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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Bowel Cleansing Process, Colonoscopy

Intervention / Treatment
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* Drug: Standard approach
* Drug: Individualized approach


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard approach<br>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 | Drug: Standard approach<br>* bowel cleansing with either 4L PEG or sodium picosulphate/magnesium citrate<br>|
| Experimental: Individualized approach<br>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) | Drug: Individualized approach<br> <br> * Other names: 4 L polyethylene glycol or sodium picosulphate / magnesium citrate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bowel cleansing | bowel cleansing as assessed during colonoscopy using 2 assessment scales (Boston bowel prep scale, and a 1-4 semiquantitative scale) | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient comfort level during bowel cleansing | patient pain levels on a 0-10 visual analogue scale during the bowel cleansing process | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colonoscopy, bowel cleansing, polyethylene glycol, sodium picosulphate / magnesium citrate