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

NCT ID: NCT02536729

Last Updated: 2015-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Brief Summary

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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

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Conditions

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Bowel Preparation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Oral Sodium Phosphate - Normal preparation

Oral sodium phospate exposure with special diet (Liquid)

Oral Sodium Phosphate - Normal preparation

Intervention Type DRUG

Oral Sodium Phosphate - Modified preparation

Oral sodium phospate exposure with special diet (Liquid), but the participant can normally lunch the day before the test

Oral sodium phosphate - Modified Preparation

Intervention Type DRUG

polyethylene glycol + Electrolytes

polyethylene glycol + Electrolytes exosure with special diet (Liquid)

polyethylene glycol + Electrolytes

Intervention Type DRUG

Interventions

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Oral Sodium Phosphate - Normal preparation

Intervention Type DRUG

Oral sodium phosphate - Modified Preparation

Intervention Type DRUG

polyethylene glycol + Electrolytes

Intervention Type DRUG

Other Intervention Names

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Travad Travad PEG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tecnoquimicas S.A

UNKNOWN

Sponsor Role collaborator

Fundación Salutia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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TRAVAD2015

Identifier Type: -

Identifier Source: org_study_id

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