NCT03685994Unknown不适用
The Incidence of Sleep Disorders After Transjugular Intrahepatic Portosystemic Shunt
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The incidence of sleep disorders after TIPS
研究概览
简要总结
The Purpose of a study to investigate the incidence of postoperative sleep disorders in patients undergoing transjugular intrahepatic portosystemic shunt ,and to analyze the relationship between risk factors and prognosis of sleep disorders.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of cirrhosis (clinical or by liver biopsy)
- •Portal hypertension patients with defined indications for TIPS treatment
- •Aged 18-75 years old
- •Signed written informed consent
排除标准
- •mental or nervous system diseases
- •Patients with alcoholic cirrhosis who are still drinking
- •Accompanied by serious heart, lung, brain and kidney diseases
- •Preoperative diagnosis of sleep disorder
- •Patients who are illiteracy
- •The total score of the preoperative Hamilton anxiety scale was greater than or equal to 14 points, and the total score of 17 points of the Hamilton depression scale was greater than or equal to 18 points
结局指标
主要结局
The incidence of sleep disorders after TIPS
时间窗: 1 year
The number of patients who suffer from sleep disorders after TIPS
次要结局
- mortality(1 year)
- Incidence of hepatic encephalopathy(1 year)
研究者
luo xuefeng
Clinical Professor
West China Hospital
研究点 (1)
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