The Effects of Moviprep With Simethicone on Colonic Bubbles

Study Overview
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Brief Summary
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The purpose of this study is to determine whether the administration of PEG along with simethicone will reduce the incidence of colonic bubbles that interfere with polyp detection.

Detailed Description
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evaluating if simethicone is better than placebo at decreasing gas in the colon at time of colonoscopy so that it is easier for the endoscopist to see polyps

Official Title
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The Effects of Moviprep With Simethicone on Colonic Bubbles

Conditions
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Bubbles in Colon at Time of Colonoscopy

Intervention / Treatment
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* Drug: simethicone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -Elective outpatients undergoing colonoscopy using split dose PEG-ELS with sodium ascorbate and ascorbic acid Exclusion Criteria: Unable or unwilling to give informed consent Age < 18 years Pregnant Breast feeding Established or suspected gastroparesis Pseudo-obstruction - established or suspected Severe constipation (< 1 BM a week) Bowel obstruction Greater than 50% resection of colon Chronic nausea or vomiting Consumed > 100% standard dose of PEG-ELS (i.e. more than 2L) G6PD deficiency PEG allergy Significant psychiatric illness

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: simethicone<br> | Drug: simethicone<br>* 400 mg simethicone at 6pm night prior to colonoscopy 400 mg simethicone 4 hours before colonoscopy<br>* Other names: Phazyme®-166 Maximum Strength Softgels®;|
| No Intervention: no simethicone<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy - Entire colon | Successful cleansing defined as score or excellent or good Unsuccessful cleansing defined as score of fair or inadequate | At time of colonoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy - Right colon | Successful cleansing defined as score or excellent or good Unsuccessful cleansing defined as score of fair or inadequate | At time of colonoscopy | 
| Adenoma detection | Defined as number of adenoma/patient Secondarily evaluate % of patients with at least 1 adenoma | at time of colonoscopy | 
| Flushing | Defined as need for any (1, 2, or 3) flushing • 0 = none, 1 = <50 ml, 2 = 50-100 ml, 3 = >100 ml | at time of colonoscopy | 
| Tolerance | Prep completion • Completion defined as consuming > 90% Sleep Primary definition as quality of sleep Also evaluate duration of sleep Overall satisfaction Use visual analogue (Likert) scale Adverse events - nausea, vomiting, abdominal pain, bloating, light-headedness Primary is incidence Secondary is severity using Likert scale | during prep ingestion | 
| Safety | Vitals with orthostatic measures (BP, Pulse) day of colonoscopy Physical exam | at time of colonoscopy |