Efficacy of cyanoacrylate glue for recurrent perforators after primary closure of lower limb varicose veins: A prospective study
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Efficacy of closure rates of recurrent perforators
研究概览
简要总结
The study titled Cyanoacrylate Glue for Recurrent Perforators After Primary Closure of Lower Limb Varicose Veins: A Prospective Study aimed to evaluate the effectiveness and safety of using cyanoacrylate glue for the treatment of recurrent perforators causing following primary closure of varicose veins.
Background
Chronic venous insufficiency of the lower limb is a common condition that affects a significant portion of the population. The most prevalent form of this disease is due to great saphenous vein GSV and perforator valvular incompetence, leading to symptoms ranging from fatigue and swelling to more severe complications like ulceration. Recurrent perforators post primary closure causes recurrent varicose vein and symptoms.
Purpose
The trial will be conducted to explore the technical feasibility, efficiency, and safety of cyanoacrylate embolization using n butyl cyanoacrylate glue. The study sought to determine if this method could be an effective outpatient procedure for treating recurrent perforators following primary closure of varicose veins.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient of lower limb varicose veins previously treated with any modality.
- •Patient who have recurrent perforator identified on Ultrasound.
- •Patient willing to sign informed consent and participate in study.
排除标准
- •Patients with Deep venous thrombosis.
- •Pregnant and lactating women.
- •Undiagnosed cause of recurrence of varicose veins.
- •Any patient with terminal illness such as cancer.
- •Any other condition that in the view of Principal Investigator demands exclusion from the study.
结局指标
主要结局
Efficacy of closure rates of recurrent perforators
时间窗: 6 wks
Improvements in symptoms
时间窗: 6 wks
Complications
时间窗: 6 wks
次要结局
- Secondary outcome(Improvement in Symptoms To evaluate the improvement in symptoms associated with varicose veins due to recurrent perforator following closure using cyanoacrylate glue at 6 wks)
研究者
Dr Lalit Nirwan
Datta Meghe Hospital Sawangi