Polyethylene Glycol Powder Solution vs Senna for Bowel Preparation for Colonoscopy in Children: A Prospective, Randomized, Investigator-Blinded Trial.
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Efficacy of Colon Preparation
研究概览
简要总结
The primary objective of this study is to determine whether Miralax results in a more efficacious preparation as compared to senna for pediatric colonoscopy.
详细描述
Study subjects will be randomized in two groups: Group one will receive 1.5 g/kg of Miralax orally the day before procedure and one day of clear liquid diet, while subjects in Group 2 will receive two doses of senna the day before procedure with two days of liquid diet (one day full liquid and one day clear liquid diet). On the day of the procedure parents/subjects will complete a questionnaire regarding prep compliance and adverse events. Electrolytes will be obtained prior to colonoscopy to monitor for electrolyte imbalance. Endoscopists will assess preparation for colonoscopy using validated cleanliness scale (Aronchick scale).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 6 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects age 6-21 yrs for senna, PEG-P groups
- •Subjects age 13-21 yrs for NaP group
- •First time colonoscopy
- •Patient weight <70 kg for PEG-P group (to not exceed 51 grams/dose)
排除标准
- •Chronic renal, liver, or heart failure
- •Chronic constipation
- •Patients on the GI inpatient or consult service.
- •Subjects taking senna or PEG on a regular basis for laxative reasons.
- •Pregnant or lactating females
研究组 & 干预措施
1, Miralax
Miralax colonoscopy preparation
干预措施: polyethylene glycol, senna (Drug)
2, senna
Senna colonoscopy preparation
干预措施: polyethylene glycol, senna (Drug)
结局指标
主要结局
Efficacy of Colon Preparation
时间窗: The outcome measure will be assessed once one day after the completion of colonoscopy preparation
Percentage of patients with excellent or good colonoscopy preparation. The efficacy of preparation is measured by using a validated colon cleanliness scale which has 5 different levels (Aronchik scale). Levels 1 and 2, which encompass excellent and good colonoscopy preparation, are routinely recognized as adequate preparation allowing for successful completion of colonoscopy. Levels 3-5 describe incomplete or poor preparation. These levels are associated with significant residual stool encountered at the time of colonoscopy.
次要结局
- Proportion of Patients With Abnormal Electrolyte Levels(The outcome measure will be assessed once one day after the completion of colonoscopy preparation)
研究者
Petar Mamula
Director, Endoscopy
Children's Hospital of Philadelphia