Efficacy, Safety and Tolerability of Different Bowel Preparation Before Colonoscopy in Children Over 2 Years Old
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 315
- 试验地点
- 1
- 主要终点
- Bowel cleansing
研究概览
简要总结
Electronic colonoscopy plays an important role in the diagnosis and follow-up of intestinal diseases in children.
详细描述
The adequacy of bowel preparation before colonoscopy is particularly important for the visualization of intestinal mucosa under colonoscopy. Some studies have shown that bowel preparation must be customized according to the age, weight and clinical status of the child. However, there is no internationally recognized standard scheme for pediatric intestinal reserve. In pediatric clinical trials, polyethylene glycol with electrolyte solution (PEG-ELS) is more effective than bisacodyl, folium sennae and magnesium citrate. PEG-ELS is an electrolyte balanced isotonic solution, which can be used to clean the intestinal tract by large volume irrigation. Polyethylene glycol 4000 is a long-chain linear polymer, which can hardly absorb and decompose after oral administration. It can effectively increase the composition of intestinal fluid, stimulate intestinal peristalsis, cause watery diarrhea, and achieve the purpose of cleaning the intestine. The inorganic salt composition and proper amount of water in the formula ensure the balance of water and electrolyte exchange between intestinal tract and body fluid. In this study, PEG-ELS short protocol and long protocol were selected for intestinal preparation, and the effectiveness and safety of different intestinal preparation protocols under electronic colonoscopy for children over 2 years old were compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 22 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed children in Department of Gastroenterology at Children's Hospital of Fudan University
- •According to the indications of electronic colonoscopy, colonoscopy was performed for the first time
- •Age: 2-22 years old
排除标准
- •Having contraindications of electronic colonoscopy
- •Having contraindications of general anesthesia
- •Previous abdominal surgery
- •Chronic constipation
- •There is evidence of intestinal stenosis and gastrointestinal malformation
- •Laxatives or drugs in the intestinal preparation protocol of this study have been used before bowel preparation
- •Disagree the use of the bowel preparation protocol developed in the study
结局指标
主要结局
Bowel cleansing
时间窗: During the operation of electronic colonoscopy (about 15 min )
Bowel cleansing was assessed by Boston bowel preparation scale (BBPS). The scores of left, middle and right colon were added up to the total score of BBPS, with the lowest score of 0 and the highest score of 9. The score of 8-9 represents excellent bowel preparation, 6-7 represents good, 4-5 represents average, and 0-3 represents poor. Excellent and good for intestinal preparation are qualified, general and poor for intestinal preparation are unqualified.
次要结局
- Adverse events(up to 30 minutes after colonoscopy)
- Adverse reactions receiving polyethylene glycol with electrolyte solution(During bowel preparation (about 24 hours))
- Enema rate before colonoscopy(immediately before colonoscopy)
- Compliance with polyethylene glycol with electrolyte solution (PEG-ELS)(During bowel preparation (about 24 hours))
- Rate of nasal feeding PEG-ELS(During bowel preparation (about 24 hours))
- Times of washing under colonoscopy(During the operation of electronic colonoscopy (about 15 mins))