Personalized Colonoscopy Preparation for Patients With Risk Factors for Inadequate Preparation

Study Overview
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Brief Summary
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Adequate bowel preparation is one of the most important quality measures in colonoscopy. Previous studies identified several factors associated with inadequate bowel preparation (IBP). No study has attempted to assign a different regimen to patients based on the presence of risk factors for inadequate bowel preparation. The aim of the study is to check if a personalized bowel preparation regimen based on risk factors for IBP, will lead to an overall improvement in bowel preparation during colonoscopy.

Official Title
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Personalized Colonoscopy Preparation for Patients With Risk Factors for Inadequate Preparation: A Randomized Control Trial

Conditions
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Inadequate Preparation for Colonoscopy; Personalized Colonoscopy Preparation

Intervention / Treatment
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* Drug: Sodium Picosulfate / Magnesium Oxide / Citric Acid in two split doses + one dose of polyethylene glycol + two Bisacodyl tablets day before the procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: previous IBP concurrent medical conditions (e.g. diabetes, constipation) medications (e.g. opioids and tricyclic antidepressants) Exclusion Criteria: previous colonic resection patients with IBD active CRC chronic kidney disease at any stage congestive heart failure at any stage liver cirrhosis

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

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional arm (group A)<br>Patients with risk factors for IBP who will receive intensified bowel preparation | Drug: Sodium Picosulfate / Magnesium Oxide / Citric Acid in two split doses + one dose of polyethylene glycol + two Bisacodyl tablets day before the procedure<br>* Bowel preparation<br>* Other names: Sodium Picosulfate / Magnesium Oxide / Citric Acid in two split doses;|
| Active Comparator: Control arm (group B)<br>Patients with risk factors for IBP who will receive standard bowel preparation | Drug: Sodium Picosulfate / Magnesium Oxide / Citric Acid in two split doses + one dose of polyethylene glycol + two Bisacodyl tablets day before the procedure<br>* Bowel preparation<br>* Other names: Sodium Picosulfate / Magnesium Oxide / Citric Acid in two split doses;|
| Active Comparator: Control arm (group c)<br>Patients without risk factors for IPB who will receive standard bowel preparation | Drug: Sodium Picosulfate / Magnesium Oxide / Citric Acid in two split doses + one dose of polyethylene glycol + two Bisacodyl tablets day before the procedure<br>* Bowel preparation<br>* Other names: Sodium Picosulfate / Magnesium Oxide / Citric Acid in two split doses;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved bowel preparation | Boston Bowel Preparation Scale at index colonoscopy will be measured. The grading is between 1 and 3 for each segment of colon (ascending, transverse, descending) where 1 is poor and 3 is excellent (subscale). The final score is between 3 and 9 summing up the scores for each segment. | Index colonoscopy |