Eligible subjects undergoing a colonoscopy will randomly receive either PICOPREP or polyethylene glycol 4000 electrolyte lavage solution before the procedure to evaluate its effectiveness, tolerability and safety.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
300
Nanfang Hospital, Southern Medical University
Guangzhou, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, China
Drum Tower Hospital
Nanjing, China
Changhai Hospital, The Second Military Medical University
Shanghai, China
The Ottawa Scale Score of Patients Who Had Successfully Completed the Colonoscopy Examination After Having Completed the Study Bowel Preparation
The total Ottawa Bowel Preparation Scale (OBPS) score, rated by the treatment-blinded Investigator at colonoscopy, was designed to evaluate cleanliness of the colon by grading the endoscopic visibility of the mucosa according to a scale from 0 ('excellent' visibility) to 4 ('inadequate' visibility); The component scores for each of the colon segment are added together, along with an overall 'fluid' score (from small amount = 0, to large amount = 2). Thus, the total OBPS has a range from 0 (a perfect preparation) to 14 (a completely unprepared bowel)
Time frame: day 2
Patient Response to Acceptability and Tolerability Questionnaire
On the day of the procedure, but before colonoscopy or any sedation for colonoscopy, subjects were asked to complete a standardised questionnaire regarding whether or not complete the IMP (yes or no), ease of taking IMP (rating from 1 point(very easy) to 5 point (very difficult)), degree of acceptability to study med (rating from 1 point (excellent) to 5 point (bad)), palatability of IMP (rating from 1 point (excellent) to 5 point (bad)) and tolerability (5 adverse reactions including abdominal bloating, spasms, nausea, vomiting and general malaise which were generally reported in bowel preparation with rating according to intensity from 1 point (None) to 4 point (Severe)).
Time frame: Day 2
Ottawa Scale Score by Colon Segment
Mean Ottawa Scale scores, and score categories (from 'excellent' to 'bad'), are summarised by colon segment together with the overall fluid content score
Time frame: Day 2
Percentage of Successful Completion of Colonoscopy
An overview of completion rates of colonoscopy (i.e., endoscope reaching the ileocecal valve)
Time frame: Day 2
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Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, China
Huazhong Technological University Tongji Medical College Affiliated Union Hospital
Wuhan, China
Proportion of Successful Colonoscopies in the Clinical Setting (Predicted by Ottawa Scale Score)
At colonoscopy, bowel preparations were rated by the treatment-blinded endoscopist, as being of an overall quality "adequate for clinical diagnostic purposes" (Y/N). The total Ottawa Scale scores was correlated with 'adequate' or 'inadequate' quality of bowel preparation for clinical diagnostic purposes
Time frame: Day 2
Proportion of Subjects Requiring a Repeat Colonoscopy Due to Poor Bowel Preparation
The Proportion of subjects requiring a repeat colonoscopy due to poor bowel preparation
Time frame: Day 2