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临床试验/NCT01626040
NCT01626040已完成不适用

Evaluation of One-day Polyethylene Glycol Powder Solution for Colonoscopy in Children

Children's Hospital of Philadelphia1 个研究点 分布在 1 个国家目标入组 178 人开始时间: 2012年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
178
试验地点
1
主要终点
electrolyte disturbances

研究概览

简要总结

The purpose of this study is to examine the effects of current standard of care Polyethylene Gylcol powder (PEG-P)colonoscopy preparation on a patient's serum electrolytes, tolerance of the prep, and how well the bowel is cleansed. The primary aim is to determine the proportion of patients with clinically significant serum electrolyte abnormalities at the time of colonoscopy and how well the prep is tolerated. Secondary objectives include: 1) how well the bowel is cleansed with this preparation, and 2) to determine the most effective way to communicate instructions about the bowel preparation with the child and family.

详细描述

Design is prospective, descriptive observational study involving a single clinical encounter in the Endoscopy suite at CHOP Main at the time of colonoscopy. Patients prescribed the standard of care dosage for PEG-P by their primary gastroenterologist are considered for this study. Study procedures include collection of data from patients that are prescribed the PEG-P dose. In order to evaluate the safety, tolerability, and adherence to PEG-P bowel preparation, data collections include the following: review of medical records, tracking of communication from subjects/parents, blood draw, questionnaire and quality of prep will be assessed. Questionnaire results will be obtained at the initial and only visit. Patients will be given a questionnaire prior to colonoscopy to rate symptoms, ease of preparation and to rate the effectiveness of communication about the preparation. On the day of colonoscopy, prior to the procedure, patients will have an IV placed per standard procedure. At the time of IV placement, a basic metabolic panel and serum magnesium and phosphorus levels will be drawn through the IV for assessment of electrolyte abnormalities. Serum glucose will be captured from medical records as this is collected with standard of care. Patient/parents will grade the preparation tolerance filling out a questionnaire prior to colonoscopy. During colonoscopy, the endoscopist will grade the quality of preparation on a validated residual stool survey (Aronchick scale).

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • Subjects age 1 - 18 years
  • patients receiving standard of care dosing for polyethylene glycol powder
  • patients who had electrolyte results within the last 60 days of enrollment
  • parental / guardian permission (informed consent)

排除标准

  • Patients on the GI inpatient or consult service
  • Weight less than 10 kg
  • Pregnant or lactating females
  • Non-English speaking patient or parent
  • Parents/guardians or subjects who, in the opinion of the Investigator/Study team, may be non-compliant with study schedules or procedures

研究组 & 干预措施

PEG-P prep

Children taking the one day polyethylene glycol powder preparation for outpatient colonoscopy

干预措施: polyethylene glycol powder (Drug)

结局指标

主要结局

electrolyte disturbances

时间窗: at the time of colonoscopy

the proportion of patients with clinically significant serum electrolyte abnormalities at the time of colonoscopy

PEG-P preparation tolerance

时间窗: at the time of colonoscopy

Responses to a questionnaire regarding the tolerance of the PEG-P prep will be recorded

次要结局

  • Colonoscopy preparation efficacy(at the time of colonoscopy)
  • Effective communication(at the time of colonoscopy)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Petar Mamula

Medical Doctor

Children's Hospital of Philadelphia

研究点 (1)

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