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

August 31, 2015 updated by: Fundación Salutia

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)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

600

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Oral Sodium Phosphate - Normal preparation
Oral sodium phospate exposure with special diet (Liquid)
Drug: Oral Sodium Phosphate - Normal preparation
Other Names:
  • 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 Names:
  • Travad
polyethylene glycol + Electrolytes
polyethylene glycol + Electrolytes exosure with special diet (Liquid)
Drug: polyethylene glycol + Electrolytes
Other Names:
  • PEG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Boston scale for bowel cleansing
Time Frame: 2 days
2 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of adverse events
Time Frame: 8 days
8 days
Quality of life
Time Frame: 8 days
Quality of life measured with EQ5D-3L scale
8 days
Blood creatinine
Time Frame: 8 days
8 days
Blood urea nitrogen (BUN)
Time Frame: 8 days
8 days
Blood Sodium
Time Frame: 8 days
8 days
Blood Potassium
Time Frame: 8 days
8 days
Blood Calcium
Time Frame: 8 days
8 days
Blood Phosphorus
Time Frame: 8 days
8 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Salutia

Collaborators

Tecnoquimicas S.A

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

August 27, 2015

First Submitted That Met QC Criteria

August 31, 2015

First Posted (Estimate)

September 1, 2015

Study Record Updates

Last Update Posted (Estimate)

September 1, 2015

Last Update Submitted That Met QC Criteria

August 31, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • TRAVAD2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bowel Preparation

Clinical Trials on Oral Sodium Phosphate - Normal preparation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe