Bowel Preparation for Colonoscopy
Conditions
Brief summary
The primary outcomes of this procedure will be: 1. The cleanliness of the prep as measured by the Ottawa Scale (attachment a). Secondary outcomes will be: 1. Patient satisfaction with the prep measured by 5 point Likert scale (attachment b); 2. Procedure time; 3. The number and size of polyps detected on examination.
Interventions
DRUGlubiprostone
lubiprostone 24mcg gelcap, 1 gelcap taken at noon the day prior to the colonoscopy
DRUGplacebo
placebo gelcap, taken at noon the day prior to the colonoscopy
Sponsors
Takeda
Brooke Army Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, 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 * Ages will be from 18 years of age and older
Exclusion criteria
* Chronic kidney disease * Previous diagnosis of congestive heart failure * History of bowel obstruction * History of solid organ transplant * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Overall Cleanliness of the Prep as Measured by the Ottawa Scale | measured upon completion of the colonoscopy, colonoscopies completed during the course of the study (approximately 4 month period) | 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 7would 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 |
|---|---|---|
| Patient Satisfaction With the Prep Measured by 5 Point Likert Scale | measured after completion of the bowel preparation and prior to the colonoscopy, completed during the course of the study (approximately 4 month period) | The participants completed a survey prior to the colonoscopy that graded their overall satisfaction with the bowel preparation. The subjects rated the survey questions on a 5-point Likert scale where 1 = severely distressing, 2=distressing, 3=bothersome, 4=mild, and 5=none. |
| Procedure Time | measured upon completion of the colonoscopy, colonoscopies completed during the course of the study (approximately 4 month period) | Procedure time refers to the total length of time required to complete the colonoscopy |
| The Number of Polyps Detected on Examination | measured upon completion of the colonoscopy, colonoscopies completed during the course of the study (approximately 4 month period) | The number of colon polyps detected during the colonoscopy. |
Countries
United States
Participant flow
Recruitment details
Gastroenterology Clinic, Brooke Army Medical Center, Fort Sam Houston, TX October 2007 to January 2008
Participants by arm
| Arm | Count |
|---|---|
| Amitiza split-dose PEG solution without dietary restrictions plus lubiprostone 24mcg gelcap pretreatment | 95 |
| Placebo split-dose PEG solution without dietary restrictions plus placebo pretreatment | 96 |
| Total | 191 |
Baseline characteristics
| Characteristic | Placebo | Amitiza | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 96 Participants | 94 Participants | 190 Participants |
| Age Continuous | 55.9 years STANDARD_DEVIATION 4.8 | 55.4 years STANDARD_DEVIATION 5.2 | 55.5 years STANDARD_DEVIATION 5 |
| Region of Enrollment United States | 96 participants | 95 participants | 191 participants |
| Sex: Female, Male Female | 45 Participants | 48 Participants | 93 Participants |
| Sex: Female, Male Male | 51 Participants | 47 Participants | 98 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 94 | 0 / 94 |
| serious Total, serious adverse events | 0 / 94 | 0 / 94 |
Outcome results
Primary
The Overall 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 7would indicate progressively worsening bowel preparations. A completely unprepared colon would score 11-14, depending on the amount of colonic fluid
Time frame: measured upon completion of the colonoscopy, colonoscopies completed during the course of the study (approximately 4 month period)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Amitiza | The Overall Cleanliness of the Prep as Measured by the Ottawa Scale | 4.8 Ottawa Score |
| Placebo | The Overall Cleanliness of the Prep as Measured by the Ottawa Scale | 6.2 Ottawa Score |
Secondary
Patient Satisfaction With the Prep Measured by 5 Point Likert Scale
The participants completed a survey prior to the colonoscopy that graded their overall satisfaction with the bowel preparation. The subjects rated the survey questions on a 5-point Likert scale where 1 = severely distressing, 2=distressing, 3=bothersome, 4=mild, and 5=none.
Time frame: measured after completion of the bowel preparation and prior to the colonoscopy, completed during the course of the study (approximately 4 month period)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amitiza | Patient Satisfaction With the Prep Measured by 5 Point Likert Scale | 3.7 linkert scale (1-5) | Standard Deviation 1 |
| Placebo | Patient Satisfaction With the Prep Measured by 5 Point Likert Scale | 3.2 linkert scale (1-5) | Standard Deviation 1.1 |
Secondary
Procedure Time
Procedure time refers to the total length of time required to complete the colonoscopy
Time frame: measured upon completion of the colonoscopy, colonoscopies completed during the course of the study (approximately 4 month period)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amitiza | Procedure Time | 17.8 minutes | Standard Deviation 5.4 |
| Placebo | Procedure Time | 19.8 minutes | Standard Deviation 6.2 |
Secondary
The Number of Polyps Detected on Examination
The number of colon polyps detected during the colonoscopy.
Time frame: measured upon completion of the colonoscopy, colonoscopies completed during the course of the study (approximately 4 month period)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Amitiza | The Number of Polyps Detected on Examination | 48 number of polyps |
| Placebo | The Number of Polyps Detected on Examination | 44 number of polyps |