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临床试验/NCT02174497
NCT02174497已完成不适用

One-Day Bowel Preparation With Polyethylene Glycol 3350 (Miralax®) is as Effective and Safe as Three-Day Preparation for Colonoscopy in Children

St. John Health System, Michigan1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2008年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
32
试验地点
1
主要终点
Safety of a one day versus a three day colonoscopy preparation in a pediatric population

研究概览

简要总结

This was a blinded study conducted on the efficacy and safety of a one-day versus a three-day bowel preparation in a pediatric population. Limited data is available in this regard, and this study supports the use of a one-day bowel preparation, as this is both safe and effective.

详细描述

Colonoscopy in children and young adults is performed by gastroenterologists for a variety of indications, including but not limited to evaluation of rectal bleeding, chronic diarrhea, family history of polyposis syndromes and surveillance for colon cancer in patients with inflammatory bowel disease. A successful bowel preparation that enables clear visualization of the intestinal mucosa is essential to diagnose and treat the underlying pathology. Currently, gastroenterologists use a variety of colon cleansing preparations, but Polyethylene Glycol (PEG) 3350 given for three to four days appears to be standard. Though it is well tolerated, safe and effective the duration of preparation may cause disruption to the routine and missed school days. To date, there is limited data that shows efficacy of a shorter duration of bowel preparation with PEG. This study aims to compare the efficacy and safety of a one-day preparation with that of a three-day preparation with PEG 3350 as preparation for colonoscopy in children and young adults.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
2 Years 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Pediatric Patients referred for an outpatient colonoscopy

排除标准

  • 未提供

结局指标

主要结局

Safety of a one day versus a three day colonoscopy preparation in a pediatric population

时间窗: 02/08-06/10 (28 months)

The Safety of the different preparations was documented by monitoring serum electrolytes before and after the preparation.

次要结局

  • Tolerability of a one day versus a three day colonoscopy preparation in a pediatric population(02/08-06/10 (28 months))

研究者

发起方
St. John Health System, Michigan
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hernando Lyons, MD

Clinical Assistant Professor of Pediatrics

St. John Health System, Michigan

研究点 (1)

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