Early Versus Elective Colonoscopy in the Management of Lower Gastrointestinal Bleeding
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Further bleeding
研究概览
简要总结
Study hypothesis is that performing early colonoscopy in patients who present to the hospital with lower GI bleeding improves their outcome.
Patients who are admitted with bleeding from their rectum and a negative endoscopic exam of the stomach and upper intestine are randomized (like flipping a coin) to receive a colonsoscopy either as an emergency (within 12 hours) or as a routine procedure (36 hours after admission). Patients are followed during their hospitalization to see if they have further bleeding, if they require blood transfusions, if they need other diagnostic tests, if they need surgery or other treatments, and how long they stay in the hospital.
详细描述
The aim of this study is to determine if performing early colonoscopy in patients who present to the hospital with lower GI bleeding improves their outcome.
Patients who are admitted with bleeding from their rectum and clinical evidence of a significant bleeding episode (elevated heart rate, low blood pressure, or need for blood transfusion) have immediate upper endoscopy (examination of the stomach with a flexible rubber tube with a light and video camera on the end). If this shows no source of bleeding, the patients are randomized (like flipping a coin) to receive a colonsoscopy (examination of the large intestine with a flexible rubber tube with a light and video camera on the end) either as a emergency (within 12 hours) or as a routine procedure (36 hours after admission).
Patients are followed during their hospitalization to see if they have further bleeding, if they require blood transfusions, if they need other diagnostic tests, if they need surgery or other treatments, and how long they stay in the hospital.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are admitted with rectal bleeding and one of the following high-risk features:
- •HR > 100/min
- •Systolic blood pressure <100 mmHg
- •Orthostasis -considered as increase in HR by> 20/min on assuming erect position as well as by decrease by 20 mmHg in systolic blood pressure
- •Need for blood transfusion
- •Drop in hemoglobin > 1.5 g/dl or in hematocrit of > 6% in 6 hours
排除标准
- •Inability to give informed consent
- •Peritoneal signs
- •Severe co-morbidities that would preclude the use of colonoscopy in standard clinical practice
研究组 & 干预措施
Early colonoscopy
Colonoscopy performed within 12 hours of presentation
干预措施: Early colonoscopy (Procedure)
Elective colonoscopy
Colonoscopy 36-60 hours after presentation
干预措施: Elective colonoscopy (Procedure)
结局指标
主要结局
Further bleeding
时间窗: Duration of hospitalization (randomization to date of discharge from hospital)
次要结局
- Diagnostic yield(Duration of hospitalization (randomization to date of discharge from hospital))