Effect of Domperidone on Completion Rate of Vedio Capsule Endoscopy: a Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Completion rate of capsule endoscopy
研究概览
简要总结
Video capsule endoscopy (VCE) has become an established technique to investigate the presence of small bowel pathology. But the limited battery life of capsules can lead to incomplete small bowel visualization. There is a rationale to use prokinetic agents prior to VCE reduce the chances of an incomplete small bowel examination via decrease gastric transit time (GTT). Investigators are aimed to prospectively compare the completion rate of VCE in pediatric patients receiving prokinetic with those receiving no prokinetic.
详细描述
Eligible children were randomly divided into two groups: domperidone prior to VCE and water prior to VCE. The primary outcome measure was the completion rate. Secondary outcome measures included the GTT and SBTT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Indications of capsule endoscopy;
- •Informed consent form obtained.
排除标准
- •Contraindication of capsule endoscopy;
- •Domperidone allergy;
- •Unwilling to participate.
研究组 & 干预措施
Experimental: Domperidone
5ml domperidone prior to VCE
干预措施: Domperidone (Drug)
Control: water
5ml warm water prior to VCE
干预措施: water (Dietary Supplement)
结局指标
主要结局
Completion rate of capsule endoscopy
时间窗: assessed through study completion, an average of 1 year
CE was considered complete when the cecum was reached within recording time.
次要结局
- Gastric transit time (GTT)(assessed through study completion, an average of 1 year)
- small bowel transit time (SBTT)(assessed through study completion, an average of 1 year)
研究者
Ying HUANG
The director of gastroenterology of Children's Hospital of Fudan University
Children's Hospital of Fudan University