NCT02867293已完成不适用
Impact Of Timing Of Drainage Of Massive Ascites On Operative And Post-Operative Course In Living-Donor Liver Transplant Recipients. A Prospective Randomized Controlled Trial.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- graft survival
研究概览
简要总结
Massive ascites is usually controlled over several weeks pre-operatively in liver transplant recipients with the risk of encephalopathy and peritonitis. We hypothesized that intra-operative drainage of ascites will be safe and avoids the inherent risks of pre-operative drainage.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •liver transplant candidates with tense acsites
排除标准
- •severe coagulpathy (INR more than 2 or platlet count less than 50) MELD more than 20
研究组 & 干预措施
Preop-drainage
Active Comparator
ascites drained over the pre-operative week through multiple ultrasound guided paracentesis
干预措施: ultrasound guided ascitic fluid drainage (Procedure)
Preop-drainage
Active Comparator
ascites drained over the pre-operative week through multiple ultrasound guided paracentesis
干预措施: ultrasound (Device)
Op-drainage
Active Comparator
ascetic fluid drained through an abdominal incision after anesthesia
干预措施: operative drainage of ascites through small skin incision after induction of anesthesia (Procedure)
结局指标
主要结局
graft survival
时间窗: one year
次要结局
- patient survival(one year)
研究者
研究点 (2)
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