This trial is active, not recruiting.

Conditions varicose veins, venous insufficiency, venous ulceration
Treatments surgery - saphenofemoral ligation, saphenous strip and avulsions, evlt
Sponsor University of Hull
Collaborator Hull and East Yorkshire Hospitals NHS Trust
Start date March 2004
End date August 2009
Trial size 260 participants
Trial identifier NCT00759434, HELP1


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
surgery - saphenofemoral ligation, saphenous strip and avulsions
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.

Primary Outcomes

Generic Quality of life - Short Form-36
time frame: 1 week, 6 weeks, 3 months, 1 year, 2 years

Secondary Outcomes

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
time frame: 1 week, 6 weeks, 3 months, 1 year, 2 years
Cost Effectiveness
time frame: 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Primary, symptomatic, varicose veins. - Isolated Saphenofemoral junction (SFJ) incompetence leading to long saphenous (LSV) reflux on duplex ultrasound. - LSV of 4mm diameter at the knee. - Ability to give informed written consent. Exclusion Criteria: - Inability to give informed written consent. - Symptomatic or complicated varicose veins not attributable to SFJ/LSV reflux. - Evidence of deep venous reflux on duplex scan.

Additional Information

Official title A Dual Centre, Randomised Controlled Trial of the Clinical and Cost Effectiveness of Endovenous Laser Therapy (EVLT) in the Treatment of Varicose Veins and Venous Ulcers
Principal investigator Ian C Chetter, MBChB
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by University of Hull.