Three Dietary Regimens in Pre-colonoscopic Bowel Preparation in Children : A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 900
- 试验地点
- 1
- 主要终点
- Boston Bowel Preparation Scale score
研究概览
简要总结
To describe the feasibility and effectiveness of three dietary regimens in precolonoscopy bowel preparation in children
详细描述
The accuracy of endoscopic diagnosis and treatment of safety depends largely on the intestinal cleaning quality. Qualified bowel preparation is a prerequisite for clear vision during colonoscopy. Presently, the common diet for children before colonoscopy in China is a liquid or low residual diet. The liquid and low residual diet often have poor taste and satiety, often resulting in poor compliance of children, especially young children, who are often unwilling to eat a liquid diet, resulting in insufficient caloric supply and unstable blood glucose during bowel preparation. Enteral formula as a kind of high-energy and low-fiber diet has been applied in clinical practice. Currently, there is no comparison between liquid diet, low-residue diet, and enteral formulas in children's bowel preparation in China. Dietary restriction is an indispensable part to ensure the success of the bowel preparation program. There is an urgent need to conduct research on the application of various dietary programs in children's bowel preparation before colonoscopy in China. In order to provide high-quality evidence for the bowel preparation diet program for children.
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
- None
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 2 years～18 years old
- •Children under anesthesia for elective colonoscopy with bowel preparation
排除标准
- •Children who are unable to perform bowel preparation with polyethylene glycol-4000
- •Children whose guardians refuse to participate in this study
- •Children who are unable to eat orally
- •Children with stomy
结局指标
主要结局
Boston Bowel Preparation Scale score
时间窗: After the children finish their bowel preparation, an average of 5 minutes
The nurse will use the Boston Bowel Preparation Scale colonoscopic to evaluate the intestinal fecal trait under colonoscope and record in the case report form. The right side (cecum and ascending colon), transverse colon (hepatic flexion and splenic flexion) and left side (descending colon, sigmoid colon and rectum) were scored respectively. 0 score: a large amount of solid stool remains in the colon; 1 score: liquid and semi-solid feces exist in some intestinal segments; 2 points: a small amount of feces remains, but does not affect the colonoscopic field of view; 3 points: no solid liquid fecal residue in the colon. The total score of the scale is 9 points, 8-9 points is excellent; 6-7 points is good; 4-5 points is average; 0-3 points is Poor.
次要结局
- Number of defecation during bowel preparation(After the children finish their bowel preparation, an average of 1 minute.)
- Adverse reactions of bowel preparation(During children's bowel preparation, an average of 24 hours.)
- Revised-Bristol Stool Form Scale score(After the children finish their bowel preparation, an average of 5 minutes.)
- Medication compliance(After the children finish their bowel preparation, an average of 3 minutes.)
- The times of enema(After the children finish their enema, an average of 1 minute.)