Comparison of Bowel Cleansing Efficacy Between Same-day Dose Versus Split Dose
Status:
Completed
Trial end date:
2018-02-28
Target enrollment:
Participant gender:
Summary
Split dose bowel cleansing is recommended method for colonoscopy. For afternoon colonoscopy,
same-day dose of bowel cleansing is alternative option. Recently, same-day bowel cleansing
for morning colonoscopy was validated. To date, there was no study which compared the bowel
cleansing efficacy between same-day dose and split dose regardless of colonoscopy time. The
aim of current study is to compare the bowel cleansing efficacy, adverse events, and
patient's tolerability between the two group.
Subjects who underwent colonoscopy for various reasons were included. After agreeing to
participate in the study, study participants were randomly assigned to split dose or same day
dose group. Bowel cleansing is done using polyethylene glycol (PEG). All colonoscopy was done
between 10 AM to 6 PM. Study participants were instructed to ingest 500ml PEG every 15
minutes. Subjects who were assigned to split dose group ingested 2L PEG from 9PM 1 day before
colonoscopy. Remaining 2L PEG was ingested 3-5 hours before colonoscopy. In the same-day dose
group, bowel cleansing was started from 5AM for subjects who were scheduled to receive
colonoscopy in the morning. Afternoon colonoscopy group in the same-day dose group ingested
2L PEG from 5AM. Remaining 2L PEG was finished 3-5 hours before colonoscopy.
Bowel cleansing efficacy was assessed using Boston bowel preparation scale. Vital signs and
laboratory tests were checked before colonoscopy. Study participants completed questionnaire
which contained patient's satisfaction, tolerability, and adverse event during bowel
cleansing. Bowel cleansing efficacy, patient's tolerability, and safety profile were compared
between the two groups. Successful bowel cleansing was estimated 85% for split dose group.
The investigators set 10% for inferior margin. Considering 10% drop out, a total of 352
subjects will be recruited.