Bedside Percutaneous Drainage of Liver Abscess in the Emergency Department by Trained Emergency Physicians versus Radiologist A Non Inferiority Randomized Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- ED length of stay (in hours)
研究概览
简要总结
Rationale: Early diagnosis of liver abscess and immediate intervention with ultrasound-guided percutaneous drainage not only lead to better patient prognosis but can also lead to a significant decrease in the ED waiting time. Trained emergency physicians (EP) can perform the procedure immediately in the ED
Novelty: To the best of our knowledge, this will be the first study comparing the feasibility, efficacy, and safety of EP as the immediate performer of liver abscess drainage.
Objectives: The primary objective of this study is to investigate the role of emergency physicians as a performer of liver abscess drainage compared to a radiologist in terms of ED length of stay. The secondary objectives will be to assess differences in complications, clinical outcomes, and patient satisfaction.
Methods: This randomized controlled trial (RCT) will be conducted in the ED of AIIMS New Delhi. The arms will be according to the performer, i.e., an emergency physician (EP-driven) versus a radiologist (Radiology-driven). A total of fifty-seven patients will be included in each arm. All adult patients with a diagnosis of liver abscess in the ED will be included, irrespective of clinical severity. Patients with organized liver abscess contents, abscess size < 5cm coagulopathy, thrombocytopenia, or any other contraindications.
Expected outcomes: We hypothesize that the ‘EP-driven’ procedure will result in a significantly shorter length of ED stay and better patient satisfaction. The complication rates and duration of the in-situ catheter requirement are expected to be similar in both arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients presenting with a diagnosis of liver abscess in the emergency department with an indication of urgent percutaneous drainage.
排除标准
- •Organised liver abscess or no urgent indication of emergency percutaneous drainage or thrombocytopenia or coagulopathy.
结局指标
主要结局
ED length of stay (in hours)
时间窗: TILL DISCHARGED FROM EMERGENCY DEPARTMENT
次要结局
- Incidence of peri-procedure complications: abscess rupture, development of intraabdominal compartment syndrome or peritonitis, evidence of intraabdominal bleeding, continuous bleeding from the puncture site, hemodynamic instability, intractable coughs or hiccups, shortness of breath, upper gastrointestinal bleeding, lower gastrointestinal bleeding, pericardial effusion, and death(Within 6 hours of the procedure)
- Incidence of complications within the next week(Within the next 7 days of the procedure)
- Time duration from the time of diagnosis of the liver abscess to percutaneous drainage time(Time of Diagnosis to Procedure)
- Total duration of catheter requirement for adequate treatment of liver abscess(From insertion of catheter to removal of catheter)
- Patients satisfaction(during the emergency department stay)
研究者
NAYER JAMSHED
ALL INDIA INSTITUTE OF MEDICAL SCIENCES NEW DELHI