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

• Conditions: Bowel Preparation
• Interventions: Drug: Oral Sodium Phosphate - Normal preparation; Drug: Oral sodium phosphate - Modified Preparation; Drug: polyethylene glycol + Electrolytes

• Registration Number: NCT02536729
• Lead Sponsor: Fundación Salutia

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)

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-08
• Study First Submitted: 2015-08-27
• Study First Submitted QC: 2015-08-31
• Last Update Submitted: 2015-08-31
• Study Start: 2015-09
• Study First Posted: 2015-09-01
• Last Update Posted: 2015-09-01
• Primary Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Oral Sodium Phosphate - Normal preparation	Oral Sodium Phosphate - Normal preparation	Oral sodium phospate exposure with special diet (Liquid)
Oral Sodium Phosphate - Modified preparation	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	polyethylene glycol + Electrolytes exosure with special diet (Liquid)

Primary Outcome Measures

Name	Time	Method
Boston scale for bowel cleansing	2 days

Secondary Outcome Measures

Name	Time	Method
Blood Sodium	8 days
Number of adverse events	8 days
Blood Calcium	8 days
Blood Phosphorus	8 days
Quality of life	8 days	Quality of life measured with EQ5D-3L scale
Blood creatinine	8 days
Blood urea nitrogen (BUN)	8 days
Blood Potassium	8 days