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Clinical Trials/NCT02536729
NCT02536729
Unknown
N/A

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

Fundación Salutia0 sites600 target enrollmentSeptember 2015

Overview

Phase
N/A
Intervention
Oral Sodium Phosphate - Normal preparation
Conditions
Bowel Preparation
Sponsor
Fundación Salutia
Enrollment
600
Primary Endpoint
Boston scale for bowel cleansing
Last Updated
10 years ago

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)

Registry
clinicaltrials.gov
Start Date
September 2015
End Date
June 2016
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Fundación Salutia
Responsible Party
Sponsor

Eligibility Criteria

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

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

polyethylene glycol + Electrolytes

polyethylene glycol + Electrolytes exosure with special diet (Liquid)

Intervention: polyethylene glycol + Electrolytes

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)

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