Prospective Study to Evaluate QoL Scores and Post-operative Complications Using TEThA (Transfixing Endovenous Thermal Ablation) Technique in Tributary Veins Treatment
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Varicose Veins
- Sponsor
- Nara Medeiros Cunha de Melo Vasconcelos
- Enrollment
- 20
- Primary Endpoint
- Quality of Life score using Aberdeen Varicose Veins Questionnaire (AVVQ)
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
Endovenous laser thermoablation is a well-established alternative for the treatment of tributary veins. We believe that it is possible to improve the techniques described in the literature, aiming not only to allocate the laser fiber within the venous lumen, but mainly to transfix the vessel walls - a technique called TEThA (Transfixing Endovenous Thermal Ablation).
Detailed Description
Endovenous laser thermoablation is an alternative for the treatment of tributary veins that is not yet one of the main alternatives in our specialty's consensus. In order to treat tributary veins applying laser, several punctures and the complete placement of introducer catheters are recommended in order to position the endolaser fiber in the lumen of the varicose vein before performing thermoablation of the saphenous veins. However, we believe that it is possible to perform an adequate treatment with a smaller number of punctures, aiming not only to place the laser fiber inside the venous lumen, but mainly to transfix the vessel walls - a technique called TEThA (Transfixing Endovenous Thermal Ablation). Our aim is to carry out a prospective cohort study to assess the Aberdeen score in patients undergoing the TEThA technique for the treatment of tributary veins.
Investigators
Nara Medeiros Cunha de Melo Vasconcelos
MD
Science Valley Research Institute
Eligibility Criteria
Inclusion Criteria
- •Patients with varicose veins \> 2mm associated with reflux of great or small saphenous veins with CEAP C2 to C6
Exclusion Criteria
- •Patients under 18 years Acute or previous thrombophlebitis or deep vein thrombosis. Pregnant patient. Reject the Informed Consent Form.
Outcomes
Primary Outcomes
Quality of Life score using Aberdeen Varicose Veins Questionnaire (AVVQ)
Time Frame: Baseline, Timepoints post-procedire: 1 month, 3 months, 6 months
AVVQ is an easy-to-administer, self-administered instrument, it consists of 3 dimensions, which are physical, sociofunctional and psychological. It is interpreted through a score, which can vary between 0 and 100, with 0 representing no evidence of varicose veins and 100 the most serious problem associated with varicose veins.
Quality of life score using the Chronic Venous Insufficiency Questionnaire (CIVIQ)
Time Frame: Timepoints post-procedire: 1 month, 3 months, 6 months
CIVIQ-14 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 from 0 to 100 - the higher the value, the poorer the quality of life.
Secondary Outcomes
- Hyperpigmentation(Baseline, 30 days and 180 days)
- Presence of Paresthesia(30 days and 180 days)
- Skin burns(7 days)
- Lymphedema(30 days and 180 days)
- Sclerothrombus(7 days)
- Complementary treatment(180 days)
- Presence of induration(30 days and 180 days)