Evaluation of Oral Simethicone With Low Volume Polyethylene Glycol Bowel Preparation During Colonoscopy
Completed · Phase 3 · Has a placebo group
Conditions studied: Colonoscopy
In brief
An adequate bowel preparation has been well established to lead to a successful colonoscopy. Research has consistently demonstrated inadequate bowel preparation with lower adenoma detection rates. Over the years, endoscopy centers have changed the constituents of bowel preparation in light of new research. In 2006, 3 medical organizations recommended the use of polyethylene glycol (PEG) solution for bowel preparation. Initially, a 4 liter PEG solution was commonly used using a split dose regimen for bowel prep. However, many patients found that this large volume gave them side effects including bloating and cramping. Other studies showed that a low volume PEG solution with oral bisacodyl fared equally in terms of adequacy of bowel preparation. With the institution of lower volume PEG preparation our offices noted improved patient toleration, satisfaction, and clinical outcomes. However, multiple endoscopists have noticed an increased in intraluminal bubbles and foam with the low volume preparation. This can impair proper visualization of the bowel wall even with an adequate bowel preparation. The current standard of practice includes irrigation, lavage, and suctioning using a simethicone infused saline during the colonoscopy. Its property of reducing surface tension to help dissolve bubbles and clear the field of view is vital during the procedure. Furthermore, it does not dissolve into the blood stream and thereby, is considered rather safe. This study evaluates whether the addition of oral simethicone with the colonoscopy bowel preparation reduces bubbles and foam during the procedure using a randomized and controlled interventional study.
Key facts
- Study ID
- NCT03410524
- Run by
- University of Nevada, Reno
- People needed
- 250
- Starts
- 2018-01-09
- Expected to finish
- 2018-10-31
- Last updated by the study team
- 2018-12-12
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Eligible for outpatient elective colonoscopy
- Adult 18-80 years of age able to give consent.
- English speaking adults.
You may not qualify if…
- History of bowel resection
- Uncontrolled hypertension
- Suspected bowel perforation
- Suspected bowel obstruction
- Indications for emergent/urgent colonoscopy
- Non-english speaking individuals
Where it is running
- Gastroenterology Consultants Reno - North Office and Endoscopy Center — Reno, Nevada, United States
- Gastroenterology Consultants Reno - South Meadows Office and Endoscopy Center — Reno, Nevada, United States
Full record on ClinicalTrials.gov
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