NCT01869296已完成2 期
The Effect of Endoscopy Water Pump Flow Rates on Successful Unsedated Colonoscopy by Water Immersion Method: a Randomized Controlled Trial
Gadjah Mada University1 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2013年5月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- cecal intubation rate
研究概览
简要总结
The purpose of this study is to compare the cecal intubation rate between two endoscopy water pump with different flow rates (1.7 ml/sec vs 10.4 ml/sec) in water immersion colonoscopy examination in unsedated patients undergoing diagnostic colonoscopy.
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
- Single (Participant)
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
- •Adult > 18 years old with indication for colonoscopy, such as chronic diarrhea, chronic constipation, hematochezia, chronic lower abdominal pain, positive fecal occult blood test, and other change of bowel habit symptoms indicative of need for diagnostic colonoscopy examination
排除标准
- •Patients refuse to participate, patient with obstructive lesion in the colon distal of the cecum, patients with experienced of colon resection, hemodynamically unstable, severe cardiac disorders (such as acute myocardial infarction, unstable angina, malignant arrhythmia, and moderate to severe congestive heart failure), patients with fecal obstruction (whatever the causes) so that impossible to pass the scope through the obstructed segment.
研究组 & 干预措施
higher flow rates endoscope pump
Active Comparator
higher flow rates endoscope water pump : 10.4 ml/sec
干预措施: higher flow rates (Procedure)
lower flow rates endoscope water pump
Experimental
lower flow rates endoscope water pump : 1.7 ml/sec
干预措施: lower flow rates (Procedure)
结局指标
主要结局
cecal intubation rate
时间窗: 1.5 years
次要结局
- Cecal intubation time(1.5 years)
- Abdominal compression(1.5 years)
- Position change(1.5 years)
- Abdominal discomfort score(1.5 years)
- Diagnostic lesions(1.5 years)
- Causes of unsuccessful(1.5 years)
- Willingness to repeat(1.5 years)
研究者
PUTUT BAYUPURNAMA
MD, Internist-Gastroenterologist
Gadjah Mada University
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Effect of Water Exchange Method on Single-balloon EnteroscopySingle Balloon EnteroscopyNCT01942863Air Force Military Medical University, China110
Unknown
不适用
The Effect of Two Different Endoscopic Entry Techniques on Postoperative Gastrointestinal FunctionGastrointestinal Disorder PostoperativeNCT02543853Zeynep Kamil Maternity and Pediatric Research and Training Hospital140
招募中
不适用
Evaluation of the speed and accuracy of WiFi video laparoscopeintra tracheal intubation.Failed or difficult intubationT88.4IRCT20130304012695N10Tehran University of Medical Sciences90
尚未招募
不适用
To compare the intubation characteristics of unaided endotracheal tube, aided with a stylet or with bougie using the McGrath videolaryngoscopeCTRI/2021/07/035094Vardhman Mahavir Medical College and Safdarjung Hospital
已完成
不适用
Endotracheal Tube Cuff Pressure MeasurementTrauma, BrainVentilator Associated PneumoniaEndotracheal AspirationMoralityNCT04397952Bagcilar Training and Research Hospital30