Comparison of Pain After Uterine Artery Embolization Using Gelatin Microsphere or Tris-acryl Gelatin Microsphere in Patients With Symptomatic Fibroids: A Prospective, Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Pain intensity by numerical rating scale
研究概览
简要总结
This study is a prospective and randomized investigation planned to compare pain after uterine artery embolization using Gelatin microsphere or tris-acryl gelatin microsphere in 60 patients with symptomatic fibroids.
详细描述
This investigational study is designed to compare pain after uterine artery embolization using Gelatin microsphere or tris-acryl gelatin microsphere in patients with symptomatic fibroids.
The primary end-points will be evaluated by assessing the maximum Visual Analogue Scale (VAS) score obtained for each time points within 24 hours after embolization.
Secondary end-points consist of evaluating six items: 1) fentanyl and analgesic usage within 24 hours, 2) comparison of symptom severity score and health-related quality of life score, 3) comparison of postoperative inflammation, 4) assessment of tumor necrosis degree in Magnetic Resonance Imaging, 5) fluoroscopy and procedure time comparison, and 6) assessment of residual ovarian function before and after surgery (Serum AMH).
This study included patients between the ages of 20 and less than 60 years of age who were diagnosed with uterine myoma and planned to undergo uterine artery embolization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 59 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •A patient aged between 20 and under 60 who decided to undergo uterine artery embolization for symptomatic uterine myoma.
排除标准
- •Bradycardia on electrocardiogram (< 45 bpm)
- •Ventricular conduction abnormalities
- •Liver failure
- •Kidney failure
- •Uncontrolled high blood pressure
- •Obesity (BMI ≥ 30 ㎏/㎡)
- •Patients who are allergic to drugs
- •Patients who cannot read consent forms such as illiterate or foreigners
- •Pregnant woman
结局指标
主要结局
Pain intensity by numerical rating scale
时间窗: 0-24 hours after embolization
0-10 numerical rating scale (0, no pain at all; 10, worst pain imaginable
次要结局
- Symptom severity score(3 months)
- Tumor necrosis degree(3 months)
- Fluoroscopy and procedure time(procedure time)
- Postoperative inflammation(24 hours)
- Serum Anti-Mullerian Hormone (AMH)(3 months)
- Fentanyl and analgesic usage volume(24 hours)