Bowel Preparation Clinical Trial
Verified date | August 2015 |
Source | Fundación Salutia |
Contact | n/a |
Is FDA regulated | No |
Health authority | Colombia: Institutional Review Board |
Study type | Observational |
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)
Status | Not yet recruiting |
Enrollment | 600 |
Est. completion date | |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Fundación Salutia | Tecnoquimicas S.A |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Boston scale for bowel cleansing | 2 days | No | |
Secondary | Number of adverse events | 8 days | Yes | |
Secondary | Quality of life | Quality of life measured with EQ5D-3L scale | 8 days | No |
Secondary | Blood creatinine | 8 days | No | |
Secondary | Blood urea nitrogen (BUN) | 8 days | No | |
Secondary | Blood Sodium | 8 days | No | |
Secondary | Blood Potassium | 8 days | No | |
Secondary | Blood Calcium | 8 days | No | |
Secondary | Blood Phosphorus | 8 days | No |
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