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Completed

NCT Number: NCT05054036

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

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.

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Key information

Conditions

Bowel Preparation Before Colonoscopy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bridgeport Hospital, Bridgeport, Connecticut, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Male or female, aged 18 or greater
  • Hospitalized patient scheduled to undergo colonoscopy with bowel preparation (not including preparation with enemas alone)
  • Ability to take bowel preparation and be willing to adhere to the regimen

Exclusion criteria

  • Patients presenting to the hospital with ileus, toxic megacolon, evidence of gastrointestinal obstruction
  • Receipt of bowel preparation for other reasons during their hospitalization prior to their colonoscopy
  • 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
  • Unable to give informed consent to the procedure
  • Known glucose-6-phosphate dehydrogenase deficiency
  • Known phenylketonuria
  • Known hypersensitivity to polyethylene glycols or ascorbic acid
  • Patients undergoing colonoscopy for foreign body removal and/or decompression
  • Pregnancy or lactating women

Treatment and study plan

MoviPrep

Drug

Split-dose MoviPrep bowel preparation

Golytely

Drug

Split-dose GoLYTELY bowel preparation

Primary outcomes

  1. Number of Participants With Adequate Bowel Preparation

    Time frame: At time of procedure, approximately 45 minutes

    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.

Secondary outcomes

  1. Mean Boston-Bowel-Preparation-Scale (BBPS) Score During Colonoscopy Withdrawal For Each Segment

    Time frame: At time of procedure, approximately 45 minutes

    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.

  2. Number of Participants With "Excellent" Bowel Preparation

    Time frame: At time of procedure, approximately 45 minutes

    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.

  3. Cecal Intubation

    Time frame: At time of procedure, approximately 45 minutes

    Number of participants with colonoscopies during which the cecum is successfully reached

  4. Cecal Intubation Time

    Time frame: At time of procedure, approximately 45 minutes

    Time from insertion of colonoscopy to reaching the cecum

  5. Colonoscopy Withdrawal Time

    Time frame: At time of procedure, approximately 45 minutes

    Time from reaching the cecum to complete withdrawal of the colonoscope

  6. Time to Colonoscopy

    Time frame: From start of prep to time of procedure, up to 21 hours

    The time from when the patient started the bowel preparation to the colonoscopy procedure itself.

  7. Hospital Length of Stay

    Time frame: After study completion, an average of 10 days

    Time from admission to discharge

  8. Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0

    Time frame: Through study completion, an average of 3 days

    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.

  9. Mayo Clinic Bowel Preparation Questionnaire- Tolerability Question 1

    Time frame: Immediately prior to procedure

    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?"

  10. Mayo Clinic Bowel Preparation Questionnaire- Tolerability Question 2

    Time frame: Immediately prior to procedure

    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?"

  11. Mayo Clinic Bowel Preparation Questionnaire- Tolerability Question 3

    Time frame: Immediately prior to procedure

    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?"

  12. Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 1

    Time frame: Immediately prior to procedure

    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"

  13. Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 2

    Time frame: Immediately prior to procedure

    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"

  14. Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 3

    Time frame: Immediately prior to procedure

    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"

  15. Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 4

    Time frame: Immediately prior to procedure

    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"

  16. Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 5

    Time frame: Immediately prior to procedure

    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"

  17. Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 6

    Time frame: Immediately prior to procedure

    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"

  18. Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 7

    Time frame: Immediately prior to procedure

    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"

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 23, 2021
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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