Endovenous Laser Therapy (EVLT) for Sapheno-Popliteal Incompetence and Short Saphenous Vein (SSV) Reflux: A RCT

Study Overview
=================
Brief Summary
-----------------
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.

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

Conditions
-----------------
Venous Insufficiency, Varicose Veins

Intervention / Treatment
-----------------
* Procedure: Surgery
* Procedure: EVLT


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Surgery<br>Patients undergo Surgery under a general anaesthetic. | Procedure: Surgery<br>* Saphenopopliteal junction ligation, stripping of the Short Saphenous vein where possible, perforator ligation and ambulatory phlebectomy, where necessary.<br>* Other names: Crossectomy;|
| Experimental: EVLT<br>Patients undergo EVLT under a local anaesthetic. | Procedure: EVLT<br>* EVLT of the Short saphenous vein with perforator ligation and / or ambulatory phlebectomy as required.<br>* Other names: Endovenous Laser therapy, Endovenous Laser Ablation, EVLA;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Generic Quality of Life - Short Form-36 |  | 1 Week,, 6 Weeks, 3 Months, 1 Year, 2 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Specific Quality of Life - Aberdeen Varicose Vein Questionnaire |  | 1 Week, 6 Weeks, 3 Months, 1 Year, 2 Years | 
| Generic quality of life - EuroQol |  | 1 week, 6 weeks, 3 months, 1 year, 2 years | 
| Venous Clinical Severity Score |  | 3 months, 1 year, 2 years | 
| Visual analogue pain scores |  | 1 week | 
| Return to work and normal functioning |  | 1 week, 6 weeks | 
| Would undergo EVLT again if necessary |  | 1 week, 6 weeks, 3 months, 1 year, 2 years | 
| Complication rates |  | 1 week, 6 weeks, 3 months, 1 year, 2 years | 
| Duplex assessment |  | 1 week, 6 weeks, 3 months, 1 year, 2 years | 
| Cost Effectiveness |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Randomised controlled trial, Venous insufficiency, Varicose veins, Quality of Life, Clinical effectiveness, Cost effectiveness