ULTRASOUND GUIDED ASPIRATION PLUS ANTIBIOTICSVS ANTIBIOTICS IN CHILDREN WITH LIVER ABSCESS: A RANDOMIZED CONTROLLED TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Clinical cure is defined as:Absence of documented fever, abdominal pain and Ultrasound showing reduction in size of liver abscess.
研究概览
简要总结
This study is an attempt to compare clinical outcome of two most widely used regimens for management of liver abscess, i.e. percutaneous needle aspiration plus antibiotics and medical management alone. Enrolled patients will be randomized into two groups and treatment will be started. One group will receive antibiotics and aspiration of liver abscess will be carried out within 24-48 hours of admission and after correction of any coagulation abnormalities and initial stabilization of the patient.Another group will receive only antibiotics. Clinical, laboratory and ultrasound parameters will be monitored as per protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 1.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Ultrasound within the preceding seven days suggestive of uncomplicated liver abscess 3-8 cm (for children 1-5 years) or 3-10 cm (for children 5-18 years).
排除标准
- •1.Left lobe liver abscess 2.Caudate lobe liver abscess 3.Ultrasound features suggestive of imminent rupture i.e., less than 1 cm liver tissue around abscess cavity 4.Associated with other surgical conditions acute appendicitis, acute cholecystitisetc 5.Known immune-compromised state 6.Children with signs and symptoms suggestive of liver cell failure.
结局指标
主要结局
Clinical cure is defined as:Absence of documented fever, abdominal pain and Ultrasound showing reduction in size of liver abscess.
时间窗: 6 weeks
次要结局
- To compare rate of clinical response:(1.Fever resolution time)