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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
191
lubiprostone 24mcg gelcap, 1 gelcap taken at noon the day prior to the colonoscopy
placebo gelcap, taken at noon the day prior to the colonoscopy
Brooke Army Medical Center
Fort Sam Houston, Texas, United States
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)
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)
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)
The Number of Polyps Detected on Examination
The number of colon polyps detected during the colonoscopy.
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Time frame: measured upon completion of the colonoscopy, colonoscopies completed during the course of the study (approximately 4 month period)