Bowel Cleansing for Colonoscopy: Comparison Between a Same Day Low-Volume Preparation and a Conventional 4L Split One

Study Overview
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Brief Summary
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The present study is intended to evaluate the effectiveness, tolerability, compliance, and feasibility of the low volume bowel preparation, bisacodyl tablets followed by 2L Polyethylene glycol (PEG) with citrate and simethicone (CS) given the same day of colonoscopy, vs the standard 4L split PEG solution.

Detailed Description
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Eligible patients will be informed about the aims, procedures, benefits and possible risks of the study prior to sign the informed consent form from day -30 to day-3. They will provide medical history and undergo a physical examination. Patients will be evaluated by a Physician other than the blind Endoscopist. The same responsible person will instruct the patients about administration procedures in both oral and written form. The patients will be assigned to receive one of the dosing schedule bowel preparation according to a computer generated block-randomisation list. Patients will take the study treatment at home according to the given instructions. Patients will return to the clinic for colonoscopy. The colonoscopy will be performed by an Endoscopist who will be unaware of the bowel dose-regimen preparation taken by the patient. Completed colonoscopic exam will be performed with time recorded (intubation and withdrawal from ceacum). The unblind Investigator will ask the patients about safety, tolerability, overall acceptance and compliance.

Official Title
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Bowel Cleansing for Colonoscopy: Comparison Between a Same Day Low-Volume Preparation and a Conventional 4L Split One. A Randomized, Observer-blind, Parallel Group, Comparative Study.

Conditions
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Colonoscopy

Intervention / Treatment
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* Drug: Bisacodyl plus PEG-CS
* Drug: PEG 4 litres split


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Out-patients undergoing a complete colonoscopy Patient written informed consent Exclusion Criteria: Pregnant or lactating women or at a risk of becoming pregnant Known or suspected gastrointestinal obstruction or perforation; toxic megacolon; major colonic resection Known or suspected hypersensitivity to the active principle and/or formulations' ingredients

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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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 |
| --- | --- |
| Active Comparator: PEG 4 litres split<br>Polyethylene glycol with electrolytes (PEG) | Drug: PEG 4 litres split<br>* the day before colonoscopy: 2 litres of PEG the morning of colonoscopy: 2 litres of PEG starting 5 hours before the examination<br>* Other names: SELG 1000;|
| Experimental: Bisacodyl plus PEG-CS<br>Bisacodyl plus PEG-CS: Bisacodyl plus Polyethylene glycol with citrate and simethicone (PEG-CS) | Drug: Bisacodyl plus PEG-CS<br>* the day before colonoscopy: 3-4 bisacodyl tablets (according to patient bowel habit) at bedtime the morning of colonoscopy: PEG-CS (2 litres) starting 5 hours before the exam<br>* Other names: LOVOLdyl plus LOVOLesse;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy | Evaluation of the quality of bowel preparation according to the Ottawa Scale | 20 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy | Evaluation of the mucosal visibility according to a 3 point scale (0-2) | 20 min | 
| Efficacy | Adenoma detection rate | 20 min | 
| Safety | Recording of all adverse events occurred during the study by patient questioning | 24 hours | 
| Tolerability | rate of patients in the two groups who developed GI symptoms related to bowel preparation | 24 hours | 
| Acceptability | willingness to repeat the preparation | 24 hours | 
| Compliance | rate of patient with intake of at least 75% of bowel preparation | 24 hours |