Evaluation of Oral Simethicone With Low Volume Polyethylene Glycol Bowel Preparation During Colonoscopy

Study Overview
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Brief Summary
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An adequate bowel preparation has been well established to lead to a successful colonoscopy. Research has consistently demonstrated inadequate bowel preparation with lower adenoma detection rates. Over the years, endoscopy centers have changed the constituents of bowel preparation in light of new research. In 2006, 3 medical organizations recommended the use of polyethylene glycol (PEG) solution for bowel preparation. Initially, a 4 liter PEG solution was commonly used using a split dose regimen for bowel prep. However, many patients found that this large volume gave them side effects including bloating and cramping. Other studies showed that a low volume PEG solution with oral bisacodyl fared equally in terms of adequacy of bowel preparation. With the institution of lower volume PEG preparation our offices noted improved patient toleration, satisfaction, and clinical outcomes. However, multiple endoscopists have noticed an increased in intraluminal bubbles and foam with the low volume preparation. This can impair proper visualization of the bowel wall even with an adequate bowel preparation. The current standard of practice includes irrigation, lavage, and suctioning using a simethicone infused saline during the colonoscopy. Its property of reducing surface tension to help dissolve bubbles and clear the field of view is vital during the procedure. Furthermore, it does not dissolve into the blood stream and thereby, is considered rather safe. This study evaluates whether the addition of oral simethicone with the colonoscopy bowel preparation reduces bubbles and foam during the procedure using a randomized and controlled interventional study.

Detailed Description
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This prospective, multi-center, randomized, controlled, double (patient and endoscopist) blinded study is conducted at the Gastroenterology Consultants outpatient clinics and endoscopy centers in association with the University of Nevada-Reno School of Medicine. After obtaining signed informed consent, outpatients are recruited and randomized into 1 of 2 treatment groups; PEG3350-Bisacodyl with 200 mg liquid simethicone treatment and PEG3350-Bisacodyl treatment with inert placebo (water). The primary outcome includes reduction of bubbles using the intraluminal bubbles scale. Secondary outcomes include the evaluations of the numbers and types of polyps, numbers and types of masses detected, cecal insertion time, withdrawal time, adverse effects, and the adequacy of bowel prep using the Boston Bowel Prep scale.

Official Title
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Simethicone Pretreatment With Low-volume Polyethylene Glycol-3350 and Bisacodyl in an Effort to Improve Bowel Wall Visualization During Colonoscopy

Conditions
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Colonoscopy

Intervention / Treatment
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* Drug: Simethicone Solution
* Drug: Water


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eligible for outpatient elective colonoscopy Adult 18-80 years of age able to give consent. English speaking adults. Exclusion Criteria: History of bowel resection Uncontrolled hypertension Suspected bowel perforation Suspected bowel obstruction Indications for emergent/urgent colonoscopy Non-english speaking individuals

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Simethicone with PEG-3350 bisacodyl preparation<br>Treatment arm: 200 mg Simethicone in 3 mL of liquid formulation mixed with low volume PEG-3350 bisacodyl combination preparation. Bowel preparation taken as per directions including the evening before and the day of the procedure. | Drug: Simethicone Solution<br>* 200 mg of Simethicone in 3 mL of Simethicone Solution Formulation<br>|
| Placebo Comparator: Placebo with PEG-3350 bisacodyl preparation<br>Placebo arm: 3 mL of water mixed with low volume PEG-3350 bisacodyl combination preparation. Bowel preparation taken as per directions including the evening before and the day of the procedure. | Drug: Water<br>* 3 mL of water as placebo added to the bowel preparation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraluminal Bubbles Scale | I >90% of the mucosal circumference seen II 90%-75% of the mucosal seen without foam or bubbles not requiring irrigation III 74% to 50% of the mucosa is free of foam or bubbles. Required irrigation IV <50% of the mucosa seen free of foam or bubbles. Required irrigation | Data reported during colonoscopy. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Boston Bowel Preparation Scale |  | Data reported during colonoscopy. | 
| Cecal insertion time |  | Data reported during colonoscopy. | 
| Withdrawal time |  | Data reported during colonoscopy. | 
| Number of polyp |  | Data reported during colonoscopy. | 
| Type of polyp |  | Post colonoscopy pathology. Up until pathology data reporting. Estimated up to 2 weeks after colonoscopy. | 
| Type of masses |  | Post colonoscopy pathology. Up until pathology data reporting. Estimated up to 2 weeks after colonoscopy. | 
| Number of masses |  | Data reported during colonoscopy. | 
| Adverse effects |  | From the time of administration of the bowel preparation (day prior to colonoscopy) up until the time of the procedure preparation (pre-colonoscopy preparation). Estimated period of up to 24 hours. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bowel wall visualization, Intraluminal bubbles, Intraluminal foam, Simethicone