The aim of this study is to report a collaborative, prospective Singaporean experience using the Endovenous Radio Frequency® (EVRF®) from F Care Systems (Belgian) for the treatment of primary great and short saphenous vein reflux.
The investigators wish to evaluate its safety, efficacy, and performance. Although it has been shown to be safe and efficacious in its initial trials, these studies have been limited to generally a caucasian-based population, where the vein size, anatomy and distribution of venous incompetence can be different from their asian counterparts. The study will evaluate the technical, anatomical and clinical performance of EVRF® performed on multiple truncal varicose veins, and without mandatory postoperative compression stockings of the GSV, SSV or AASV. The two primary endpoints for this evaluation are technical success at the time of the procedure, and anatomical success, reported as complete closure at 2-weeks, 3 months, 6 months and 12 months.
Study Type
OBSERVATIONAL
Enrollment
30
Questionnaires to assess the quality of life (EQ-5D, CVVQ, CIVIQ, AVVQ, Patient satisfaction survey)
Singapre General Hospital
Singapore, Singaopore, Singapore
RECRUITINGTechnical Success at time of procedure
Occlusion of treated vein post-procedure
Time frame: Immediately post-procedure
Anatomical Success
Anatomical success defined as occlusion of treated vessel, as determined by duplex ultrasound.
Time frame: 2 weeks to 12 months post-procedure
Quality of Life Score using the EQ-5D questionnaire
EQ5D is used to assess quality of life based on Mobility, Self-Care, Usual Activities, Pain/Discomfort and Anxiety, rated at 5 levels: no problems, slight problems, moderate problems, severe problems, unable to perform activity. Inputs from this questionnaire is used to observe for changes in quality of life overtime.
Time frame: 2 weeks, 3 months, 6 months, 12 months post-procedure
Quality of Life Score using the Chronic Venous Insufficiency Questionnaire (CIVIQ)
CIVIQ is a questionnaire based on three dimensions - pain, physical and psychological, based on a scale from 1 to 5 (no trouble, slight, moderate, considerable, severe). Based on inputs, Global Index Score (GIS) will be tabulated, ranging for 0 to 100 - the higher the value, the poorer the quality of life.
Time frame: 2 weeks, 3 months, 6 months, 12 months post-procedure
Quality of Life score using the Aberdeen Varicose Vein Questionnaire (AVVQ)
To measure health status of varicose veins patients based on symptoms and impact on daily activities. A total score ranging from 0 to 100 will be tabulated, with 100 being worst quality of life
Time frame: 2 weeks, 3 months, 6 months, 12 months post-procedure
Clinical Change using Venous Clinical Severity Score (VCSS)
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VCSS evaluates the severity of hallmarks of venous disease - 0 (none), 1 (mild), 2 (moderate), 3 (severe).
Time frame: 2 weeks, 3 months, 6 months, 12 months post-procedure
Pain Score
Using a numerical rating scale, which ranges from 0 (no pain) to 10 (severe pain)
Time frame: First 10 days post-operation
Time taken to return to work and normal activities
Time frame: 10 days post-operation
Occlusion rates
Duplex ultrasound performed at specific timepoints to ensure that treated vein is occluded
Time frame: 2 weeks, 3 months, 6 months, 12 months post-procedure
Patient satisfaction with treatment: survey
A short survey to assess patient satisfaction and if there are any observed improvement in terms of appearance and symptoms post-procedure.
Time frame: 2 weeks, 3 months, 6 months, 12 months post-procedure