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NCT Number: NCT00759434

A New Method of Surgically Treating Varicose Veins and Venous Ulcers - a Study to Assess Clinical and Economic Value

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.

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Key information

Conditions

Varicose Veins Cardiovascular Diseases Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Varicose Ulcer Vascular Diseases Venous Insufficiency Venous Ulceration

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hull Royal Infirmary

Hull, East Yorkshire, HU3 2JZ, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Surgery - Saphenofemoral ligation, saphenous strip and avulsions

Procedure

Patients undergo Saphenofemoral ligation, inversion stripping of the Long Saphenous Vein and avulsion of varicosities if necessary under a general anaesthetic.

EVLT

Procedure

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

  1. Generic Quality of life - Short Form-36

    Time frame: 1 week, 6 weeks, 3 months, 1 year, 2 years

Secondary outcomes

  1. Disease Specific quality of life - Aberdeen Varicose Vein Questionnaire

    Time frame: 1 week, 6 weeks, 3 months, 1 year, 2 years

  2. Generic quality of life - EuroQol

    Time frame: 1 week, 6 weeks, 3 months, 1 year, 2 years

  3. Venous Clinical Severity Score

    Time frame: 3 months, 1 year, 2 years

  4. Visual analogue pain scores

    Time frame: 1 week

  5. Return to work and normal functioning

    Time frame: 1 week, 6 weeks

  6. Would undergo EVLT again if necessary

    Time frame: 1 week, 6 weeks, 3 months, 1 year, 2 years

  7. Complication rates

    Time frame: 1 week, 6 weeks, 3 months, 1 year, 2 years

  8. Duplex and clinical assessment

    Time frame: 1 week, 6 weeks, 3 months, 1 year, 2 years

    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.

  9. Cost Effectiveness

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Hull University Teaching Hospitals NHS Trust

Other Gov

Collaborators

  • University of Hull

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Sep 25, 2008
Registry last updated
Aug 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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