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临床试验/NCT02102373
NCT02102373已完成不适用

Clear Liquid vs Low-fiber Diet in Bowel Cleansing for Colonoscopy in Children: a Randomized Trial

Medical University of Warsaw2 个研究点 分布在 1 个国家目标入组 184 人开始时间: 2014年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
184
试验地点
2
主要终点
Bowel preparation of the whole colon

研究概览

简要总结

Colonoscopy is a routinely performed procedure in children and adolescents. Proper visualization of the intestinal mucosa is highly dependent on the quality of the bowel preparation. European Society of Gastrointestinal Endoscopy (ESGE) emphasizes that the timing of bowel preparation is the key factor and recommends that the delay between the last dose of bowel preparation and colonoscopy should be minimized. Timing of bowel preparation prior to colonoscopy has not been studied in children population, yet. The diet regimen before colonoscopy is likely less important than the timing of bowel preparation, however may influence the well-being of children.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
6 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age 6-18 years
  • Elective colonoscopy

排除标准

  • Chronic renal, liver, or heart failure
  • Acute surgical abdominal conditions (e.g., acute obstruction or perforation)
  • Acute surgical abdominal conditions (e.g., acute obstruction or perforation)
  • Any prior gastrointestinal surgery

结局指标

主要结局

Bowel preparation of the whole colon

时间窗: in 15 minutes after colonoscopy

Boston bowel preparation score for the whole colon assessed by the endoscopist in 15 minutes after the procedure

次要结局

  • Time between the last dose of PEG and colonoscopy(in 15 minutes after colonoscopy)
  • Bowel preparation for colon sections(in 15 minutes after colonoscopy)
  • Duration of PEG taking(in 15 minutes after colonoscopy)
  • Tolerability(in the first 6 hours after colonoscopy)
  • Acceptability(in the first 6 hours after colonoscopy)

研究者

发起方
Medical University of Warsaw
申办方类型
Other
责任方
Principal Investigator
主要研究者

Aleksandra Banaszkiewicz

MD PhD

Medical University of Warsaw

研究点 (2)

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