Individualized Volume of Oral Contrast Agent Based on the Clinical Risk Factor in CT Enterography: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Adequate small bowel distention
研究概览
简要总结
Small bowel distension is mandatory for the assessment of the bowel wall in CT enterography, but some patients were sufferring inadequate small bowel distension. So, it is important to prescribe personalized regimen according to patient's personal characteristics.
详细描述
CT enterography has become an important tool in the evaluation of small bowel diseases, especially in patients with inflammatory bowel diseases. Small bowel distension is mandatory for the assessment of the bowel wall. So, it is important to find clinical risk factors for inadequate small bowel distension and prescribe personalized regimen according to patient's personal characteristics to reduce patient acceptance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Care Provider, Outcomes Assessor)
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
- •patients undergoing CT enterography
排除标准
- •patients with a history of GI surgery
- •patients with known or suspected bowel obstruction or perforation
- •patients with severe chronic renal failure (creatinine clearance<30 ml/min)
- •patients with uncontrolled hypertension (systolic blood pressure>170 mm Hg, diastolic blood pressure>100 mm Hg)
- •patients with acute upper GI bleeding
- •patients with severe inflammatory bowel disease or megacolon
- •patients with documented allergy to intravascular contrast agent
- •patients with pregnancy or lactation
- •patients hemodynamically unstable
- •patients unable to give informed consent.
研究组 & 干预措施
Individualized group
Participants are given different volume of a preparation of mannitol based on BMI as oral contrast agent over an hour prior to the examination.
干预措施: 1500ml of 2.5% mannitol (Drug)
Individualized group
Participants are given different volume of a preparation of mannitol based on BMI as oral contrast agent over an hour prior to the examination.
干预措施: different volume of 2.5% mannitol (Drug)
conventional group
Participants are given 1500ml of a preparation of mannitol as oral contrast agent over an hour prior to the examination.
干预措施: 1500ml of 2.5% mannitol (Drug)
结局指标
主要结局
Adequate small bowel distention
时间窗: 4 month
The assessment system includes four parts 1. Whether the contrast reached the caecum is evaluate and recorded as "yes" or "no" 2. The overall presence of inhomogeneous contrast is evaluated and recorded as "yes" or "no" 3. The maximum dimension of a single loop in each quadrant was recorded. 4. The scale of loops of small bowel distended are evaluated and recorded as "0%-25%","26%-50%","51%-75%","75%-100%"
Clinical risk factors for inadequate small bowel distention
时间窗: 2 month
Number of clinical risk factors for inadequate small bowel distention
次要结局
- Side effects(4 month)
研究者
Yanqing Li
vice president of Qilu Hospital
Shandong University