A Trial Comparing Split-Dose Miralax With Amitiza Pretreatment Versus Dulcolax Pretreatment Versus Golytely for Bowel Cleansing Prior to Colonoscopy

Study Overview
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Brief Summary
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Miralax (PEG 3350) has been shown to be a safe and uncomplicated bowel preparation prior to colonoscopy in pediatric populations. This study seeks to confirm the efficacy of this bowel cleansing regimen in adults and to determine the benefit of adding a pretreatment medication to this bowel preparation. The tolerability of Miralax will hopefully improve patient satisfaction with colonoscopy and decrease their reluctance to be screened because of the uncomfortable taste and side effects of bowel preparation regimens.

Official Title
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A Randomized, Blinded Trial Comparing Miralax With Amitiza Pretreatment Versus Miralax With Dulcolax Pretreatment Versus Miralax Alone Without Pretreatment Versus Golytely for Bowel Cleansing Prior to Colonoscopy

Conditions
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Colonoscopy

Intervention / Treatment
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* Drug: Miralax (PEG 3350)
* Drug: Amitiza (Lubiprostone)
* Drug: Dulcolax (Bisacodyl)
* Drug: Golytely (polyethylene glycol)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult patients referred to our clinic for average or increased risk screening for colorectal cancer Exclusion Criteria: elevated serum creatinine (Men >1.4mg/dL, Women >1.3mg/dL) previous diagnosis of congestive heart failure history of bowel obstruction history of solid organ transplant current pregnancy lactating mother participants allergic to either polyethylene glycol (Miralax), lubiprostone (Amitiza), or bisacodyl (Dulcolax)

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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Accepts Healthy Volunteers

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: Miralax plus Amitiza<br>106 patients randomized to Miralax plus Amitiza will take one 24mcg gelcap of Amitiza at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy. | Drug: Amitiza (Lubiprostone)<br>* Amitiza 24mcg gelcap<br>|
| Active Comparator: Miralax plus Dulcolax<br>107 patients randomized to Miralax plus Dulcolax will take two 5mg tablets of Dulcolax at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy. | Drug: Dulcolax (Bisacodyl)<br>* Bisacodyl 5mg tab x2<br>|
| Active Comparator: Miralax<br>106 patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy. | Drug: Miralax (PEG 3350)<br>* Miralax 255gm bottle<br>|
| Active Comparator: Golytely (polyethylene glycol)<br>106 patients will take 1 gallon of golytley (Polyethylene glycol) and drink 1/2 of the solution at 4 p.m. The remaining 1/2 of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy | Drug: Golytely (polyethylene glycol)<br>* Golytely 1 gallon<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Cleanliness of the Prep as Measured by the Ottawa Scale | Bowel cleansing was evaluated with the Ottawa bowel preparation scale by each endoscopist during the endoscopy. Neither the endoscopist nor the endoscopy nurse was aware of the bowel preparation used prior to the colonoscopy. The Ottawa bowel preparation scale is a validated tool and was used in this study to provide a reliable quality assessment of the bowel preparation used for colonoscopy. This validated scale rates each section of the colon, the right, the mid, and the rectosigmoid colon, on a 5-point scale (0-4), as well as a global 3-point rating for overall colonic fluid (0-2). The total score ranges from 0 to 14. An excellent preparation with little fluid would score 0-3, a good preparation 4-6, while scores higher than 7 would indicate progressively worsening bowel preparations. A completely unprepared colon would score 11-14, depending on the amount of colonic fluid. | measured at the time of colonoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction With the Prep Measured by 5 Point Likert Scale | patient satisfaction based on a Likert Scale from 0-5 (5 being completely satisfied and 0 being not satisfied) | measured at check in to colonoscopy | 
| Procedure Time | total colonoscopy procedure time | measured at the time of colonoscopy | 
| Polyps Detected | Number of polyps | measured at the time of colonoscopy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Efficacy of bowel cleansing, Patient tolerability, Amitiza, Dulcolax, Miralax, Colonoscopy preparation, Bowel preparation, Screening colonoscopy