Evaluation of Reduced-volume PEG Bowel Preparation Administered the Same Day of Colonoscopy

Study Overview
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Brief Summary
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The conventional total dose of 4 L of polyethylene glycol (PEG) given the day before the procedure is safe and effective. It has been the standard cleansing regimen for the last 25 years. To overcome the difficulty in completing the bowel preparation due to large volume and/or taste, reduced-volume (mixed) bowel preparation of bisacodyl and 2 L of PEG have been shown to provide adequate colon cleansing and better tolerability. LoVol-esse is a reduced-volume PEG-based bowel preparation to be used in combination with bisacodyl and designed to improve patient tolerability and attitude toward bowel cleansing prior to colonoscopy thanks to the reduced volume and improved taste. The present study is intended to compare the new dosing regimen of the bowel lavage solution given the same day compared with standard PEG formulation (SELG 1000) given the day before colonoscopy.

Detailed Description
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A polyethylene glycol (PEG) electrolyte lavage solution (PEG-ELS) was originally developed in 1980 by the Fordtran group as isosmotic preparation for minimal water and electrolyte exchange with plasma to ensure safe cleansing of the bowel through a mechanical effect of large-volume lavage. The conventional total dose of 4 L given the day before the procedure is safe and effective and has been the standard cleansing regimen for the last 25 years. To overcome the difficulty in completing the bowel preparation due to large volume and/or taste, reduced-volume (mixed) bowel preparation of bisacodyl and 2 L of PEG-ELS have been shown to provide adequate colon cleansing and better tolerability. In the last recent years, time of preparation has been demonstrated to be a critical factor for bowel preparation for colonoscopy. Several studies have demonstrated that reducing the time interval between the completion of bowel preparation and the exam improves colon cleansing compared with standard dose regimen of the PEG-electrolyte solution given the day before colonoscopy. At the same time manufacturers have tried to improve the taste and palatability of PEG formulations by adding suitable ingredients such as ascorbic acid or citric acid. LoVol-esse is a reduced-volume PEG-based bowel preparation to be used in combination with bisacodyl and designed to improve patient tolerability and attitude toward bowel cleansing prior to colonoscopy thanks to the reduced volume and improved taste. The present study is intended to compare the new dosing regimen of the bowel lavage solution given the same day compared with standard PEG formulation (SELG 1000) given the day before colonoscopy. The results of this study will tells us if the last-hour preparation is effective and offers adequate tolerability and compliance to be adopted in clinical practice.

Official Title
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Evaluation of Reduced-volume PEG Bowel Preparation Administered the Same Day of Colonoscopy

Conditions
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Colonic Polyps, Cancer Colon, Inflammatory Bowel Disease

Intervention / Treatment
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* Drug: polyethylene glycol (PEG)
* Drug: PEG low volume with bisacodyl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: both sexes aged between 18 and 85 yr undergoing a complete colonoscopy Exclusion Criteria: known or suspected gastrointestinal obstruction or perforation toxic megacolon major colonic resection pregnant or at risk of becoming pregnant women lactating women inability to comprehend the full nature and purpose of the study no signed informed consent prior to inclusion in the study known or suspected hypersensitivity to the active principles or other ingredients history of anaphylaxis to drugs or allergic reactions in general

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: polyethylene glycol (PEG)<br> | Drug: polyethylene glycol (PEG)<br>* SELG-ESSE 1000 4 L: 2L THE DAY BEFORE OF COLONOSCOPY AND 2 L THE SAME DAY OF COLONOSCOPY<br>|
| Experimental: PEG low volume with bisacodyl<br> | Drug: PEG low volume with bisacodyl<br>* Lovolesse + Lovoldyl 2L of Lovolesse with 2 or 3 tablets of bisacodyl the day before of colonoscopy or 2L of Lovolesse with 2 or 3 tablets of bisacodyl the same day of colonoscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the overall quality of bowel preparation | Quality of preparation will be graded according to the Ottawa Scale. | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety | incidence and severity of the following GI unexpected adverse events: nausea, abdominal bloating, abdominal pain/cramps on a 5-point Likert scale | 4 months | 
| compliance | Proportion of patients able to: drink < 75% of the solution (poor compliance) drink at least 75% of the solution (good compliance) drink all the solution (optimal compliance) | 4 months |