Evaluation of the Quality of Life of Patients Requiring Intestinal Cleansing Using Oral Medications to Imaging Procedure by Patient Reported Outcome
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)
研究概览
地位
条件
研究类型
注册 (预期的)
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- 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
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Oral Sodium Phosphate - Normal preparation
Oral sodium phospate exposure with special diet (Liquid)
|
其他名称:
|
|
Oral Sodium Phosphate - Modified preparation
Oral sodium phospate exposure with special diet (Liquid), but the participant can normally lunch the day before the test
|
其他名称:
|
|
polyethylene glycol + Electrolytes
polyethylene glycol + Electrolytes exosure with special diet (Liquid)
|
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Boston scale for bowel cleansing
大体时间:2 days
|
2 days
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of adverse events
大体时间:8 days
|
8 days
|
|
|
Quality of life
大体时间:8 days
|
Quality of life measured with EQ5D-3L scale
|
8 days
|
|
Blood creatinine
大体时间:8 days
|
8 days
|
|
|
Blood urea nitrogen (BUN)
大体时间:8 days
|
8 days
|
|
|
Blood Sodium
大体时间:8 days
|
8 days
|
|
|
Blood Potassium
大体时间:8 days
|
8 days
|
|
|
Blood Calcium
大体时间:8 days
|
8 days
|
|
|
Blood Phosphorus
大体时间:8 days
|
8 days
|
合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- TRAVAD2015
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