Endovenous Laser Therapy (EVLT) for Sapheno-Popliteal Incompetence and Short Saphenous Vein (SSV) Reflux: A RCT
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|ClinicalTrials.gov Identifier: NCT00841178|
Recruitment Status : Active, not recruiting
First Posted : February 11, 2009
Last Update Posted : July 26, 2019
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|
|Venous Insufficiency Varicose Veins||Procedure: Surgery Procedure: EVLT||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||106 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||October 2005|
|Actual Primary Completion Date :||August 2011|
|Estimated Study Completion Date :||August 2022|
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
- 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 assessment [ Time Frame: 1 week, 6 weeks, 3 months, 1 year, 2 years ]
- Cost Effectiveness [ Time Frame: 2 years ]
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 ClinicalTrials.gov identifier (NCT number): NCT00841178
|Hull Royal Infirmary|
|Hull, East Yorkshire, United Kingdom, HU3 2JZ|
|Principal Investigator:||Ian C Chetter, MBChB||University of Hull|