Bubbles in Colon at Time of Colonoscopy
Conditions
Brief summary
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.
Detailed description
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
Interventions
DRUGsimethicone
400 mg simethicone at 6pm night prior to colonoscopy 400 mg simethicone 4 hours before colonoscopy
Sponsors
Thomas Jefferson University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
-Elective outpatients undergoing colonoscopy using split dose PEG-ELS with sodium ascorbate and ascorbic acid
Exclusion criteria
* Unable or unwilling to give informed consent * Age \< 18 years * Pregnant * Breast feeding * Established or suspected gastroparesis * Pseudo-obstruction - established or suspected * Severe constipation (\< 1 BM a week) * Bowel obstruction * Greater than 50% resection of colon * Chronic nausea or vomiting * Consumed \> 100% standard dose of PEG-ELS (i.e. more than 2L) * G6PD deficiency * PEG allergy * Significant psychiatric illness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy - Entire colon | At time of colonoscopy | Successful cleansing defined as score or excellent or good Unsuccessful cleansing defined as score of fair or inadequate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy - Right colon | At time of colonoscopy | Successful cleansing defined as score or excellent or good Unsuccessful cleansing defined as score of fair or inadequate |
| Adenoma detection | at time of colonoscopy | Defined as number of adenoma/patient Secondarily evaluate % of patients with at least 1 adenoma |
| Flushing | at time of colonoscopy | Defined as need for any (1, 2, or 3) flushing • 0 = none, 1 = \<50 ml, 2 = 50-100 ml, 3 = \>100 ml |
| Tolerance | during prep ingestion | 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 |
| Safety | at time of colonoscopy | Vitals with orthostatic measures (BP, Pulse) day of colonoscopy Physical exam |
Countries
United States
Outcome results
None listed