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

Yale University

Status and phase: Completed; Phase 4

Conditions: Bowel Preparation Before Colonoscopy

Treatments: Drug: MoviPrep; Drug: Golytely

Study type: Interventional

Funder types: Other

Identifiers

NCT05054036

2000031169

000

Details and patient eligibility

About

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.

Enrollment: 520 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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520 participants in 2 patient groups

MoviPrep

Experimental group

Description:

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.

Treatment:

Drug: MoviPrep

GoLYTELY

Active Comparator group

Description:

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.

Treatment:

Drug: Golytely