MoviPrep® Versus GoLYTELY® Bowel Preparation in Hospitalized Patients Undergoing Colonoscopy

Study Overview
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Brief Summary
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Adequate bowel cleansing is a critical component in the care of hospitalized patients undergoing colonoscopy. However, inpatient status is a well-established risk factor for inadequate bowel preparation. However, few strategies have been rigorously shown to reduce the risk of inadequate bowel preparation. Moreover, inadequate bowel preparation is frequently related to the poor tolerability of high volumes of bowel preparation in the medically complex and comorbid hospitalized population. Low volume bowel preparations have been developed that have been shown to be noninferior compared to high volume bowel preparation with regards to adequacy of bowel preparation but with improved tolerability. However, the use of low volume bowel preparations for colonoscopies have largely been evaluated in the outpatient setting. In this study, we plan to compare rates of adequate bowel preparation and tolerability of a low volume bowel preparation, MoviPrep, compared to standard high volume bowel preparation, GoLYTELY, in hospitalized patients undergoing colonoscopy. This study promises to highlight low volume bowel preparation as a viable and better tolerated alternative to high volume bowel preparation in hospitalized patients which may ultimately decrease delays in inpatient endoscopy as well as hospital length of stay.

Official Title
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Efficacy, Safety, and Tolerability of MoviPrep® Versus GoLYTELY® Bowel Preparation in Hospitalized Patients Undergoing Colonoscopy: a Randomized Control Trial

Conditions
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Bowel Preparation Before Colonoscopy

Intervention / Treatment
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* Drug: MoviPrep
* Drug: Golytely


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study Male or female, aged 18 or greater Hospitalized patient scheduled to undergo colonoscopy with bowel preparation (not including preparation with enemas alone) Ability to take bowel preparation and be willing to adhere to the regimen Exclusion Criteria: Patients presenting to the hospital with ileus, toxic megacolon, evidence of gastrointestinal obstruction Receipt of bowel preparation for other reasons during their hospitalization prior to their colonoscopy Patients with prior significant gastrointestinal surgeries including colonic resection, subtotal colectomy, abdomino-perineal resection, Hartmann's procedure or other similar surgeries involving structure/function of small intestine or colon Unable to give informed consent to the procedure Known glucose-6-phosphate dehydrogenase deficiency Known phenylketonuria Known hypersensitivity to polyethylene glycols or ascorbic acid Patients undergoing colonoscopy for foreign body removal and/or decompression Pregnancy or lactating women

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MoviPrep<br>For MoviPrep, the dose, schedule, and route of administration are as follows: On the evening prior to the colonoscopy, mix the powder with lukewarm water to a total volume of 32 oz. Drink 8 oz. every 15 minutes until the solution is finished. Drink 16 oz. of clear liquids before bed. On the morning of the procedure, repeat the above steps and make sure all fluids are consumed at least 2 hours prior to colonoscopy. Limit food intake to a regular breakfast, light lunch and clear soup or plain yogurt for dinner on the day prior to the colonoscopy (completed at least 1 hour prior to the first MoviPrep dose. Consume only clear liquids from the start of MoviPrep until after the colonoscopy. | Drug: MoviPrep<br>* Split-dose MoviPrep bowel preparation<br>|
| Active Comparator: GoLYTELY<br>For GoLYTELY, the dose, schedule, and route of administrate are as follows: On the evening prior to the colonoscopy, mix powder with lukewarm water to a total volume of 4 liters. Drink 2 liters of the solution and store the rest in the refrigerator. Drink the remaining 2 liters on the morning of the procedure. Limit food intake to a light breakfast on the day prior to the colonoscopy, followed by only clear liquids until the procedure is complete. Avoid red and purple liquids. | Drug: Golytely<br>* Split-dose GoLYTELY bowel preparation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Boston Bowel Preparation Score (BBPS) During Colonoscopy Withdrawal | The BBPS is a validated scoring tool that assesses the three segments of the colon (left, transverse, right) and rates them from 1-3 based on the ability to visualize the mucosa. An adequate bowel preparation is defined as a BBPS of 6 or higher with no individual segment scoring less than a 2. | At time of procedure, approximately 45 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mayo Clinic Bowel Preparation Questionnaire | The Mayo Clinic Bowel Preparation Questionnaire is a survey consisting of 9 questions that relate to symptoms and tolerability of bowel preparation before colonoscopy. The answers to each question will be aggregated for each arm and compared. | Immediately prior to procedure | 
| BBPS Score During Colonoscopy Withdrawal For Each Segment | BBPS assesses three segments of the colon (left, transverse, right) and rates each segment either a 1, 2, or 3 based on the ability to visualize the mucosa. Higher scores correspond to improved mucosal visibility. | At time of procedure, approximately 45 minutes | 
| Rates of Excellent Bowel Preparation | The BBPS is a validated scoring tool that assesses the three segments of the colon (left, transverse, right) and rates them from 1-3 based on the ability to visualize the mucosa. An excellent bowel preparation is defined as a BBPS score of an 8 or 9. | At time of procedure, approximately 45 minutes | 
| Cecal Intubation Rate | Percentage of colonoscopies during which the cecum is successfully reached | At time of procedure, approximately 45 minutes | 
| Cecal Intubation Time | Time from insertion of colonoscopy to reaching the cecum | At time of procedure, approximately 45 minutes | 
| Colonoscopy Withdrawal Time | Time from reaching the cecum to complete withdrawal of the colonoscope | At time of procedure, approximately 45 minutes | 
| Time to Endoscopy | The time from when the patient started the bowel preparation to the colonoscopy procedure itself. | At time of procedure, approximately 45 minutes | 
| Hospital Length of Stay | Time from admission to discharge | After study completion, an average of 5 days | 
| Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0 | The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term from a scale of 1-5, with increasing score corresponding to increasing AE severity. | Through study completion, an average of 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colonoscopy, bowel preparation, inpatient, tolerability