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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00759434
Recruitment Status : Completed
First Posted : September 25, 2008
Last Update Posted : July 24, 2019
University of Hull
Information provided by (Responsible Party):
Hull University Teaching Hospitals NHS Trust

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.

Condition or disease Intervention/treatment Phase
Varicose Veins Venous Insufficiency Venous Ulceration Procedure: Surgery - Saphenofemoral ligation, saphenous strip and avulsions Procedure: EVLT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 2004
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Varicose Veins

Arm Intervention/treatment
Active Comparator: Surgery Procedure: 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.

Experimental: EVLT Procedure: EVLT
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 Outcome Measures :
  1. Generic Quality of life - Short Form-36 [ Time Frame: 1 week, 6 weeks, 3 months, 1 year, 2 years ]

Secondary Outcome Measures :
  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 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00759434

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United Kingdom
Hull Royal Infirmary
Hull, East Yorkshire, United Kingdom, HU3 2JZ
Sponsors and Collaborators
Hull University Teaching Hospitals NHS Trust
University of Hull
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Principal Investigator: Ian C Chetter, MBChB University of Hull
Publications of Results:
Other Publications:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Hull University Teaching Hospitals NHS Trust Identifier: NCT00759434    
Other Study ID Numbers: HELP1
First Posted: September 25, 2008    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019
Keywords provided by Hull University Teaching Hospitals NHS Trust:
Varicose veins
Chronic venous insufficiency
Venous ulceration
Endovenous Laser
Additional relevant MeSH terms:
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Venous Insufficiency
Varicose Veins
Varicose Ulcer
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Pathologic Processes