Single Center Comparison of 4 FDA Approved, Commercially Available Bowel Purgatives for Colonoscopy

Study Overview
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Brief Summary
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This will be a 4-way comparison to prospectively evaluate the efficacy and patient tolerability of four commercially available bowel preparations among patients undergoing colonoscopy for screening and surveillance in a single tertiary academic medical center.

Detailed Description
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We will randomize 300 consecutive patients undergoing colonoscopy for screening or surveillance purposes to receive one of four bowel purgatives. These purgatives include Split dose 4 liter polyethylene glycol with electrolytes (PEG+E): Brand name GoLytely Split dose 2 liter polyethylene glycol with ascorbic acid (PEG+Asc): Brand name: MoviPrep Split dose sodium picosulfate, magnesium oxide, and anhydrous citric acid (P+MC): Brand name Prepopik Split dose sodium sulfate, magnesium sulfate, and potassium sulfate solution (sulfate): Brand name Suprep

Official Title
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Comparison of Efficacy and Patient Tolerability of Four Commercially Available Bowel Purgatives for Screening and Surveillance Colonoscopy: A Single Tertiary Medical Center Experience.

Conditions
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Patients Undergoing Screening or Surveillance Colonoscopy

Intervention / Treatment
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* Drug: PEG+E
* Drug: PEG+Asc
* Drug: P+MC
* Drug: sulfate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or greater Ability to understand and complete questionnaires Ability to speak and read English Willingness to participate in study Colonoscopy is being performed for routine screening (i.e. no prior personal history of polyps or cancer) or surveillance (i.e. follow up for a personal history of polyps) purposes Exclusion Criteria: Previous bowel resection of any kind (small or large bowel) End stage renal disease (ESRD) Contraindication to bowel purgative Necessity for inpatient admission to receive bowel preparation for any reason Currently taking any narcotic/opiate pain or anticholinergic medication (since these may predispose to higher colon stool burden at baseline) Currently taking stool softeners (e.g. Miralax, Amitiza, Linzess, lactulose) or stimulant laxatives (e.g. Dulcolax) Subject did not follow appropriate dosing instructions for bowel purgative Colonoscopy is being performed to evaluate a clinical symptom such as rectal bleeding, constipation, abdominal pain, or diarrhea History of colon polyposis syndrome Personal history of inflammatory bowel disease History of inadequate colon preparation on any prior colonoscopies Patient is pregnant

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PEG+E<br>Split dose 4 liter polyethylene glycol with electrolytes | Drug: PEG+E<br>* Split dose 4 liter polyethylene glycol with electrolytes<br>* Other names: Golytely;|
| Active Comparator: PEG+Asc<br>Split dose 2 liter polyethylene glycol with ascorbic acid | Drug: PEG+Asc<br>* Split dose 2 liter polyethylene glycol with ascorbic acid<br>* Other names: MoviPrep;|
| Active Comparator: P+MC<br>Split dose sodium picosulfate, magnesium oxide, and anhydrous citric acid | Drug: P+MC<br>* Split dose sodium picosulfate, magnesium oxide, and anhydrous citric acid<br>* Other names: Suprep;|
| Active Comparator: sulfate<br>Split dose sodium sulfate, magnesium sulfate, and potassium sulfate solution | Drug: sulfate<br>* Split dose sodium sulfate, magnesium sulfate, and potassium sulfate solution<br>* Other names: Prepopik;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of bowel cleansing according to the Boston Bowel Preparation Score (BPPS) |  | Patient outcome will be assessed at the time of the colonoscopy by the performing physician and ducomentation of this outcome will occur within 24 hours of the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient tolerability and satisfaction | Will be assessed using a previously studied satisfaction questionnaire (7 items) | Outcome of satisfaction will be assessed on a single survey that the patient will provide the day of their colonoscopy and will be recorded by study personnel up to 30 days thereafter |