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

Phase 4

Completed

• Conditions: Bowel Preparation Before Colonoscopy
• Interventions: Drug: MoviPrep; Drug: Golytely

• Registration Number: NCT05054036
• Lead Sponsor: Yale University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-09
• Study First Submitted QC: 2021-09-22
• Study First Posted: 2021-09-23
• Study Start: 2022-01-12
• Primary Completion: 2024-07-01
• Study Completion: 2024-07-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-06
• Last Update Posted: 2024-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 520

Inclusion Criteria

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged 18 or greater
4. Hospitalized patient scheduled to undergo colonoscopy with bowel preparation (not including preparation with enemas alone)
5. Ability to take bowel preparation and be willing to adhere to the regimen

Read More

Exclusion Criteria

1. Patients presenting to the hospital with ileus, toxic megacolon, evidence of gastrointestinal obstruction
2. Receipt of bowel preparation for other reasons during their hospitalization prior to their colonoscopy
3. 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
4. Unable to give informed consent to the procedure
5. Known glucose-6-phosphate dehydrogenase deficiency
6. Known phenylketonuria
7. Known hypersensitivity to polyethylene glycols or ascorbic acid
8. Patients undergoing colonoscopy for foreign body removal and/or decompression
9. Pregnancy or lactating women

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MoviPrep	MoviPrep	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.
GoLYTELY	Golytely	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.

Primary Outcome Measures

Name	Time	Method
Boston Bowel Preparation Score (BBPS) During Colonoscopy Withdrawal	At time of procedure, approximately 45 minutes	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.

Secondary Outcome Measures

Name	Time	Method
Cecal Intubation Rate	At time of procedure, approximately 45 minutes	Percentage of colonoscopies during which the cecum is successfully reached
Cecal Intubation Time	At time of procedure, approximately 45 minutes	Time from insertion of colonoscopy to reaching the cecum
Rates of "Excellent" Bowel Preparation	At time of procedure, approximately 45 minutes	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.
Colonoscopy Withdrawal Time	At time of procedure, approximately 45 minutes	Time from reaching the cecum to complete withdrawal of the colonoscope
Hospital Length of Stay	After study completion, an average of 5 days	Time from admission to discharge
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0	Through study completion, an average of 3 days	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.
Mayo Clinic Bowel Preparation Questionnaire	Immediately prior to procedure	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.
BBPS Score During Colonoscopy Withdrawal For Each Segment	At time of procedure, approximately 45 minutes	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.
Time to Endoscopy	At time of procedure, approximately 45 minutes	The time from when the patient started the bowel preparation to the colonoscopy procedure itself.

Trial Locations

Locations (2)

Bridgeport Hospital; 🇺🇸 Bridgeport, Connecticut, United States

Yale New-Haven Hospital; 🇺🇸 New Haven, Connecticut, United States