Safety and Efficacy of High Dose Bowel Preparation Solutions for Patients With Difficult To Clean Colons For Colonoscopy

The purpose of this study is to document the safety and effectiveness of high doses of liquids to clean the colon for colonoscopy in patients who had a previous colonoscopy with a poorly cleaned colon.

Study Overview

• Status: Completed
• Conditions: Preparation for Colonoscopy
• Intervention / Treatment: Drug: Bowel Preparation

Detailed Description

Most of our patients use a standard dose of Gatorade (64 oz) and a tasteless laxative powder called MiraLAX (306 g) to clean their colons out for a colonoscopy. Occasionally, patients have chosen to use other FDA approved solutions to clean their colons including NuLYTELY, GoLytely, MoviPrep and SuPREP. Rarely patients choose to use high doses of MagCitrate.

Despite drinking all their liquid to clean their colon, a few patients have difficult to clean out colons and the quality of their colonoscopy preparation was not good. No one has ever studied what liquids to give these patients when they have another colonoscopy. Most doctors recommend using higher than standard doses of bowel cleaning liquids, but the safety and effectiveness of these higher doses has never been studied.

Patients will already have been assigned a higher than standard dose of a bowel cleaning liquid of their choice for their planned colonoscopy. This is our standard of care for cleaning out the colons of patients who previous had colonoscopies with colons that were not adequately cleaned. If the patient chooses to participate in this study, the plans to clean their colon will remain unchanged.

Before and during the study: The subject will clean out thier colon in the days before their colonoscopy just as they would have if they were not part of the study. They will be asked to fill out a short questionnaire before the colonoscopy about their experience with the liquid and the clean out process.

We would like to obtain a blood test (basic metabolic profile) that looks at each subject's kidney function within 3 months before their colonoscopy and before the IV is started for the colonoscopy. This involves a simple needle stick to draw 1 teaspoon (5 ml) of blood. If the subject had had blood tests done for other reasons within 3 months of their colonoscopy, these results can be used in place of the first blood sample.

The only research activity is the collection of patient's blood and the questionnaire the subject will fill out before the colonoscopy. The preparation to clean their colon and the actually colonoscopy will be unaffected by this research.

• Study Type: Observational
• Enrollment (Actual): 79

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Downers Grove, Illinois, United States, 60515
      • Gastroenterology Services

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Patients in our practice who are undergoing a routine colonoscopy who had an inadequate preparation for colonoscopy in the past

Description

Inclusion Criteria:

• Patients at least 18 years old planning to undergo an elective colonoscopy will be eligible for inclusion in our study if they had a previous colonoscopy with an inadequate preparation.

Exclusion Criteria:

