Treatment of Venous Malformation by Direct Puncture Repair: Ethanol Versus Polidocanol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Disfigurement questionnaire
研究概览
简要总结
Vascular malformations are birth defects that happen when different stages of angiogenesis shut down. 44 - 64% of all vascular malformations are venous malformations (VMs). Sclerotherapy is the first treatment line for VMs. It acts by getting rid of the vascular endothelial cells in the lesion. One of the most common and well researched sclerosing agents for VMs is polidocanol, which is a popular counterpart for concentrated ethanol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Months 至 36 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with venous malformation of both genders and age above one year.
排除标准
- •Age below one year.
- •Patients had any other vascular malformations.
- •Indication for contrast material or Alcohol and polidocanol injection.
- •Unfit for general anesthesia. 5) Pregnancy. 6) Skin infection, inflammation, and ulcers.
- •Pulmonary embolism.
- •Acute Ischemia, and acute DVT.
结局指标
主要结局
Disfigurement questionnaire
时间窗: 6 months post operative
Disfigurementof the affected part may be unchanged, or decreased or disppeared, or relapsed
Heaviness questionnaire
时间窗: 6 months post operative
Heaviness of the affected part may be unchanged, or decreased or disppeared, or relapsed
size of venous malformation
时间窗: 6 months post operative
it assess the size of malformations after injection; which may be unchanged, or decreased or disppeared, or relapsed
Degree of satisfaction
时间窗: 6 months post operative
It may be; Very satisfied, or satisfied, or not satisfied, or Dissatisfied.
次要结局
未报告次要终点
研究者
Walied Khereba
Principal Investigator
Al-Azhar University