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

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

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.

Study Overview

• Status: Completed
• Conditions: Bowel Preparation Before Colonoscopy
• Intervention / Treatment: Drug: MoviPrep; Drug: Golytely

• Study Type: Interventional
• Enrollment (Actual): 520
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Bridgeport, Connecticut, United States, 06610
      • Bridgeport Hospital
    • New Haven, Connecticut, United States, 06510
      • Yale New-Haven Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: MoviPrep; Split-dose MoviPrep bowel preparation
Active Comparator: 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.	Drug: Golytely; Split-dose GoLYTELY bowel preparation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adequate Bowel Preparation	The Boston-Bowel-Preparation-Scale (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
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
Mean Boston-Bowel-Preparation-Scale (BBPS) Score During Colonoscopy Withdrawal For Each Segment	BBPS assesses three segments of the colon (left, transverse, right) and scores 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
Number of Participants With "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	Number of participants with colonoscopies during which the cecum is successfully reached	At time of procedure, approximately 45 minutes
Time to Colonoscopy	The time from when the patient started the bowel preparation to the colonoscopy procedure itself.	From start of prep to time of procedure, up to 21 hours
Hospital Length of Stay	Time from admission to discharge	After study completion, an average of 10 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
Mayo Clinic Bowel Preparation Questionnaire- Tolerability Question 1	The Mayo Clinic Bowel Preparation Questionnaire is a survey consisting of questions that relate to symptoms and tolerability of bowel preparation before colonoscopy. Data presented here is for "How much of the bowel preparation was left in the bottle after drinking it to your best effort?"	Immediately prior to procedure
Mayo Clinic Bowel Preparation Questionnaire- Tolerability Question 2	The Mayo Clinic Bowel Preparation Questionnaire is a survey consisting of questions that relate to symptoms and tolerability of bowel preparation before colonoscopy. Data presented here is for "How tolerable did you find the bowel prep?"	Immediately prior to procedure
Mayo Clinic Bowel Preparation Questionnaire- Tolerability Question 3	The Mayo Clinic Bowel Preparation Questionnaire is a survey consisting of questions that relate to symptoms and tolerability of bowel preparation before colonoscopy. Data presented here is for "Based on your current experience, would you be willing to drink the same prep again if you need another colonoscopy in the future?"	Immediately prior to procedure
Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 1	The Mayo Clinic Bowel Preparation Questionnaire is a survey consisting of questions that relate to symptoms and tolerability of bowel preparation before colonoscopy. Data presented here is for "Bad taste in mouth"	Immediately prior to procedure
Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 2	The Mayo Clinic Bowel Preparation Questionnaire is a survey consisting of questions that relate to symptoms and tolerability of bowel preparation before colonoscopy. Data presented here is for "Gastric fullness"	Immediately prior to procedure
Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 3	The Mayo Clinic Bowel Preparation Questionnaire is a survey consisting of questions that relate to symptoms and tolerability of bowel preparation before colonoscopy. Data presented here is for "Lack of sleep from excessive bathroom trips"	Immediately prior to procedure
Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 4	The Mayo Clinic Bowel Preparation Questionnaire is a survey consisting of questions that relate to symptoms and tolerability of bowel preparation before colonoscopy. Data presented here is for "Nausea/vomiting"	Immediately prior to procedure
Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 5	The Mayo Clinic Bowel Preparation Questionnaire is a survey consisting of questions that relate to symptoms and tolerability of bowel preparation before colonoscopy. Data presented here is for "Bloating/abdominal distension/gas"	Immediately prior to procedure
Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 6	The Mayo Clinic Bowel Preparation Questionnaire is a survey consisting of questions that relate to symptoms and tolerability of bowel preparation before colonoscopy. Data presented here is for "Abdominal pain/cramps"	Immediately prior to procedure
Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 7	The Mayo Clinic Bowel Preparation Questionnaire is a survey consisting of questions that relate to symptoms and tolerability of bowel preparation before colonoscopy. Data presented here is for "Headache"	Immediately prior to procedure

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Darrick K Li, MD, PhD, Yale University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• Xiao K, Khan F, Link R, Dominguez-Diaz A, Ameyaw P, Alexis J, Tai CH, Assalone V, Nasufi M, Hughes ML, Loeser C, Hung K, Li DK. Efficacy and Safety of Low Volume Bowel Preparation for Colonoscopy in Hospitalized Patients: A Randomized Noninferiority Trial. J Clin Gastroenterol. 2025 Oct 24. doi: 10.1097/MCG.0000000000002269. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2022
• Primary Completion (Actual): July 1, 2024
• Study Completion (Actual): July 1, 2024

Study Registration Dates

• First Submitted: September 9, 2021
• First Submitted That Met QC Criteria: September 22, 2021
• First Posted (Actual): September 23, 2021

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: February 17, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: tolerability; colonoscopy; bowel preparation; inpatient
• Additional Relevant MeSH Terms: MoviPrep; Golytely
• Other Study ID Numbers: 2000031169; 000 (Other Identifier: YCTG)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes