Colonoscopy
Conditions
Keywords
Efficacy of bowel cleansing, Patient tolerability, Amitiza, Dulcolax, Miralax, Colonoscopy preparation, Bowel preparation, Screening colonoscopy
Brief summary
Miralax (PEG 3350) has been shown to be a safe and uncomplicated bowel preparation prior to colonoscopy in pediatric populations. This study seeks to confirm the efficacy of this bowel cleansing regimen in adults and to determine the benefit of adding a pretreatment medication to this bowel preparation. The tolerability of Miralax will hopefully improve patient satisfaction with colonoscopy and decrease their reluctance to be screened because of the uncomfortable taste and side effects of bowel preparation regimens.
Interventions
DRUGMiralax (PEG 3350)
Miralax 255gm bottle
DRUGAmitiza (Lubiprostone)
Amitiza 24mcg gelcap
DRUGDulcolax (Bisacodyl)
Bisacodyl 5mg tab x2
Golytely 1 gallon
Sponsors
Brooke Army Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* adult patients referred to our clinic for average or increased risk screening for colorectal cancer
Exclusion criteria
* elevated serum creatinine (Men \>1.4mg/dL, Women \>1.3mg/dL) * previous diagnosis of congestive heart failure * history of bowel obstruction * history of solid organ transplant * current pregnancy * lactating mother * participants allergic to either polyethylene glycol (Miralax), lubiprostone (Amitiza), or bisacodyl (Dulcolax)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Cleanliness of the Prep as Measured by the Ottawa Scale | measured at the time of colonoscopy | Bowel cleansing was evaluated with the Ottawa bowel preparation scale by each endoscopist during the endoscopy. Neither the endoscopist nor the endoscopy nurse was aware of the bowel preparation used prior to the colonoscopy. The Ottawa bowel preparation scale is a validated tool and was used in this study to provide a reliable quality assessment of the bowel preparation used for colonoscopy. This validated scale rates each section of the colon, the right, the mid, and the rectosigmoid colon, on a 5-point scale (0-4), as well as a global 3-point rating for overall colonic fluid (0-2). The total score ranges from 0 to 14. An excellent preparation with little fluid would score 0-3, a good preparation 4-6, while scores higher than 7 would indicate progressively worsening bowel preparations. A completely unprepared colon would score 11-14, depending on the amount of colonic fluid. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedure Time | measured at the time of colonoscopy | total colonoscopy procedure time |
| Polyps Detected | measured at the time of colonoscopy | Number of polyps |
| Patient Satisfaction With the Prep Measured by 5 Point Likert Scale | measured at check in to colonoscopy | patient satisfaction based on a Likert Scale from 0-5 (5 being completely satisfied and 0 being not satisfied) |
Countries
United States
Participant flow
Recruitment details
All pateints were recruited and enrolled at Brooke Army Medical Center in San Antonio, TX from July 1, 2009 to July 1, 2010.
Pre-assignment details
NO significant events occured prior to study participant enrollment.
