- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00841178
Endovenous Laser Therapy (EVLT) for Sapheno-Popliteal Incompetence and Short Saphenous Vein (SSV) Reflux: A RCT
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
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
East Yorkshire
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Hull, East Yorkshire, United Kingdom, HU3 2JZ
- Hull Royal Infirmary
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Primary, symptomatic, varicose veins
- Isolated Sapheno-popliteal (SPJ) incompetence, leading to reflux in the Short saphenous vein (SSV) on duplex ultrasound
- SSV of 4mm distally
- Ability to give informed written consent
Exclusion Criteria:
- Inability to give informed written consent
- Symptomatic or complicated varicose veins not attributable to SPJ/SSV reflux
- Evidence of deep venous reflux on duplex scan
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Surgery
Patients undergo Surgery under a general anaesthetic.
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Saphenopopliteal junction ligation, stripping of the Short Saphenous vein where possible, perforator ligation and ambulatory phlebectomy, where necessary.
Other Names:
|
Experimental: EVLT
Patients undergo EVLT under a local anaesthetic.
|
EVLT of the Short saphenous vein with perforator ligation and / or ambulatory phlebectomy as required.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Generic Quality of Life - Short Form-36
Time Frame: 1 Week,, 6 Weeks, 3 Months, 1 Year, 2 Years
|
1 Week,, 6 Weeks, 3 Months, 1 Year, 2 Years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Disease Specific Quality of Life - Aberdeen Varicose Vein Questionnaire
Time Frame: 1 Week, 6 Weeks, 3 Months, 1 Year, 2 Years
|
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
|
1 week, 6 weeks, 3 months, 1 year, 2 years
|
Venous Clinical Severity Score
Time Frame: 3 months, 1 year, 2 years
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3 months, 1 year, 2 years
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Visual analogue pain scores
Time Frame: 1 week
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1 week
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Return to work and normal functioning
Time Frame: 1 week, 6 weeks
|
1 week, 6 weeks
|
Would undergo EVLT again if necessary
Time Frame: 1 week, 6 weeks, 3 months, 1 year, 2 years
|
1 week, 6 weeks, 3 months, 1 year, 2 years
|
Complication rates
Time Frame: 1 week, 6 weeks, 3 months, 1 year, 2 years
|
1 week, 6 weeks, 3 months, 1 year, 2 years
|
Duplex assessment
Time Frame: 1 week, 6 weeks, 3 months, 1 year, 2 years
|
1 week, 6 weeks, 3 months, 1 year, 2 years
|
Cost Effectiveness
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Ian C Chetter, MBChB, University of Hull
Publications and helpful links
General Publications
- Samuel N, Carradice D, Wallace T, Mekako A, Hatfield J, Chetter I. Randomized clinical trial of endovenous laser ablation versus conventional surgery for small saphenous varicose veins. Ann Surg. 2013 Mar;257(3):419-26. doi: 10.1097/SLA.0b013e318275f4e4.
- Carradice D, Mazari FA, Mekako A, Hatfield J, Allgar V, Chetter IC. Energy delivery during 810 nm endovenous laser ablation of varicose veins and post-procedural morbidity. Eur J Vasc Endovasc Surg. 2010 Sep;40(3):393-8. doi: 10.1016/j.ejvs.2010.04.010. Epub 2010 May 26.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HELP 2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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