A Comparison of 5 Low Volume Bowel Preparations

Phase 4

Completed

Conditions: Bowel Preparation for Colonoscopy

Interventions: Drug: SUPREP
Drug: MiraLAX
Drug: MoviPrep
Other: Gatorade

Registration Number: NCT01719653

Lead Sponsor: Gastroenterology Services, Ltd.

Brief Summary: The purpose of this investigation is to compare 3 versions of MiraLAX/Gatorade, MoviPrep and SUPREP to see which preparation cleanses the colon best and which preparation is best tolerated.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1079

Inclusion Criteria

Patients at least 18 years old planning to undergo an elective colonoscopy will be eligible for inclusion in our study. We would prefer to exclude as few groups as possible since in clinical practice these less well studied groups often need a colonoscopy and will need to have a colonoscopy preparation.

Exclusion Criteria

Patients who are allergic (this is very rare) or intolerant to any of the study drugs.
Patients who are pregnant.
Patients who required multiple day colon preparations (2 days prior and 1 day prior) in the past will be excluded.
Patients with ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or toxic megacolon would not be considered elective colonoscopies and are excluded.
Patients with known renal disease (baseline creatinine greater than 1.50 mg/dl) will need to be excluded due to the magnesium in SUPREP which is contraindicated in patients with significant renal disease.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MiraLAX 306 g (Split-Dose)	Gatorade	MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed as a split-dose as follows: Gatorade 32oz mixed with Miralax 153 g from about 6 PM to 8 PM the day prior to the colonoscopy; Gatorade 32oz mixed with Miralax 153 g from about 2-4 hours prior to the colonoscopy.
SUPREP (Split-Dose)	SUPREP	SUPREP consumed as a split-dose as follows: SUPREP 16 oz consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 32 oz of clear liquids; SUPREP 16 oz consumed from 3-4 hours prior to the colonoscopy followed by 32 oz of clear liquids.
MiraLAX 357 g (Day-Prior)	Gatorade	MiraLAX 357 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 68 g at 12 noon; Gatorade 64 oz mixed with Miralax 289 g from about 6 PM to 9 PM.
MiraLAX 306 g (Day-Prior)	Gatorade	MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 51 g at 12 noon; Gatorade 64 oz mixed with Miralax 255 g from about 6 PM to 9 PM
MiraLAX 306 g (Day-Prior)	MiraLAX	MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 51 g at 12 noon; Gatorade 64 oz mixed with Miralax 255 g from about 6 PM to 9 PM
MiraLAX 357 g (Day-Prior)	MiraLAX	MiraLAX 357 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 68 g at 12 noon; Gatorade 64 oz mixed with Miralax 289 g from about 6 PM to 9 PM.
MiraLAX 306 g (Split-Dose)	MiraLAX	MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed as a split-dose as follows: Gatorade 32oz mixed with Miralax 153 g from about 6 PM to 8 PM the day prior to the colonoscopy; Gatorade 32oz mixed with Miralax 153 g from about 2-4 hours prior to the colonoscopy.
MoviPrep (Split-Dose)	MoviPrep	MoviPrep consumed as a split-dose as follows: MoviPrep 1 liter consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 0.5 liter of clear liquids; MoviPrep 1 liter consumed from 3-4 hours prior to the colonoscopy followed by 0.5 liter of clear liquids.

Primary Outcome Measures

Name	Time	Method
Chicago Bowel Preparation Scale	At completion of colonoscopy - day 1	The quality of the colon preparation as graded using our new Chicago Bowel Preparation Scale (BPS) (Adventist Midwest Region Institutional Review Board, AMH 2010-01-80; ClinicalTrials.gov NCT01063049). Chicago BPS total score is ranges from 0 (very poor) to 36 (outstanding). Modified Chicago BPS total score is ranges from 0 (very poor) to 33 (outstanding). Chicago BPS Fluid score is ranges from 0 (dry) to 3 (wet).

Secondary Outcome Measures

Name	Time	Method
Adequate/Inadequate Scale	At completion of colonoscopy - day 1	The cleanliness of the colon as rated by the gastroenterologist using an adequate/inadequate scale where an adequate preparation is defined as being able to see at least 95% of the mucosa of the colon after washing and suctioning; otherwise, the preparation is rated as inadequate.
Boston Bowel Preparation Scale	At completion of colonoscopy - day 1	The quality of the colon preparation as graded using Boston Bowel Preparation total scores is range from 0 (very poor) to 9 (outstanding).