Participants by arm
| Arm | Count |
|---|---|
| Miralax Plus Amitiza 106 patients randomized to Miralax plus Amitiza will take one 24mcg gelcap of Amitiza at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy. | 106 |
| Miralax Plus Dulcolax 107 patients randomized to Miralax plus Dulcolax will take two 5mg tablets of Dulcolax at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy. | 107 |
| Miralax 106 patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy. | 106 |
| Golytely (Polyethylene Glycol) 106 patients will take 1 gallon of golytley (Polyethylene glycol) and drink 1/2 of the solution at 4 p.m. The remaining 1/2 of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy | 106 |
| Total | 425 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Brown stool prior to procedure | 0 | 0 | 1 | 0 |
| Overall Study | DId not show up for colonoscopy | 4 | 4 | 5 | 4 |
| Overall Study | Incomplete data | 1 | 1 | 0 | 0 |
| Overall Study | Procedure incomplete due to pain/looping | 0 | 1 | 0 | 1 |
Baseline characteristics
| Characteristic | Miralax Plus Dulcolax | Miralax | Miralax Plus Amitiza | Golytely (Polyethylene Glycol) | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 2 Participants | 2 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 107 Participants | 106 Participants | 104 Participants | 104 Participants | 421 Participants |
| Age Continuous | 53.8 years STANDARD_DEVIATION 5.4 | 54.1 years STANDARD_DEVIATION 5.3 | 55.4 years STANDARD_DEVIATION 5.7 | 54.2 years STANDARD_DEVIATION 6.7 | 54 years STANDARD_DEVIATION 5.7 |
| Region of Enrollment United States | 107 participants | 106 participants | 106 participants | 106 participants | 425 participants |
| Sex: Female, Male Female | 48 Participants | 54 Participants | 55 Participants | 49 Participants | 206 Participants |
| Sex: Female, Male Male | 59 Participants | 52 Participants | 51 Participants | 57 Participants | 219 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 6 / 101 | 4 / 101 | 6 / 100 | 7 / 101 |
| serious Total, serious adverse events | 0 / 101 | 0 / 101 | 0 / 100 | 0 / 101 |
Outcome results
Primary
The Cleanliness of the Prep as Measured by the Ottawa Scale
Bowel cleansing was evaluated with the Ottawa bowel preparation scale by each endoscopist during the endoscopy. Neither the endoscopist nor the endoscopy nurse was aware of the bowel preparation used prior to the colonoscopy. The Ottawa bowel preparation scale is a validated tool and was used in this study to provide a reliable quality assessment of the bowel preparation used for colonoscopy. This validated scale rates each section of the colon, the right, the mid, and the rectosigmoid colon, on a 5-point scale (0-4), as well as a global 3-point rating for overall colonic fluid (0-2). The total score ranges from 0 to 14. An excellent preparation with little fluid would score 0-3, a good preparation 4-6, while scores higher than 7 would indicate progressively worsening bowel preparations. A completely unprepared colon would score 11-14, depending on the amount of colonic fluid.
Time frame: measured at the time of colonoscopy
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Miralax Plus Amitiza | The Cleanliness of the Prep as Measured by the Ottawa Scale | 6.3 Ottawa Scale |
| Miralax Plus Dulcolax | The Cleanliness of the Prep as Measured by the Ottawa Scale | 6.8 Ottawa Scale |
| Miralax | The Cleanliness of the Prep as Measured by the Ottawa Scale | 6.9 Ottawa Scale |
| Golytely (Polyethylene Glycol) | The Cleanliness of the Prep as Measured by the Ottawa Scale | 5.1 Ottawa Scale |
Secondary
Patient Satisfaction With the Prep Measured by 5 Point Likert Scale
patient satisfaction based on a Likert Scale from 0-5 (5 being completely satisfied and 0 being not satisfied)
Time frame: measured at check in to colonoscopy
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Miralax Plus Amitiza | Patient Satisfaction With the Prep Measured by 5 Point Likert Scale | 3.8 units on a scale | Standard Deviation 1.1 |
| Miralax Plus Dulcolax | Patient Satisfaction With the Prep Measured by 5 Point Likert Scale | 4.1 units on a scale | Standard Deviation 0.8 |
| Miralax | Patient Satisfaction With the Prep Measured by 5 Point Likert Scale | 4.0 units on a scale | Standard Deviation 1 |
| Golytely (Polyethylene Glycol) | Patient Satisfaction With the Prep Measured by 5 Point Likert Scale | 3.2 units on a scale | Standard Deviation 1 |
Secondary
Polyps Detected
Number of polyps
Time frame: measured at the time of colonoscopy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Miralax Plus Amitiza | Polyps Detected | 128 polyps |
| Miralax Plus Dulcolax | Polyps Detected | 92 polyps |
| Miralax | Polyps Detected | 90 polyps |
| Golytely (Polyethylene Glycol) | Polyps Detected | 101 polyps |
Secondary
Procedure Time
total colonoscopy procedure time
Time frame: measured at the time of colonoscopy
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Miralax Plus Amitiza | Procedure Time | 21.3 minutes | Standard Deviation 10.2 |
| Miralax Plus Dulcolax | Procedure Time | 19.3 minutes | Standard Deviation 8.1 |
| Miralax | Procedure Time | 20 minutes | Standard Deviation 9 |
| Golytely (Polyethylene Glycol) | Procedure Time | 18.3 minutes | Standard Deviation 7.2 |