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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| simethicone | Active Comparator |
| |
| no simethicone | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| simethicone | Drug | 400 mg simethicone at 6pm night prior to colonoscopy 400 mg simethicone 4 hours before colonoscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy - Entire colon | Successful cleansing defined as score or excellent or good Unsuccessful cleansing defined as score of fair or inadequate | At time of colonoscopy |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy - Right colon | Successful cleansing defined as score or excellent or good Unsuccessful cleansing defined as score of fair or inadequate | At time of colonoscopy |
| Adenoma detection | Defined as number of adenoma/patient Secondarily evaluate % of patients with at least 1 adenoma |
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Inclusion Criteria:
-Elective outpatients undergoing colonoscopy using split dose PEG-ELS with sodium ascorbate and ascorbic acid
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Kastenberg, MD | Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 1, 2019 | |
| Reset | Aug 21, 2019 | |
| Release | Nov 28, 2023 | |
| Reset | Dec 19, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 1, 2019 | Aug 21, 2019 | |||
| Nov 28, 2023 |
| ID | Term |
|---|---|
| D012841 | Simethicone |
| ID | Term |
|---|---|
| D004129 | Dimethylpolysiloxanes |
| D012828 | Silicones |
| D012833 | Siloxanes |
| D017646 | Organosilicon Compounds |
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| 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 | at time of colonoscopy |
| Tolerance | Prep completion • Completion defined as consuming > 90% Sleep
| during prep ingestion |
| Safety | Vitals with orthostatic measures (BP, Pulse) day of colonoscopy Physical exam | at time of colonoscopy |
| Dec 19, 2023 |
| D009930 |
| Organic Chemicals |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |