Endovenous Laser Therapy (EVLT) for Sapheno-Popliteal Incompetence and Short Saphenous Vein (SSV) Reflux: A RCT
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Generic Quality of Life - Short Form-36 [ Time Frame: 1 Week,, 6 Weeks, 3 Months, 1 Year, 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 ]
|Study Start Date:||October 2005|
|Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
Active Comparator: Surgery
Patients undergo Surgery under a general anaesthetic.
Saphenopopliteal junction ligation, stripping of the Short Saphenous vein where possible, perforator ligation and ambulatory phlebectomy, where necessary.
Other Name: Crossectomy
Patients undergo EVLT under a local anaesthetic.
EVLT of the Short saphenous vein with perforator ligation and / or ambulatory phlebectomy as required.
Other Name: Endovenous Laser therapy, Endovenous Laser Ablation, EVLA
Please refer to this study by its ClinicalTrials.gov identifier: NCT00841178
|Hull Royal Infirmary|
|Hull, East Yorkshire, United Kingdom, HU3 2JZ|
|Principal Investigator:||Ian C Chetter, MBChB||University of Hull|