Evaluation of the Quality of Life of Patients Requiring Intestinal Cleansing Using Oral Medications to Imaging Procedure by Patient Reported Outcome
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 600
- 主要终点
- Boston scale for bowel cleansing
研究概览
简要总结
Objective: The primary objective of this study is to assess the quality of life of people treated with oral phosphate compared with polyethylene glycol + electrolytes to imaging procedures, according to the outcome variables reported by patients.
Type of study: A non-interventional observational analytic prospective cohort study.
Sample: We will include people who need bowel cleansing for the realization of imaging tests
Exposures: - oral sodium phosphate normal regimen
- Oral sodium phosphate with modified diet
- Polyethylene Glycol + electrolytes
Follow-up time: 8 days after the bowel preparation
Outcomes: Boston Scale measure Safety Differences between groups in blood test (Sodium, Potassium, Calcium)
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients which have order for an imaging procedure that requires bowel cleansing
- •Older than 18 years and younger than 65 years old
- •Accept to participate in this study
排除标准
- 未提供
研究组 & 干预措施
Oral Sodium Phosphate - Normal preparation
Oral sodium phospate exposure with special diet (Liquid)
干预措施: Oral Sodium Phosphate - Normal preparation (Drug)
Oral Sodium Phosphate - Modified preparation
Oral sodium phospate exposure with special diet (Liquid), but the participant can normally lunch the day before the test
干预措施: Oral sodium phosphate - Modified Preparation (Drug)
polyethylene glycol + Electrolytes
polyethylene glycol + Electrolytes exosure with special diet (Liquid)
干预措施: polyethylene glycol + Electrolytes (Drug)
结局指标
主要结局
Boston scale for bowel cleansing
时间窗: 2 days
次要结局
- Blood Sodium(8 days)
- Number of adverse events(8 days)
- Blood Calcium(8 days)
- Blood Phosphorus(8 days)
- Quality of life(8 days)
- Blood creatinine(8 days)
- Blood urea nitrogen (BUN)(8 days)
- Blood Potassium(8 days)