Prospective Study to Evaluate QoL Scores and Post-operative Complications Using TEThA (Transfixing Endovenous Thermal Ablation) Technique in Tributary Veins Treatment
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 主要终点
- Quality of Life score using Aberdeen Varicose Veins Questionnaire (AVVQ)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with varicose veins > 2mm associated with reflux of great or small saphenous veins with CEAP C2 to C6
排除标准
- •Patients under 18 years Acute or previous thrombophlebitis or deep vein thrombosis. Pregnant patient. Reject the Informed Consent Form.
结局指标
主要结局
Quality of Life score using Aberdeen Varicose Veins Questionnaire (AVVQ)
时间窗: 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)
时间窗: 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.
次要结局
- 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)
研究者
Nara Medeiros Cunha de Melo Vasconcelos
MD
Science Valley Research Institute