Evaluation of the Quality of Life of Patients Requiring Intestinal Cleansing Using Oral Medications to Imaging Procedure by Patient Reported Outcome
1 other identifier
observational
600
0 countries
N/A
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 27, 2015
CompletedFirst Posted
Study publicly available on registry
September 1, 2015
CompletedStudy Start
First participant enrolled
September 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedSeptember 1, 2015
August 1, 2015
9 months
August 27, 2015
August 31, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Boston scale for bowel cleansing
2 days
Secondary Outcomes (8)
Number of adverse events
8 days
Quality of life
8 days
Blood creatinine
8 days
Blood urea nitrogen (BUN)
8 days
Blood Sodium
8 days
- +3 more secondary outcomes
Study Arms (3)
Oral Sodium Phosphate - Normal preparation
Oral sodium phospate exposure with special diet (Liquid)
Oral Sodium Phosphate - Modified preparation
Oral sodium phospate exposure with special diet (Liquid), but the participant can normally lunch the day before the test
polyethylene glycol + Electrolytes
polyethylene glycol + Electrolytes exosure with special diet (Liquid)
Interventions
Eligibility Criteria
Adults who are in diagnostic centers, which have order for an imaging procedure that requires intestinal cleansing conducted.
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fundación Salutialead
- Tecnoquimicas S.Acollaborator
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 27, 2015
First Posted
September 1, 2015
Study Start
September 1, 2015
Primary Completion
June 1, 2016
Last Updated
September 1, 2015
Record last verified: 2015-08