A Multicenter Single-blind Comparison Between Standard and Individualized Approach in Bowel Preparation Before Colonoscopy

Clinical Hospital Colentina

Status and phase: Completed; Phase 4

Conditions: Colonoscopy; Bowel Cleansing Process

Treatments: Drug: Standard approach; Drug: Individualized approach

Study type: Interventional

Funder types: Other

Identifiers

NCT02024022

COL GASTRO 4

Details and patient eligibility

About

This study aims to compare a standard approach to bowel preparation for colonoscopy (using sodium picosulphate/magnesium citrate or 4lPEG) to an individualized approach where patients are assigned a specific regimen of either sodium picosulphate/magnesium citrate or 4lPEG depending on patient-related factors. The study aims to compare patient-related outcomes such as comfort levels during bowel cleansing and physician-related outcomes such as bowel prep quality in the two study groups.

Enrollment: 185 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• all patients > 18 years of age undergoing elective colonoscopy on an outpatient basis

Exclusion criteria

• refusal to sign informed consent
• pregnancy
• advance kidney, liver or heart disease
• suspicion of malignant / benign stenosis of the digestive tract

Trial design

185 participants in 2 patient groups

Standard approach

Active Comparator group

Description:

patients will be randomized to one of the 2 currently used bowel preparation regimens in our clinic: * 4L split polyethylene glycol solution * split magnesium citrate/sodium picosulphate preparation regimen

Treatment:

Drug: Standard approach

Individualized approach

Experimental group

Description:

patients will receive either the 4L split polyethylene glycol bowel prep regimen or the sodium picosulphate/magnesium citrate split prep regimen according to personal characteristics assessed using a self-administered questionnaire (including bowel habits, the preference for large-volume preparation and education level)

Treatment:

Drug: Individualized approach