Clinical trial NCT05054036: MoviPrep® Versus GoLYTELY® Bowel Preparation in Hospitalized Patients Undergoing Colonoscopy
Official title: Efficacy, Safety, and Tolerability of MoviPrep® Versus GoLYTELY® Bowel Preparation in Hospitalized Patients Undergoing Colonoscopy: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bowel Preparation Before Colonoscopy
Keywords: colonoscopy
bowel preparation
inpatient
tolerability
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2021-09-23
Enrollment: 520
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Boston Bowel Preparation Score (BBPS) During Colonoscopy Withdrawal
timeFrame: At time of procedure, approximately 45 minutes
Secondary outcomes:
measure: Mayo Clinic Bowel Preparation Questionnaire
timeFrame: Immediately prior to procedure
measure: BBPS Score During Colonoscopy Withdrawal For Each Segment
timeFrame: At time of procedure, approximately 45 minutes
measure: Rates of "Excellent" Bowel Preparation
timeFrame: At time of procedure, approximately 45 minutes
measure: Cecal Intubation Rate
timeFrame: At time of procedure, approximately 45 minutes
measure: Cecal Intubation Time
timeFrame: At time of procedure, approximately 45 minutes
measure: Colonoscopy Withdrawal Time
timeFrame: At time of procedure, approximately 45 minutes
measure: Time to Endoscopy
timeFrame: At time of procedure, approximately 45 minutes
measure: Hospital Length of Stay
timeFrame: After study completion, an average of 5 days
measure: Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0
timeFrame: Through study completion, an average of 3 days
Other outcomes:
Locations:
city: Bridgeport
country: United States
facility: Bridgeport Hospital
state: Connecticut
city: New Haven
country: United States
facility: Yale New-Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Darrick K Li, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yadlapati R, Johnston ER, Gregory DL, Ciolino JD, Cooper A, Keswani RN. Predictors of Inadequate Inpatient Colonoscopy Preparation and Its Association with Hospital Length of Stay and Costs. Dig Dis Sci. 2015 Nov;60(11):3482-90. doi: 10.1007/s10620-015-3761-2. Epub 2015 Jun 21.
citation: Fuccio L, Frazzoni L, Spada C, Mussetto A, Fabbri C, Manno M, Aragona G, Zagari RM, Rondonotti E, Manes G, Occhipinti P, Cadoni S, Bazzoli F, Hassan C, Radaelli F; QIPS study group. Factors That Affect Adequacy of Colon Cleansing for Colonoscopy in Hospitalized Patients. Clin Gastroenterol Hepatol. 2021 Feb;19(2):339-348.e7. doi: 10.1016/j.cgh.2020.02.055. Epub 2020 Mar 18.
citation: Spadaccini M, Frazzoni L, Vanella G, East J, Radaelli F, Spada C, Fuccio L, Benamouzig R, Bisschops R, Bretthauer M, Dekker E, Dinis-Ribeiro M, Ferlitsch M, Gralnek I, Jover R, Kaminski MF, Pellise M, Triantafyllou K, Van Hooft JE, Dumonceau JM, Marmo C, Alfieri S, Chandrasekar VT, Sharma P, Rex DK, Repici A, Hassan C. Efficacy and Tolerability of High- vs Low-Volume Split-Dose Bowel Cleansing Regimens for Colonoscopy: A Systematic Review and Meta-analysis. Clin Gastroenterol Hepatol. 2020 Jun;18(7):1454-1465.e14. doi: 10.1016/j.cgh.2019.10.044. Epub 2019 Nov 1.
citation: Garber A, Sarvepalli S, Burke CA, Bhatt A, Ibrahim M, McMichael J, Morris-Stiff G, Rizk MK, Vargo JJ, Rothberg MB. Modifiable Factors Associated with Quality of Bowel Preparation Among Hospitalized Patients Undergoing Colonoscopy. J Hosp Med. 2019 May;14(5):278-283. doi: 10.12788/jhm.3173.
citation: Patel M, Staggs E, Thomas CS, Lukens F, Wallace M, Almansa C. Development and validation of the Mayo Clinic Bowel Prep Tolerability Questionnaire. Dig Liver Dis. 2014 Sep;46(9):808-12. doi: 10.1016/j.dld.2014.05.020. Epub 2014 Jun 19.