An interventional study of simethicone in Bubbles in Colon at Time of Colonoscopy, sponsored by Thomas Jefferson University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-15.
Sponsored by Thomas Jefferson University · Not applicable, Interventional, and Other
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
Thomas Jefferson University is the lead sponsor of 384 studies on the registry; 71 are open to participants now.
Of its 44 completed or terminated interventional studies of FDA-regulated products, 20 (45%) have results posted.
Counted across the registry records on this site, refreshed daily.
-Elective outpatients undergoing colonoscopy using split dose PEG-ELS with sodium ascorbate and ascorbic acid
Exclusion Criteria:
Drug: simethicone
400 mg simethicone at 6pm night prior to colonoscopy 400 mg simethicone 4 hours before colonoscopy
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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
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Thomas Jefferson University