Assessment of Comparative Efficacy of Cyanoacrylate Glue vs Endovenous Laser Ablation for Recurrent Varicose Veins due to Residual / Recurrent Incompetent Perforators - RCT
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- -To compare the closure rates of incompetent perforators at 6 month & 1 year post-procedure, as confirmed via Doppler ultrasound.
研究概览
简要总结
INTRODUCTION
Varicose veins (VV) of the lower extremities represent a common and symptomatic condition affecting a significant proportion of the adult population. These veins result in chronic discomfort and functional impairment, significantly reducing patients’ quality of life due to symptoms such as pain, fatigue, and venous ulcers. The Society for Vascular Surgery, American Venous Forum, and AmericanVein and Lymphatic Society clinical practice guidelines emphasize the importance of evidence-based approaches for treating varicose veins, particularly endovenous procedures, including thermal and non-thermal ablation techniques.
Recurrence of varicose veins after treatment often leads to the reappearance of clinical symptoms, necessitating further intervention. Effective management is crucial for addressing incompetent perforator veins, which are a key factor in such recurrences.
The comparative trial aims to evaluate the effectiveness of cyanoacrylate glue (non-thermal) vs endovenous laser ablation (thermal) in patients with recurrent varicosities due to residual / recurrent incompetent perforators vein.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients willing to sign informed consent form and willing to participate in the study.
- •Patients diagnosed with varicose veins.
- •Patients with a clear history of prior treatment of the varicose veins.
- •Patients who have recurrent perforator as identified by ultrasound.
- •Patients belonging to C3 to C6 classes of the CEAP Classification.
排除标准
- •Patients with deep vein thrombosis.
- •Pregnant and lactating women.
- •Patients with immunocompromised status and terminal illness like cancer.
- •Patients with known allergy to cyanoacrylate adhesive.
- •Patients on treatment with anticoagulants or having any coagulopathy.
- •Patients not ready to consent to participate in the study.
结局指标
主要结局
-To compare the closure rates of incompetent perforators at 6 month & 1 year post-procedure, as confirmed via Doppler ultrasound.
时间窗: 6 month and 1 year.
- To assess improvement in clinical symptoms using the Venous Clinical Severity Score (VCSS) at 6 month and 1 year.
时间窗: 6 month and 1 year.
次要结局
- - To analyze the incidence of complications (immediate, at 6 month, and at 1 year) following each treatment modality.(- To compare the average procedure time between n-butyl cyanoacrylate glue and endovenous laser ablation.)
研究者
Dr Lalit Kumar Nirwan
Datta Meghe Institute of Higher Education and Research (Deemed to be University)