer with aching, discomfort, pruritis, and muscle cramps, whilst complications include oedema, eczema, lipodermatosclerosis, ulceration, phlebitis, and bleeding. This is known to have a significant negative effect on patient's quality of life (QoL). Surgery has been used for many years, but it is known that there is a temporary decline in QoL post-op. This was demonstrated in our pilot study. Surgery leads to painful and prolonged recovery in some patients and has the risks of infection, haematoma and nerve injury. Recurrence rates are known to be significant. Duplex of veins post surgery has demonstrated persistent reflux in 9-29% of cases at 1 year, 13-40% at 2 years, 40% at 5 years and 60% at 34 years. 26% of NHS patients were 'very dissatisfied' with their varicose vein surgery. Newer, less invasive treatments are being developed. It would be advantageous to find a treatment that avoided the morbidity of surgery, one that could be performed as a day-case procedure under a local anaesthetic, a treatment that could offer lower recurrence rates and allow an early return to work. These should be the aims of any new treatment for varicose veins. Endovenous Laser Treatment (EVLT) is performed under a local anaesthetic and uses laser energy delivered into the vein to obliterate it. The vein therefore need not be tied off surgically and stripped out. The aim of this study is to compare the clinical, cost effectiveness and safety of Surgery and EVLT.
Interventions
PROCEDURESurgery
Saphenopopliteal junction ligation, stripping of the Short Saphenous vein where possible, perforator ligation and ambulatory phlebectomy, where necessary.
PROCEDUREEVLT
EVLT of the Short saphenous vein with perforator ligation and / or ambulatory phlebectomy as required.
Sponsors
University of Hull
Hull University Teaching Hospitals NHS Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Primary, symptomatic, varicose veins * Isolated Sapheno-popliteal (SPJ) incompetence, leading to reflux in the Short saphenous vein (SSV) on duplex ultrasound * SSV of 4mm distally * Ability to give informed written consent
Exclusion criteria
* Inability to give informed written consent * Symptomatic or complicated varicose veins not attributable to SPJ/SSV reflux * Evidence of deep venous reflux on duplex scan
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Generic Quality of Life - Short Form-36 | 1 Week,, 6 Weeks, 3 Months, 1 Year, 2 Years |
Secondary
| Measure | Time frame |
|---|---|
| Generic quality of life - EuroQol | 1 week, 6 weeks, 3 months, 1 year, 2 years |
| Venous Clinical Severity Score | 3 months, 1 year, 2 years |
| Visual analogue pain scores | 1 week |
| Return to work and normal functioning | 1 week, 6 weeks |
| Disease Specific Quality of Life - Aberdeen Varicose Vein Questionnaire | 1 Week, 6 Weeks, 3 Months, 1 Year, 2 Years |
| Complication rates | 1 week, 6 weeks, 3 months, 1 year, 2 years |
| Duplex assessment | 1 week, 6 weeks, 3 months, 1 year, 2 years |
| Cost Effectiveness | 2 years |
| Would undergo EVLT again if necessary | 1 week, 6 weeks, 3 months, 1 year, 2 years |
Countries
United Kingdom
Outcome results
None listed