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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Hull and East Yorkshire Hospitals NHS Trust
Information provided by (Responsible Party):
Daniel Carradice, University of Hull
ClinicalTrials.gov Identifier:
NCT00759434
First received: September 23, 2008
Last updated: June 18, 2013
Last verified: June 2013

September 23, 2008
June 18, 2013
March 2004
August 2009   (final data collection date for primary outcome measure)
Generic Quality of life - Short Form-36 [ Time Frame: 1 week, 6 weeks, 3 months, 1 year, 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00759434 on ClinicalTrials.gov Archive Site
  • Disease Specific quality of life - Aberdeen Varicose Vein Questionnaire [ Time Frame: 1 week, 6 weeks, 3 months, 1 year, 2 years ] [ Designated as safety issue: No ]
  • Generic quality of life - EuroQol [ Time Frame: 1 week, 6 weeks, 3 months, 1 year, 2 years ] [ Designated as safety issue: No ]
  • Venous Clinical Severity Score [ Time Frame: 3 months, 1 year, 2 years ] [ Designated as safety issue: No ]
  • Visual analogue pain scores [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Return to work and normal functioning [ Time Frame: 1 week, 6 weeks ] [ Designated as safety issue: No ]
  • Would undergo EVLT again if necessary [ Time Frame: 1 week, 6 weeks, 3 months, 1 year, 2 years ] [ Designated as safety issue: No ]
  • Complication rates [ Time Frame: 1 week, 6 weeks, 3 months, 1 year, 2 years ] [ Designated as safety issue: Yes ]
  • Duplex and clinical assessment [ Time Frame: 1 week, 6 weeks, 3 months, 1 year, 2 years ] [ Designated as safety issue: Yes ]

    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.

  • Cost Effectiveness [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Disease Specific quality of life - Aberdeen Varicose Vein Questionnaire [ Time Frame: 1 week, 6 weeks, 3 months, 1 year, 2 years ] [ Designated as safety issue: No ]
  • Generic quality of life - EuroQol [ Time Frame: 1 week, 6 weeks, 3 months, 1 year, 2 years ] [ Designated as safety issue: No ]
  • Venous Clinical Severity Score [ Time Frame: 3 months, 1 year, 2 years ] [ Designated as safety issue: No ]
  • Visual analogue pain scores [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Return to work and normal functioning [ Time Frame: 1 week, 6 weeks ] [ Designated as safety issue: No ]
  • Would undergo EVLT again if necessary [ Time Frame: 1 week, 6 weeks, 3 months, 1 year, 2 years ] [ Designated as safety issue: No ]
  • Complication rates [ Time Frame: 1 week, 6 weeks, 3 months, 1 year, 2 years ] [ Designated as safety issue: Yes ]
  • Duplex assessment [ Time Frame: 1 week, 6 weeks, 3 months, 1 year, 2 years ] [ Designated as safety issue: Yes ]
  • Cost Effectiveness [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A New Method of Surgically Treating Varicose Veins and Venous Ulcers - a Study to Assess Clinical and Economic Value
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

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Varicose Veins
  • Venous Insufficiency
  • Venous Ulceration
  • 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.
  • 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.
  • Active Comparator: Surgery
    Intervention: Procedure: Surgery - Saphenofemoral ligation, saphenous strip and avulsions
  • Experimental: EVLT
    Intervention: Procedure: EVLT

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
260
Not Provided
August 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00759434
HELP1
No
Daniel Carradice, University of Hull
University of Hull
Hull and East Yorkshire Hospitals NHS Trust
Principal Investigator: Ian C Chetter, MBChB University of Hull
University of Hull
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP