Precision Preoperative Embolization of Pelvic Tumors to Improve Surgical Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- Perioperative blood loss
研究概览
简要总结
The main purpose of this study is to assess the efficacy of precision preoperative embolization in decreasing operative blood loss, reducing surgical complications in pelvic tumor surgery. Furthermore the study aims at describing the vascularity in a series of pelvic tumors, and to correlate this with perioperative blood loss.
详细描述
The main purpose of this study is to assess the efficacy of precision preoperative embolization in decreasing operative blood loss, reducing surgical complications in pelvic tumor surgery，which including poor wound healing，nerve injury，and pelvic organs dysfunction. Furthermore the study aims at describing the vascularity in a series of pelvic tumors,which contains four grade：poor，moderate，rich and abundant and to correlate this with perioperative blood loss.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary or metastatic pelvic tumor
- •Confirmed by contrast-enhanced magnetic resonance imaging (MRI) or computed tomography (CT) of the pelvic
- •Planned surgical resection
排除标准
- •Contrast medium allergy
- •Uncontrolled or concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
结局指标
主要结局
Perioperative blood loss
时间窗: Measured intraoperatively
Perioperative blood loss measured intraoperatively
次要结局
- Vascularization grade of pelvic tumors(At the angiographic procedure prior to embolization performed 0-24 hours before surgery)
- postoperative blood loss(Within 2 postoperative days)
- Adverse events related to angiography or embolization(Within 2 postoperative days)
- Adverse events related to surgery(Within 30 postoperative days)
研究者
Zhi Xin
Doctor
Peking University People's Hospital