Evaluating QoL and Postoperative Complications Using TEThA Technique in the Treatment of Tributary Veins
- Conditions
- Varicose VeinsLaserQuality of Life
- Registration Number
- NCT06669260
- Lead Sponsor
- Nara Medeiros Cunha de Melo Vasconcelos
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 20
Patients with varicose veins > 2mm associated with reflux of great or small saphenous veins with CEAP C2 to C6
Patients under 18 years Acute or previous thrombophlebitis or deep vein thrombosis. Pregnant patient. Reject the Informed Consent Form.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Quality of Life score using Aberdeen Varicose Veins Questionnaire (AVVQ) 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) 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 Outcome Measures
Name Time Method Lymphedema 30 days and 180 days Presence or absence of lymphedema diagnosed by exam of lymphoscintigraphy in the limb treated by endovenous laser TEThA technique
Sclerothrombus 7 days Presence of Sclerothrombus (US doppler)
Complementary treatment 180 days Percentage of participants with residual veins
Presence of induration 30 days and 180 days Induration noticed on the saphenous vein path (phototodocumentation, US Doppler)
Presence of Paresthesia 30 days and 180 days Presence or absence of paresthesia in the limb treated by endovenous laser TEThA technique
Skin burns 7 days Presence or absence of skin burns in the limb treated by a endovenous laser with TEThA technique
Hyperpigmentation Baseline, 30 days and 180 days Presence or absence of hyperpigmentation in the limb treated by a endovenous laser with TEThA tecnique (phototodocumentation, US Doppler)