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

Yale University520 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

520

Conditions

Bowel Preparation Before Colonoscopy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: At time of procedure, approximately 45 minutes

Secondary Outcomes

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.

Time frame: Immediately prior to procedure

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.

Time frame: At time of procedure, approximately 45 minutes

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.

Time frame: At time of procedure, approximately 45 minutes

Cecal Intubation Rate

Percentage of colonoscopies during which the cecum is successfully reached

Time frame: At time of procedure, approximately 45 minutes

Cecal Intubation Time

Time from insertion of colonoscopy to reaching the cecum

Time frame: At time of procedure, approximately 45 minutes

Colonoscopy Withdrawal Time

Time from reaching the cecum to complete withdrawal of the colonoscope

Time frame: At time of procedure, approximately 45 minutes

Time to Endoscopy

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

Time frame: At time of procedure, approximately 45 minutes

Hospital Length of Stay

Time from admission to discharge

Time frame: After study completion, an average of 5 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.

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

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

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes