Chronic Venous Insufficiency, Varicose Veins, Venous Reflux
Conditions
Keywords
Endovenous Ablation
Brief summary
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.
Detailed description
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.
Interventions
OTHERQuestionnaires
Questionnaires to assess the quality of life (EQ-5D, CVVQ, CIVIQ, AVVQ, Patient satisfaction survey)
Sponsors
Singapore General Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to 90 Years
Inclusion criteria
1. Age \>21 years, able to understand the requirements of the study and provide informed consent. 2. C2 - C5 varicose veins / CVI 3. Symptomatic primaryGSV, SSV or AASV incompetence, with reflux \>0.5 seconds on colour duplex, including one or more of the following symptoms: aching, throbbing, heaviness, fatigue, pruritus, night cramps, restlessness, generalized pain or discomfort, swelling. 4. Patients who has GSV, SSV or AASV diameters of 3mm to 12mm in the standing position.
Exclusion criteria
1. Current DVT or history of DVT 2. Recurrent varicose veins 3. Pregnant patients 4. Arterial disease (ABPI\<0.8) 5. Sepsis 6. Patients who are unwilling to participate 7. Inability or unwillingness to complete questionnaires 8. Adverse reaction to sclerosant or cyanoacrylate 9. GSV, SSV or AASV severely tortuous 10. Life expectancy \< 1 year 11. Active treatment for malignancy other than non-melanoma skin cancer 12. Current, regular use of systemic anticoagulation (e.g. warfarin, heparin) 13. Daily use of narcotic analgesia or NSAIDS to control pain associated with venous disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical Success at time of procedure | Immediately post-procedure | Occlusion of treated vein post-procedure |
| Anatomical Success | 2 weeks to 12 months post-procedure | Anatomical success defined as occlusion of treated vessel, as determined by duplex ultrasound. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life score using the Aberdeen Varicose Vein Questionnaire (AVVQ) | 2 weeks, 3 months, 6 months, 12 months post-procedure | 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 |
| Clinical Change using Venous Clinical Severity Score (VCSS) | 2 weeks, 3 months, 6 months, 12 months post-procedure | VCSS evaluates the severity of hallmarks of venous disease - 0 (none), 1 (mild), 2 (moderate), 3 (severe). |
| Pain Score | First 10 days post-operation | Using a numerical rating scale, which ranges from 0 (no pain) to 10 (severe pain) |
| Quality of Life Score using the EQ-5D questionnaire | 2 weeks, 3 months, 6 months, 12 months post-procedure | 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. |
| Occlusion rates | 2 weeks, 3 months, 6 months, 12 months post-procedure | Duplex ultrasound performed at specific timepoints to ensure that treated vein is occluded |
| Patient satisfaction with treatment: survey | 2 weeks, 3 months, 6 months, 12 months post-procedure | A short survey to assess patient satisfaction and if there are any observed improvement in terms of appearance and symptoms post-procedure. |
| Time taken to return to work and normal activities | 10 days post-operation | — |
| Quality of Life Score using the Chronic Venous Insufficiency Questionnaire (CIVIQ) | 2 weeks, 3 months, 6 months, 12 months post-procedure | 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. |
Countries
Singapore
Contacts
Primary ContactCharyl Yap
Outcome results
None listed