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

Last updated: November 6, 2024
Sponsor: Yale University
Overall Status: Completed

Phase

4

Condition

N/A

Treatment

MoviPrep

Golytely

Clinical Study ID

NCT05054036
2000031169
000
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Provision of signed and dated informed consent form

  2. Stated willingness to comply with all study procedures and availability for theduration of the study

  3. Male or female, aged 18 or greater

  4. Hospitalized patient scheduled to undergo colonoscopy with bowel preparation (notincluding preparation with enemas alone)

  5. Ability to take bowel preparation and be willing to adhere to the regimen

Exclusion

Exclusion Criteria:

  1. Patients presenting to the hospital with ileus, toxic megacolon, evidence ofgastrointestinal obstruction

  2. Receipt of bowel preparation for other reasons during their hospitalization prior totheir colonoscopy

  3. Patients with prior significant gastrointestinal surgeries including colonicresection, subtotal colectomy, abdomino-perineal resection, Hartmann's procedure orother 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

Study Design

Total Participants: 520
Treatment Group(s): 2
Primary Treatment: MoviPrep
Phase: 4
Study Start date:
January 12, 2022
Estimated Completion Date:
July 01, 2024

Connect with a study center

  • Bridgeport Hospital

    Bridgeport, Connecticut 06610
    United States

    Site Not Available

  • Yale New-Haven Hospital

    New Haven, Connecticut 06510
    United States

    Site Not Available

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