Randomized clinical trial comparing fixed-time split dosing and split dosing of oral Picosulfate regimen for bowel preparatio

Not Applicable

Completed

Conditions: Not Applicable

Registration Number: KCT0002348

Lead Sponsor: GangNeung Asan Hospital

Brief Summary: 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).

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 240

Inclusion Criteria

Health screening, Family history of Colon cancer, Irritable bowel syndrome, follow up for Colon polyp

Exclusion Criteria

1) pregnant women; 2) acute abdomen; 3) history of dehydration and /or drug allergy; 4) congestive heart failure; 5) chronic liver disease or renal insufficiency; 6) history of colon resection or abdominal surgery within six months; 7) participation in other clinical studies within four weeks prior to randomization.