This trial is active, not recruiting.

Conditions venous insufficiency, varicose veins
Treatments surgery, evlt
Sponsor University of Hull
Collaborator Hull and East Yorkshire Hospitals NHS Trust
Start date October 2005
End date August 2011
Trial size 106 participants
Trial identifier NCT00841178, HELP 2


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)
Patients undergo Surgery under a general anaesthetic.
surgery Crossectomy
Saphenopopliteal junction ligation, stripping of the Short Saphenous vein where possible, perforator ligation and ambulatory phlebectomy, where necessary.
Patients undergo EVLT under a local anaesthetic.
evlt Endovenous Laser therapy, Endovenous Laser Ablation, EVLA
EVLT of the Short saphenous vein with perforator ligation and / or ambulatory phlebectomy as required.

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 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 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

Additional Information

Official title A Randomised Controlled Trial of the Clinical and Cost Effectiveness of Endovenous Laser Therapy in the Treatment of Varicose Veins Secondary to Isolated Sapheno-Popliteal Incompetence and Short Saphenous Reflux
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.