Evaluation of the Quality of Life of Patients Requiring Intestinal Cleansing Using Oral Medications to Imaging Procedure by Patient Reported Outcome
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 600
- Primary Endpoint
- Boston scale for bowel cleansing
Study Overview
Brief Summary
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)
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Exclusion Criteria
- Not provided
Arms & Interventions
Oral Sodium Phosphate - Normal preparation
Oral sodium phospate exposure with special diet (Liquid)
Intervention: 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
Intervention: Oral sodium phosphate - Modified Preparation (Drug)
polyethylene glycol + Electrolytes
polyethylene glycol + Electrolytes exosure with special diet (Liquid)
Intervention: polyethylene glycol + Electrolytes (Drug)
Outcomes
Primary Outcomes
Boston scale for bowel cleansing
Time Frame: 2 days
Secondary Outcomes
- 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)