Bowel Preparation for Colonoscopy
Conditions
Keywords
Colonoscopy, Bowel Preparation, MiraLAX, Gatorade, PEG-3350, MoviPrep, SUPREP, Chicago Bowel Preparation Scale, Boston Bowel Preparation Scale
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.
Interventions
Sponsors
Gastroenterology Services, Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
1. Patients who are allergic (this is very rare) or intolerant to any of the study drugs. 2. Patients who are pregnant. 3. Patients who required multiple day colon preparations (2 days prior and 1 day prior) in the past will be excluded. 4. Patients with ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or toxic megacolon would not be considered elective colonoscopies and are excluded. 5. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MiraLAX 306 g (Day-Prior) 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: MiraLAX consumed as described in each arm.
Gatorade: Gatorade consumed as described in each arm. | 200 |
| MiraLAX 357 g (Day-Prior) 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: MiraLAX consumed as described in each arm.
Gatorade: Gatorade consumed as described in each arm. | 200 |
| MiraLAX 306 g (Split-Dose) 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.
MiraLAX: MiraLAX consumed as described in each arm.
Gatorade: Gatorade consumed as described in each arm. | 200 |
| MoviPrep (Split-Dose) 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.
MoviPrep: MoviPrep consumed as described in each arm. | 200 |
| SUPREP (Split-Dose) 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.
SUPREP: SUPREP consumed as described in each arm. | 200 |
| Total | 1,000 |
Baseline characteristics
| Characteristic | MiraLAX 306 g (Day-Prior) | MiraLAX 357 g (Day-Prior) | MiraLAX 306 g (Split-Dose) | MoviPrep (Split-Dose) | SUPREP (Split-Dose) | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 60.9 years STANDARD_DEVIATION 12.7 | 61.3 years STANDARD_DEVIATION 12.4 | 59.1 years STANDARD_DEVIATION 11.3 | 60.1 years STANDARD_DEVIATION 11.4 | 60.6 years STANDARD_DEVIATION 11.2 | 60.4 years STANDARD_DEVIATION 11.8 |
| Region of Enrollment United States | 200 participants | 200 participants | 200 participants | 200 participants | 200 participants | 1000 participants |
| Sex: Female, Male Female | 99 Participants | 99 Participants | 101 Participants | 97 Participants | 99 Participants | 495 Participants |
| Sex: Female, Male Male | 101 Participants | 101 Participants | 99 Participants | 103 Participants | 101 Participants | 505 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 200 | 0 / 200 | 0 / 200 | 0 / 200 | 0 / 200 |
| other Total, other adverse events | 119 / 200 | 122 / 200 | 126 / 200 | 110 / 200 | 111 / 200 |
| serious Total, serious adverse events | 0 / 200 | 0 / 200 | 0 / 200 | 0 / 200 | 0 / 200 |
Outcome results
Primary
Chicago Bowel Preparation Scale
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).
Time frame: At completion of colonoscopy - day 1
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MiraLAX 306 g (Day-Prior) | Chicago Bowel Preparation Scale | Chicago BPS Total Score | 33.54 units on a scale | Standard Deviation 4.28 |
| MiraLAX 306 g (Day-Prior) | Chicago Bowel Preparation Scale | Chicago BPS Fluid Score | 0.90 units on a scale | Standard Deviation 0.83 |
| MiraLAX 306 g (Day-Prior) | Chicago Bowel Preparation Scale | Modified Chicago BPS Total Score | 31.82 units on a scale | Standard Deviation 3.59 |
| MiraLAX 357 g (Day-Prior) | Chicago Bowel Preparation Scale | Modified Chicago BPS Total Score | 32.14 units on a scale | Standard Deviation 3.69 |
| MiraLAX 357 g (Day-Prior) | Chicago Bowel Preparation Scale | Chicago BPS Total Score | 34.00 units on a scale | Standard Deviation 4.25 |
