A New Method of Surgically Treating Varicose Veins and Venous Ulcers - a Study to Assess Clinical and Economic Value
|ClinicalTrials.gov Identifier: NCT00759434|
Recruitment Status : Unknown
Verified December 2014 by Daniel Carradice, University of Hull.
Recruitment status was: Active, not recruiting
First Posted : September 25, 2008
Last Update Posted : December 3, 2014
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||260 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||March 2004|
|Actual Primary Completion Date :||August 2009|
|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.
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.
- Generic Quality of life - Short Form-36 [ Time Frame: 1 week, 6 weeks, 3 months, 1 year, 2 years ]
- 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 ]
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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00759434
|Hull Royal Infirmary|
|Hull, East Yorkshire, United Kingdom, HU3 2JZ|
|Principal Investigator:||Ian C Chetter, MBChB||University of Hull|