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Evaluation of the Quality of Life of Patients Requiring Intestinal Cleansing Using Oral Medications to Imaging Procedure by Patient Reported Outcome

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02536729
Enrollment
600
Registered
2015-09-01
Start date
2015-09-30
Completion date
Unknown
Last updated
2015-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bowel Preparation

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)

Interventions

DRUGOral Sodium Phosphate - Normal preparation
DRUGOral sodium phosphate - Modified Preparation
DRUGpolyethylene glycol + Electrolytes

Sponsors

Tecnoquimicas S.A
CollaboratorUNKNOWN
Fundación Salutia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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

Design outcomes

Primary

MeasureTime frame
Boston scale for bowel cleansing2 days

Secondary

MeasureTime frameDescription
Quality of life8 daysQuality of life measured with EQ5D-3L scale
Blood creatinine8 days
Blood urea nitrogen (BUN)8 days
Number of adverse events8 days
Blood Potassium8 days
Blood Calcium8 days
Blood Phosphorus8 days
Blood Sodium8 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026