Efficacy and Patient Satisfaction of Miralax and Gatorade Versus Movi Prep

Study Overview
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Brief Summary
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This study will be comparing patient satisfaction, efficacy comparing miralax with gatorade versus Movi Prep for outpatient colonoscopy.

Detailed Description
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Study is the purpose of evaluating patient satisfaction and at the same time efficacy of the bowel regimen in cleansing the colon

Official Title
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Phase 4 of Efficacy and Patient Satisfaction of Miralax and Gatorade Versus Movi Prep

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: comparing 2 drugs on their effect on the bowel preparation for colonoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: outpatient colonoscopy for screening for other Gi related problems Exclusion Criteria: Severe Congestive Heart Failure (CHF), Chronic Kidney Disease (CKD), less than age 18 or more than 80 years

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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Accepts Healthy Volunteers

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 |
| --- | --- |
| Experimental: miralax<br>miralax with dulcolax and gatorade efficacy evaluated by colonoscopy and patient satisfaction evaluated by patient questionnaire | Drug: comparing 2 drugs on their effect on the bowel preparation for colonoscopy<br>* the effects of the drug on the colon preparation for colonoscopy<br>|
| Experimental: moviprep split dose<br>Efficacy of split dose moviprep on cleansing colon for colonoscopy and patient satisfaction with the regimen | Drug: comparing 2 drugs on their effect on the bowel preparation for colonoscopy<br>* the effects of the drug on the colon preparation for colonoscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bowel Prep Efficacy - Boston Bowel Preparation Scale (BBPS) | To assess the bowel prep efficacy in cleansing the colon for colonoscopy - Scale used is the Boston Bowel Preparation Scale (BBPS), Integer Scale from 0-3, where 3 indicated the best outcome and 0 the worst. The BBPS was estimated during the procedure (Colonoscopy) by an endoscopist and a nurse and retrospectively by a second endoscopist postoperatively. Scores were averaged by for each subject by location (Right colon, Transverse colon, and Left colon) and then for each group/arm by location. | Outcome BBPS was measured during surgery for endoscopist #1 and nurse raters and post-operatively (at any time before the end of the study) by endoscopist #2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal Function Pre and Post Bowel Prep (mg/dL) | Changes in electrolytes pre and post bowel preparation administration. Pre bowel prep measures were taken at study randomization (up to one week before surgery) and post bowel prep measures were taken prior to the procedure (less than 5 hours before start of procedure on day of procedure). Change is electrolytes are presented as pre bowel prep value minus post bowel prep value but prior to procedure (Pre-Post). Units = Milligrams/deciLiter (mg/dL) | Pre bowel prep measures were taken at study randomization (up to one week before surgery) and post bowel prep measures were taken prior to the procedure (less than 5 hours before start of procedure on day of procedure). | 
| Renal Function Pre and Post Bowel Prep - Continued (mmol/L) | Changes in electrolytes pre and post bowel preparation administration. Pre bowel prep measures were taken at study randomization (up to one week before surgery) and post bowel prep measures were taken prior to the procedure (less than 5 hours before start of procedure on day of procedure). Change is electrolytes are presented as pre bowel prep value minus post bowel prep value, but prior to procedure (Pre-Post). Units=Millimoles per Liter (mmol/L) | Pre bowel prep measures were taken at study randomization (up to one week before surgery) and post bowel prep measures were taken prior to the procedure (less than 5 hours before start of procedure on day of procedure). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Miralax with gatorade and dulcolax, Movi pre, Patient satisfaction and efficacy