The purpose of this study is to determine whether the administration of PEG along with simethicone will reduce the incidence of colonic bubbles that interfere with polyp detection.
evaluating if simethicone is better than placebo at decreasing gas in the colon at time of colonoscopy so that it is easier for the endoscopist to see polyps
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
140
400 mg simethicone at 6pm night prior to colonoscopy 400 mg simethicone 4 hours before colonoscopy
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Efficacy - Entire colon
Successful cleansing defined as score or excellent or good Unsuccessful cleansing defined as score of fair or inadequate
Time frame: At time of colonoscopy
Efficacy - Right colon
Successful cleansing defined as score or excellent or good Unsuccessful cleansing defined as score of fair or inadequate
Time frame: At time of colonoscopy
Adenoma detection
Defined as number of adenoma/patient Secondarily evaluate % of patients with at least 1 adenoma
Time frame: at time of colonoscopy
Flushing
Defined as need for any (1, 2, or 3) flushing • 0 = none, 1 = \<50 ml, 2 = 50-100 ml, 3 = \>100 ml
Time frame: at time of colonoscopy
Tolerance
Prep completion • Completion defined as consuming \> 90% Sleep * Primary definition as quality of sleep * Also evaluate duration of sleep Overall satisfaction * Use visual analogue (Likert) scale Adverse events - nausea, vomiting, abdominal pain, bloating, light-headedness * Primary is incidence * Secondary is severity using Likert scale
Time frame: during prep ingestion
Safety
Vitals with orthostatic measures (BP, Pulse) day of colonoscopy Physical exam
Time frame: at time of colonoscopy
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