| MiraLAX 357 g (Day-Prior) | Chicago Bowel Preparation Scale | Chicago BPS Fluid Score | 1.03 units on a scale | Standard Deviation 0.89 |
| MiraLAX 306 g (Split-Dose) | Chicago Bowel Preparation Scale | Modified Chicago BPS Total Score | 32.33 units on a scale | Standard Deviation 2.93 |
| MiraLAX 306 g (Split-Dose) | Chicago Bowel Preparation Scale | Chicago BPS Total Score | 34.67 units on a scale | Standard Deviation 3.58 |
| MiraLAX 306 g (Split-Dose) | Chicago Bowel Preparation Scale | Chicago BPS Fluid Score | 1.84 units on a scale | Standard Deviation 0.9 |
| MoviPrep (Split-Dose) | Chicago Bowel Preparation Scale | Chicago BPS Total Score | 34.95 units on a scale | Standard Deviation 3.39 |
| MoviPrep (Split-Dose) | Chicago Bowel Preparation Scale | Chicago BPS Fluid Score | 1.45 units on a scale | Standard Deviation 0.82 |
| MoviPrep (Split-Dose) | Chicago Bowel Preparation Scale | Modified Chicago BPS Total Score | 32.54 units on a scale | Standard Deviation 2.92 |
| SUPREP (Split-Dose) | Chicago Bowel Preparation Scale | Modified Chicago BPS Total Score | 32.65 units on a scale | Standard Deviation 1.72 |
| SUPREP (Split-Dose) | Chicago Bowel Preparation Scale | Chicago BPS Total Score | 35.16 units on a scale | Standard Deviation 2.34 |
| SUPREP (Split-Dose) | Chicago Bowel Preparation Scale | Chicago BPS Fluid Score | 1.30 units on a scale | Standard Deviation 0.91 |
Comparison: All 5 arms were compared pair-wise.~1=G+PEG-306 2=G+PEG-357 3=G+PEG-Split 4=PEG+Asc-Split 5=SS-Splitp-value: <0.005t-test, 2 sided
Secondary
Adequate/Inadequate Scale
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.
Time frame: At completion of colonoscopy - day 1
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MiraLAX 306 g (Day-Prior) | Adequate/Inadequate Scale | Adequate | 195 Participants |
| MiraLAX 306 g (Day-Prior) | Adequate/Inadequate Scale | Inadequate | 5 Participants |
| MiraLAX 357 g (Day-Prior) | Adequate/Inadequate Scale | Inadequate | 4 Participants |
| MiraLAX 357 g (Day-Prior) | Adequate/Inadequate Scale | Adequate | 196 Participants |
| MiraLAX 306 g (Split-Dose) | Adequate/Inadequate Scale | Inadequate | 2 Participants |
| MiraLAX 306 g (Split-Dose) | Adequate/Inadequate Scale | Adequate | 198 Participants |
| MoviPrep (Split-Dose) | Adequate/Inadequate Scale | Adequate | 197 Participants |
| MoviPrep (Split-Dose) | Adequate/Inadequate Scale | Inadequate | 3 Participants |
| SUPREP (Split-Dose) | Adequate/Inadequate Scale | Inadequate | 3 Participants |
| SUPREP (Split-Dose) | Adequate/Inadequate Scale | Adequate | 197 Participants |
Comparison: All 5 arms were compared pair-wise.p-value: >0.005Chi-squared
Secondary
Boston Bowel Preparation Scale
The quality of the colon preparation as graded using Boston Bowel Preparation total scores is range from 0 (very poor) to 9 (outstanding).
Time frame: At completion of colonoscopy - day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MiraLAX 306 g (Day-Prior) | Boston Bowel Preparation Scale | 8.39 units on a scale | Standard Deviation 1.36 |
| MiraLAX 357 g (Day-Prior) | Boston Bowel Preparation Scale | 8.57 units on a scale | Standard Deviation 1.16 |
| MiraLAX 306 g (Split-Dose) | Boston Bowel Preparation Scale | 8.66 units on a scale | Standard Deviation 1.16 |
| MoviPrep (Split-Dose) | Boston Bowel Preparation Scale | 8.80 units on a scale | Standard Deviation 1.04 |
| SUPREP (Split-Dose) | Boston Bowel Preparation Scale | 8.80 units on a scale | Standard Deviation 0.77 |
Comparison: All 5 arms were compared pair-wise.~1=G+PEG-306 2=G+PEG-357 3=G+PEG-Split 4=PEG+Asc-Split 5=SS-Splitp-value: <0.001t-test, 2 sided