A Blinded Clinical Trial comparing the Efficacy and Tolerability of Picolight(fixed split dose regimen) for colonoscopy

In this prospective, randomized, investigator-blinded study, we enrolled 240 patients between August 2014 and November 2015. Of the 240 patients randomized, 36 were excluded due to the following: failure to complete bowel preparation as advised (n=16); failure to cecal intubation due to abdominal pain or vomiting, colon cancer (n=3); withdrawal of consent (n=10, fixed-time split dose group; 5, split dose group; 5); and a completely unprepared colon (n=7, fixed-time split dose group; 4, split dose group; 3). Ultimately, 99 patients in the fixed-time split dose group and 105 in the split dose group completed the study and were analyzed (Fig.1). The characteristics of the patients in the two groups are shown in Table 1. There were no statistical difference between the two groups with respect to gender, height, weight, mean age, BMI, and/or history of abdominal surgery and DM (Tab.1). Quality of bowel preparation Using the Ottawa Bowel Preparation Scale, the mean Ottawa score was 2.57±1.91 in the fixed-time split dose preparation and 2.80±2.51 in the split dose preparation (p=0.457)(Fig 2, Tab 3). Cecal intubation time and physician's satisfaction of the inspection were not significantly different between the two groups (p=0.428, p=0.489) (Tab.2). On subgroup analysis of fixed-time split dose preparation, there was no difference of mean Ottawa score between the morning colonoscopy (9:30 to 11:30 am) and the afternoon (1:00~ 3:00 pm.) colonoscopy groups (2.56±1.78 vs. 2.59±2.27, p = 0.932) (Fig.3). Tolerability of the preparation and sleep disturbance Nausea was complained of in 21.2% of the patients with the fixed-time split dose preparation and in 14.3% with split dose preparation (p=0.136). Vomiting was reported by 7.1% and 2.9% (p=0.164), abdominal discomfort by 7.1% and 4.8% (p=0.484), dizziness by 1% and 4.8% (p=0.113), cold sweating by 1% and 0% (p=0.302) and palpitation by 0% and 1% (p=0.330), respectively. Sleep was disturbed in two(2%) patients in the-fixed time split dose preparation and zero(0%) patients in the split dose preparation (p=0.143) groups (Tab. 2).