• Patients who are pregnant.
• Patients with ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or toxic megacolon would not be considered elective colonoscopies and are excluded.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Step 1; Patients who had inadequate preparations for colonoscopy with a standard dose of bowel cleansing agent.	Drug: Bowel Preparation; Standard 1/2 Dose: 153 g MiraLAX + 32 oz Gatorade 2 liters, 2 liters NuLYTELY, 1 liter MoviPrep, 16 oz (1 bottle) SuPREP, 10 oz (1 bottle) MagCitrate. Standard Full Dose: 306 g MiraLAX + 64 oz Gatorade, 4 liters NuLYTELY, 2 liters MoviPrep, 32 oz (2 bottles) SuPREP, 20 oz (2 bottles) MagCitrate. Step 1: 51 g MiraLAX* noon the day-prior; Full dose - 51 g MiraLAX 6 PM day-prior; 1/2 dose 4 hours before the colonoscopy. Step 2: 1/2 dose noon the day-prior; Full dose 6 PM the day-prior; 1/2 dose 4 hours before the colonoscopy. Step 3: Full dose noon the day-prior; Full dose 6 PM the day-prior; 1/2 dose 4 hours before the colonoscopy. Step 4: 1/2 dose 6 PM 2 days-prior; Full dose noon the day-prior; Full dose 6 PM the day-prior; 1/2 dose 4 hours before the colonoscopy. Step 5: Full dose 6 PM 2 days-prior; Full dose noon the day-prior; Full dose 6 PM the day-prior; 1/2 dose 4 hours before the colonoscopy.
Step 2; Patients who had inadequate preparations for colonoscopy with a step 1 dose of bowel cleansing agent.	Drug: Bowel Preparation; Standard 1/2 Dose: 153 g MiraLAX + 32 oz Gatorade 2 liters, 2 liters NuLYTELY, 1 liter MoviPrep, 16 oz (1 bottle) SuPREP, 10 oz (1 bottle) MagCitrate. Standard Full Dose: 306 g MiraLAX + 64 oz Gatorade, 4 liters NuLYTELY, 2 liters MoviPrep, 32 oz (2 bottles) SuPREP, 20 oz (2 bottles) MagCitrate. Step 1: 51 g MiraLAX* noon the day-prior; Full dose - 51 g MiraLAX 6 PM day-prior; 1/2 dose 4 hours before the colonoscopy. Step 2: 1/2 dose noon the day-prior; Full dose 6 PM the day-prior; 1/2 dose 4 hours before the colonoscopy. Step 3: Full dose noon the day-prior; Full dose 6 PM the day-prior; 1/2 dose 4 hours before the colonoscopy. Step 4: 1/2 dose 6 PM 2 days-prior; Full dose noon the day-prior; Full dose 6 PM the day-prior; 1/2 dose 4 hours before the colonoscopy. Step 5: Full dose 6 PM 2 days-prior; Full dose noon the day-prior; Full dose 6 PM the day-prior; 1/2 dose 4 hours before the colonoscopy.
Step 3; Patients who had inadequate preparations for colonoscopy with a step 2 dose of bowel cleansing agent.	Drug: Bowel Preparation; Standard 1/2 Dose: 153 g MiraLAX + 32 oz Gatorade 2 liters, 2 liters NuLYTELY, 1 liter MoviPrep, 16 oz (1 bottle) SuPREP, 10 oz (1 bottle) MagCitrate. Standard Full Dose: 306 g MiraLAX + 64 oz Gatorade, 4 liters NuLYTELY, 2 liters MoviPrep, 32 oz (2 bottles) SuPREP, 20 oz (2 bottles) MagCitrate. Step 1: 51 g MiraLAX* noon the day-prior; Full dose - 51 g MiraLAX 6 PM day-prior; 1/2 dose 4 hours before the colonoscopy. Step 2: 1/2 dose noon the day-prior; Full dose 6 PM the day-prior; 1/2 dose 4 hours before the colonoscopy. Step 3: Full dose noon the day-prior; Full dose 6 PM the day-prior; 1/2 dose 4 hours before the colonoscopy. Step 4: 1/2 dose 6 PM 2 days-prior; Full dose noon the day-prior; Full dose 6 PM the day-prior; 1/2 dose 4 hours before the colonoscopy. Step 5: Full dose 6 PM 2 days-prior; Full dose noon the day-prior; Full dose 6 PM the day-prior; 1/2 dose 4 hours before the colonoscopy.
Step 4; Patients who had inadequate preparations for colonoscopy with a step 3 dose of bowel cleansing agent.	Drug: Bowel Preparation; Standard 1/2 Dose: 153 g MiraLAX + 32 oz Gatorade 2 liters, 2 liters NuLYTELY, 1 liter MoviPrep, 16 oz (1 bottle) SuPREP, 10 oz (1 bottle) MagCitrate. Standard Full Dose: 306 g MiraLAX + 64 oz Gatorade, 4 liters NuLYTELY, 2 liters MoviPrep, 32 oz (2 bottles) SuPREP, 20 oz (2 bottles) MagCitrate. Step 1: 51 g MiraLAX* noon the day-prior; Full dose - 51 g MiraLAX 6 PM day-prior; 1/2 dose 4 hours before the colonoscopy. Step 2: 1/2 dose noon the day-prior; Full dose 6 PM the day-prior; 1/2 dose 4 hours before the colonoscopy. Step 3: Full dose noon the day-prior; Full dose 6 PM the day-prior; 1/2 dose 4 hours before the colonoscopy. Step 4: 1/2 dose 6 PM 2 days-prior; Full dose noon the day-prior; Full dose 6 PM the day-prior; 1/2 dose 4 hours before the colonoscopy. Step 5: Full dose 6 PM 2 days-prior; Full dose noon the day-prior; Full dose 6 PM the day-prior; 1/2 dose 4 hours before the colonoscopy.
Step 5; Patients who had inadequate preparations for colonoscopy with a step 4 dose of bowel cleansing agent.	Drug: Bowel Preparation; Standard 1/2 Dose: 153 g MiraLAX + 32 oz Gatorade 2 liters, 2 liters NuLYTELY, 1 liter MoviPrep, 16 oz (1 bottle) SuPREP, 10 oz (1 bottle) MagCitrate. Standard Full Dose: 306 g MiraLAX + 64 oz Gatorade, 4 liters NuLYTELY, 2 liters MoviPrep, 32 oz (2 bottles) SuPREP, 20 oz (2 bottles) MagCitrate. Step 1: 51 g MiraLAX* noon the day-prior; Full dose - 51 g MiraLAX 6 PM day-prior; 1/2 dose 4 hours before the colonoscopy. Step 2: 1/2 dose noon the day-prior; Full dose 6 PM the day-prior; 1/2 dose 4 hours before the colonoscopy. Step 3: Full dose noon the day-prior; Full dose 6 PM the day-prior; 1/2 dose 4 hours before the colonoscopy. Step 4: 1/2 dose 6 PM 2 days-prior; Full dose noon the day-prior; Full dose 6 PM the day-prior; 1/2 dose 4 hours before the colonoscopy. Step 5: Full dose 6 PM 2 days-prior; Full dose noon the day-prior; Full dose 6 PM the day-prior; 1/2 dose 4 hours before the colonoscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bowel Cleanliness	Measured by the Chicago Bowel Preparation Scale	at colonoscopy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bowel Cleanliness	Measured by the Boston Bowel Preparation Scale	at colonoscopy
Bowel Cleanliness	Measured by an adequate/inadequate bowel preparation scale	at colonoscopy
Patient tolerance	subject questionnaire	1-2 days before colonoscopy measured at colonoscopy
Electrolyte changes	measured using a BMP before and after the colonoscopy preparation	at colonoscopy

Collaborators and Investigators

• Sponsor: Gastroenterology Services, Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): January 1, 2021
• Study Completion (Actual): January 1, 2021

Study Registration Dates

• First Submitted: January 19, 2016
• First Submitted That Met QC Criteria: January 21, 2016
• First Posted (Estimate): January 22, 2016

Study Record Updates

• Last Update Posted (Actual): July 27, 2021
• Last Update Submitted That Met QC Criteria: July 26, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Cleansing the colon
• Other Study ID Numbers: 2015-0004-02

Plan for Individual participant data (IPD)

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