Preparation for Colonoscopy
Conditions
Brief summary
The purpose of this study is to compare Nulytely (or Trilyte) with a Gatorade and Miralax combination for cleaning out the colon before colonoscopy. A laxative pill called Bisacodyl may also be used with the Gatorade and Miralax to see if it helps with the clean out process. We are trying to find out if either of these methods is more acceptable to the patient and does a better job cleaning out the colon for a colonoscopy.
Interventions
DRUGGatorade/Miralax
Gatorade 64 oz (1/2 gallon), Miralax 306 g to be consumed the day before your colonoscopy as follows: Miralax 51 g at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.
DRUGNuLytely
Nulytely (or Trilyte) 128 oz (1 gallon) to be consumed from about 5 PM to 9 PM the night before the colonoscopy.
DRUGBisacodyl
Bisacodyl 10 mg (two 5 mg pills) to be consumed the day before the colonoscopy at 12 noon.
DRUGPlacebo
Placebo (two 0.4 mg folic acid pills) to be consumed the day before the colonoscopy
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
1\. Patients at least 18 years old planning to undergo an elective colonoscopy.
Exclusion criteria
1. Patients who are allergic or intolerant to any on the study drugs. 2. Pregnant patients. 3. Patients who required multiple day colon preparation in the past. 4. Patients with ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or toxic megacolon would not be considered elective colonoscopies and are excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Quality of the Colon Preparation Will be Graded Using the Boston Bowel Preparation Scale | After Colonoscopy | The Boston Bowel Preparation Scale measures cleanliness of the colon on a scale of 0 (very poor) to 9 (excellent). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Ottawa Scale for Colonoscopy Preparation Will be Reported and Compared Among the 3 Groups to Allow for Comparisons to Some of the Older Literature | After Colonoscopy | Ottawa scale measures colon cleanliness on a scale from 14 (very poor) to 0 (excellent). |
Countries
United States
Participant flow
Recruitment details
Subjects had their colonoscopy performed between February 2010 and February 2011 by one of three gastroenterologists (DG, JH, and MR) with 17 to 34 years of experience. Colonoscopies were scheduled to begin between 0800 h and noon in the gastrointestinal labs at our office or two community hospitals.
Participants by arm
| Arm | Count |
|---|---|
| Nulytely Nulytely (or Trilyte) 128 oz (1 gallon) to be consumed from about 5 PM to 9 PM the night before the colonoscopy. | 200 |
| Gatorade/Miralax + Placebo Gatorade 64 oz (1/2 gallon), Miralax 306 g and a placebo (two 0.4 mg folic acid pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and placebo at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM. | 200 |
| Gatorade/Miralax + Bisacodyl Gatorade 64 oz (1/2 gallon), Miralax 306 g and Bisacodyl 10 mg (two 5 mg pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and Bisacodyl 10 mg at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM. | 200 |
| Total | 600 |
Baseline characteristics
| Characteristic | Gatorade/Miralax + Placebo | Gatorade/Miralax + Bisacodyl | Nulytely | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 80 Participants | 80 Participants | 80 Participants | 240 Participants |
| Age, Categorical Between 18 and 65 years | 120 Participants | 120 Participants | 120 Participants | 360 Participants |
| Age Continuous | 59.7 years STANDARD_DEVIATION 13.8 | 61.3 years STANDARD_DEVIATION 12.5 | 60.2 years STANDARD_DEVIATION 13.2 | 60.4 years STANDARD_DEVIATION 13.2 |
| Region of Enrollment United States | 200 participants | 200 participants | 200 participants | 600 participants |
| Sex: Female, Male Female | 91 Participants | 99 Participants | 81 Participants | 271 Participants |
| Sex: Female, Male Male | 109 Participants | 101 Participants | 119 Participants | 329 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 200 | 0 / 200 | 0 / 200 |
| serious Total, serious adverse events | 0 / 200 | 1 / 200 | 0 / 200 |
Outcome results
Primary
The Quality of the Colon Preparation Will be Graded Using the Boston Bowel Preparation Scale
The Boston Bowel Preparation Scale measures cleanliness of the colon on a scale of 0 (very poor) to 9 (excellent).
Time frame: After Colonoscopy
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nulytely | The Quality of the Colon Preparation Will be Graded Using the Boston Bowel Preparation Scale | 7.86 units on a scale | Standard Deviation 1.55 |
| Gatorade/Miralax + Placebo | The Quality of the Colon Preparation Will be Graded Using the Boston Bowel Preparation Scale | 8.05 units on a scale | Standard Deviation 1.28 |
| Gatorade/Miralax + Bisacodyl | The Quality of the Colon Preparation Will be Graded Using the Boston Bowel Preparation Scale | 7.99 units on a scale | Standard Deviation 1.41 |
Secondary
The Ottawa Scale for Colonoscopy Preparation Will be Reported and Compared Among the 3 Groups to Allow for Comparisons to Some of the Older Literature
Ottawa scale measures colon cleanliness on a scale from 14 (very poor) to 0 (excellent).
Time frame: After Colonoscopy
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nulytely | The Ottawa Scale for Colonoscopy Preparation Will be Reported and Compared Among the 3 Groups to Allow for Comparisons to Some of the Older Literature | 2.80 units on a scale | Standard Deviation 2.24 |
| Gatorade/Miralax + Placebo | The Ottawa Scale for Colonoscopy Preparation Will be Reported and Compared Among the 3 Groups to Allow for Comparisons to Some of the Older Literature | 2.58 units on a scale | Standard Deviation 2.47 |
| Gatorade/Miralax + Bisacodyl | The Ottawa Scale for Colonoscopy Preparation Will be Reported and Compared Among the 3 Groups to Allow for Comparisons to Some of the Older Literature | 2.71 units on a scale | Standard Deviation 2.47 |