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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02536729
Recruitment Status : Unknown
Verified August 2015 by Fundación Salutia.
Recruitment status was:  Not yet recruiting
First Posted : September 1, 2015
Last Update Posted : September 1, 2015
Tecnoquimicas S.A
Information provided by (Responsible Party):
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)

Condition or disease Intervention/treatment
Bowel Preparation Drug: Oral Sodium Phosphate - Normal preparation Drug: Oral sodium phosphate - Modified Preparation Drug: polyethylene glycol + Electrolytes

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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : September 2015
Estimated Primary Completion Date : June 2016

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Oral Sodium Phosphate - Normal preparation
Oral sodium phospate exposure with special diet (Liquid)
Drug: Oral Sodium Phosphate - Normal preparation
Other Name: Travad

Oral Sodium Phosphate - Modified preparation
Oral sodium phospate exposure with special diet (Liquid), but the participant can normally lunch the day before the test
Drug: Oral sodium phosphate - Modified Preparation
Other Name: Travad

polyethylene glycol + Electrolytes
polyethylene glycol + Electrolytes exosure with special diet (Liquid)
Drug: polyethylene glycol + Electrolytes
Other Name: PEG

Primary Outcome Measures :
  1. Boston scale for bowel cleansing [ Time Frame: 2 days ]

Secondary Outcome Measures :
  1. Number of adverse events [ Time Frame: 8 days ]
  2. Quality of life [ Time Frame: 8 days ]
    Quality of life measured with EQ5D-3L scale

  3. Blood creatinine [ Time Frame: 8 days ]
  4. Blood urea nitrogen (BUN) [ Time Frame: 8 days ]
  5. Blood Sodium [ Time Frame: 8 days ]
  6. Blood Potassium [ Time Frame: 8 days ]
  7. Blood Calcium [ Time Frame: 8 days ]
  8. Blood Phosphorus [ Time Frame: 8 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults who are in diagnostic centers, which have order for an imaging procedure that requires intestinal cleansing conducted.

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
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Responsible Party: Fundación Salutia Identifier: NCT02536729    
Other Study ID Numbers: TRAVAD2015
First Posted: September 1, 2015    Key Record Dates
Last Update Posted: September 1, 2015
Last Verified: August 2015