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

Bowel Preparation Before Colonoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05054036
• Other study ID #: 2000031169
• Secondary ID: 000
• Status: Recruiting
• Phase: Phase 4
• Start date: January 12, 2022
• Est. completion date: August 1, 2024

Study information

• Verified date: June 2024
• Source: Yale University
• Contact: Darrick K Li, MD, PhD
• Phone: 203-285-4506
• Email: darrick.li[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: August 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bowel Preparation Before Colonoscopy

Intervention

Drug:
• MoviPrep
Split-dose MoviPrep bowel preparation
• Golytely
Split-dose GoLYTELY bowel preparation

Locations

Country	Name	City	State
United States	Bridgeport Hospital	Bridgeport	Connecticut
United States	Yale New-Haven Hospital	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Boston Bowel Preparation Score (BBPS) During Colonoscopy Withdrawal	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.	At time of procedure, approximately 45 minutes
Secondary	Mayo Clinic Bowel Preparation Questionnaire	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.	Immediately prior to procedure
Secondary	BBPS Score During Colonoscopy Withdrawal For Each Segment	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.	At time of procedure, approximately 45 minutes
Secondary	Rates of "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
Secondary	Cecal Intubation Rate	Percentage of colonoscopies during which the cecum is successfully reached	At time of procedure, approximately 45 minutes
Secondary	Cecal Intubation Time	Time from insertion of colonoscopy to reaching the cecum	At time of procedure, approximately 45 minutes
Secondary	Colonoscopy Withdrawal Time	Time from reaching the cecum to complete withdrawal of the colonoscope	At time of procedure, approximately 45 minutes
Secondary	Time to Endoscopy	The time from when the patient started the bowel preparation to the colonoscopy procedure itself.	At time of procedure, approximately 45 minutes
Secondary	Hospital Length of Stay	Time from admission to discharge	After study completion, an average of 5 days
Secondary	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