Comparison of Pain After Uterine Artery Embolization Using Non-spherical Polyvinyl Alcohol Particles or Tris-acryl Gelatin Microsphere in Patients With Symptomatic Fibroids
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Pain intensity by numerical rating scale
研究概览
简要总结
The primary purpose of this study is to compare pain after uterine artery embolization using non-spherical polyvinyl alcohol particles or tris-acryl gelatin microsphere in patients with symptomatic fibroids
详细描述
Uterine artery embolization(UAE) is a minimally invasive treatment alternative to hysterectomy and myomectomy in symptomatic fibroids. However, post-procedural pain after UAE remains a major problem. The non-spherical polyvinyl alcohol particle and tri-acryl gelatin microsphere are two embolic materials used for UAE.Therefore, the aim of study is to compare pain intensity and inflammation after uterine artery embolization using non-spherical polyvinyl alcohol particles or tris-acryl gelatin microsphere in patients with symptomatic fibroids
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Uterine artery embolization due to multiple fibroids
排除标准
- •Severe liver or kidney dysfunction
- •Drug allergy
- •Bradycardia (<45 bpm) or heart block
- •Uncontrolled hypertension
研究组 & 干预措施
Tris-acryl gelatin microsphere
For embolic material, Tris-acryl gelatin microsphere is used.
干预措施: Non-spherical polyvinyl alcohol particle or Tris-acryl gelatin microsphere (Device)
Non-spherical polyvinyl alcohol particle
For embolic material, non-spherical polyvinyl alcohol particle is used.
干预措施: Non-spherical polyvinyl alcohol particle or Tris-acryl gelatin microsphere (Device)
结局指标
主要结局
Pain intensity by numerical rating scale
时间窗: 0-24 h after UAE
0-10 numerical rating scale (0, no pain at all; 10, worst pain imaginable
次要结局
- C-reactive protein(24 h after UAE)
- Neutrophil percentage(24 h after UAE)
- Neutrophil-to-lymphocyte ratio(24 h after UAE)
- Mean platelet volume(24 h after UAE)
- Sucessful rate at 3 month after UAE measured by MRI(3 month after UAE)
- Platelet-to-lymphocyte ratio(24 h after UAE)
- White blood cell count(24 h after UAE)
研究者
So Yeon Kim
Assistant professor
Severance Hospital