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

Fundación Salutia

Status: Unknown

Conditions: Bowel Preparation

Treatments: Drug: Oral sodium phosphate - Modified Preparation; Drug: Oral Sodium Phosphate - Normal preparation; Drug: polyethylene glycol + Electrolytes

Study type: Observational

Funder types: Other

Identifiers

NCT02536729

TRAVAD2015

Details and patient eligibility

About

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)

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

600 participants in 3 patient groups

Oral Sodium Phosphate - Normal preparation

Description:

Oral sodium phospate exposure with special diet (Liquid)

Treatment:

Drug: Oral Sodium Phosphate - Normal preparation

Oral Sodium Phosphate - Modified preparation

Description:

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

Treatment:

Drug: Oral sodium phosphate - Modified Preparation

polyethylene glycol + Electrolytes

Description:

polyethylene glycol + Electrolytes exosure with special diet (Liquid)

Treatment:

Drug: polyethylene glycol + Electrolytes