A Comparison of Bowel Prep Quality and Patient Satisfaction in Outpatients Undergoing Colonoscopy Preparation With Either a Standard Bowel Preparation or an Individualized Approach Using Sodium Picosulphatge/Magnesium Citrate or 4L Polyethylene Glycol Preparation Regimens
Overview
- Phase
- Phase 4
- Intervention
- Standard approach
- Conditions
- Bowel Cleansing Process
- Sponsor
- Clinical Hospital Colentina
- Enrollment
- 185
- Locations
- 3
- Primary Endpoint
- bowel cleansing
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
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.
Investigators
dr. Theodor Alexandru Voiosu
MD, gastroenterology resident
Clinical Hospital Colentina
Eligibility Criteria
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
Arms & Interventions
Standard approach
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
Intervention: Standard approach
Individualized approach
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)
Intervention: Individualized approach
Outcomes
Primary Outcomes
bowel cleansing
Time Frame: 24 hours
bowel cleansing as assessed during colonoscopy using 2 assessment scales (Boston bowel prep scale, and a 1-4 semiquantitative scale)
Secondary Outcomes
- patient comfort level during bowel cleansing(24 hours)