Evaluation of Short Course, Single-dose Polyethylene Glycol (PEG) 3350 Regimen for Colonoscopy Bowel Preparation in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Efficacy of Cleanout
研究概览
简要总结
The investigators propose to conduct a prospective study of a widely used bowel preparation regimen (polyethylene glycol 3350 + a sports drink) on pediatric patients who undergo a colonoscopy performed by the pediatric gastroenterology service at WRAMC/WRNMMC between 1 Sep 2010 and 31 Dec 2011. This study will involve the following: determine efficacy of the cleanout, assess tolerability and acceptance of the regimen, determine an appropriate duration to complete the regimen and assess for any electrolyte changes or side effects.
详细描述
Purpose: It is hoped that by determining acceptability, safety and efficacy of this widely used short course, single-dose bowel preparation regimen, pediatric gastroenterologist can have a standardized bowel preparation for colonoscopy that will be acceptable to pediatric patients and their parents.
Research Design: This study is a prospective medication trial. It will utilize laboratory data to detect any electrolyte changes, a patient questionnaire to assess an acceptable duration, tolerance and side effects of the regimen. Efficacy of the cleanout will be assessed using a published standardized bowel preparation scale by the endoscopist at the completion of the colonoscopy.
Methodology /Technical Approach (including the number of subjects to be studied.): We estimate that 50 patients aged 8-18 years old military dependents who are undergoing a colonoscopy by the Pediatric Gastroenterology service at WRAMC/WRNMMC will be enrolled in the study between 1 Sep 2010 and 31 Dec 2011.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female DEERS-eligible dependent military health care beneficiaries age 8 to 18 years old evaluated by Pediatric Gastroenterology service at WRAMC and are scheduled to undergo a colonoscopy between 1 Sep 2010 - 31 Dec 2011 and do not meet exclusion criteria.
排除标准
- •Age less than 8 years or greater than 18 at time of procedure
- •Colonic surgery including hemicolectomy, colectomy, ileostomy, or multiple abdominal surgeries.
- •Oral aversion or other feeding disorder.
- •Inability to drink large amount of liquids.
- •Aspiration risk.
- •Renal disease or pre-cleanout electrolytes outside normal range.
- •Significant cardiovascular disease.
- •Allergy to food coloring or polyethylene glycol
- •Inpatient or emergency colonoscopy.
- •Current nasogastric tube in place.
- •Known Pregnancy. Urine pregnancy test will only be completed on day of colonoscopy for all females age 14 and older per current standard anesthesia protocols. There have been no known reported animal or human studies that report the fetal effects of using polyethylene glycol. Per FDA, it is labeled as a category C drug in pregnancy. However, two studies , have reported successful treatment of constipation during pregnancy using polyethylene glycol solutions and did not find any significant effects or safety issues
研究组 & 干预措施
Polyethylene glycol 3350
干预措施: polyethylene glycol 3350 (Drug)
结局指标
主要结局
Efficacy of Cleanout
时间窗: At the end of the colonoscopy within 10-18 hours of completing the cleanout
Efficacy of cleanout utilizing Boston bowel preparation scale, completed by endoscopy fellow and staff at the end of the colonoscopy done within 10-18 hours after completion of the cleanout.
次要结局
- Electrolyte changes assessing basic metabolic profiles pre/post cleanout(30 days prior to 1 day after cleanout)
- Patient/parent satisfaction/tolerability/side effects utilizing questionnaire(1 day after cleanout)