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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
280
Patients undergo Saphenofemoral ligation, inversion stripping of the Long Saphenous Vein and avulsion of varicosities if necessary under a general anaesthetic.
Patients undergo endovenous laser treatment, using a 810nm laser aiming to occlude the incompetent long saphenous vein from the saphenofemoral junction to the knee. This may then be followed by ambulatory phlebectomy as appropriate. All procedures are to be performed under a local anaesthetic.
Hull Royal Infirmary
Hull, East Yorkshire, United Kingdom
Generic Quality of life - Short Form-36
Time frame: 1 week, 6 weeks, 3 months, 1 year, 2 years
Disease Specific quality of life - Aberdeen Varicose Vein Questionnaire
Time frame: 1 week, 6 weeks, 3 months, 1 year, 2 years
Generic quality of life - EuroQol
Time frame: 1 week, 6 weeks, 3 months, 1 year, 2 years
Venous Clinical Severity Score
Time frame: 3 months, 1 year, 2 years
Visual analogue pain scores
Time frame: 1 week
Return to work and normal functioning
Time frame: 1 week, 6 weeks
Would undergo EVLT again if necessary
Time frame: 1 week, 6 weeks, 3 months, 1 year, 2 years
Complication rates
Time frame: 1 week, 6 weeks, 3 months, 1 year, 2 years
Duplex and clinical assessment
A detailed clinical and duplex ultrasound assessment was undertaken to identify: The presence of residual or recurrent varicose veins (defined as clinically evident varicose veins of greater than 3mm in diameter present at 1 and 6 weeks (residual) or becoming evident only after 6 weeks (recurrent). This was irrespective of the presence or absence of symptoms. The pattern of underlying insufficiency on duplex giving rise to any clinically evident varicose veins or skin changes.
Time frame: 1 week, 6 weeks, 3 months, 1 year, 2 years
Cost Effectiveness
Time frame: 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.