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NCT02536729 Clinical Trial

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

Bowel Preparation Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02536729
Other study ID # TRAVAD2015
Secondary ID
Status Not yet recruiting
Phase N/A
First received August 27, 2015
Last updated August 31, 2015
Start date September 2015

Study information
Verified date August 2015
Source Fundación Salutia
Contact n/a
Is FDA regulated No
Health authority Colombia: Institutional Review Board
Study type Observational

Clinical Trial 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)

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 600
Est. completion date
Est. primary completion date June 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• Oral Sodium Phosphate - Normal preparation

• Oral sodium phosphate - Modified Preparation

• polyethylene glycol + Electrolytes

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Fundación Salutia Tecnoquimicas S.A

Outcome
Type Measure Description Time frame Safety issue
Primary Boston scale for bowel cleansing 2 days No
Secondary Number of adverse events 8 days Yes
Secondary Quality of life Quality of life measured with EQ5D-3L scale 8 days No
Secondary Blood creatinine 8 days No
Secondary Blood urea nitrogen (BUN) 8 days No
Secondary Blood Sodium 8 days No
Secondary Blood Potassium 8 days No
Secondary Blood Calcium 8 days No
Secondary Blood Phosphorus 8 days No
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