Evaluation of Oral Simethicone With Low Volume Polyethylene Glycol Bowel Preparation During Colonoscopy
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 12/14/2018 |
| Start Date: | January 9, 2018 |
| End Date: | October 31, 2018 |
Simethicone Pretreatment With Low-volume Polyethylene Glycol-3350 and Bisacodyl in an Effort to Improve Bowel Wall Visualization During Colonoscopy
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.
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.
This prospective, multi-center, randomized, controlled, double (patient and endoscopist)
blinded study is conducted at the Gastroenterology Consultants outpatient clinics and
endoscopy centers in association with the University of Nevada-Reno School of Medicine. After
obtaining signed informed consent, outpatients are recruited and randomized into 1 of 2
treatment groups; PEG3350-Bisacodyl with 200 mg liquid simethicone treatment and
PEG3350-Bisacodyl treatment with inert placebo (water).
The primary outcome includes reduction of bubbles using the intraluminal bubbles scale.
Secondary outcomes include the evaluations of the numbers and types of polyps, numbers and
types of masses detected, cecal insertion time, withdrawal time, adverse effects, and the
adequacy of bowel prep using the Boston Bowel Prep scale.
blinded study is conducted at the Gastroenterology Consultants outpatient clinics and
endoscopy centers in association with the University of Nevada-Reno School of Medicine. After
obtaining signed informed consent, outpatients are recruited and randomized into 1 of 2
treatment groups; PEG3350-Bisacodyl with 200 mg liquid simethicone treatment and
PEG3350-Bisacodyl treatment with inert placebo (water).
The primary outcome includes reduction of bubbles using the intraluminal bubbles scale.
Secondary outcomes include the evaluations of the numbers and types of polyps, numbers and
types of masses detected, cecal insertion time, withdrawal time, adverse effects, and the
adequacy of bowel prep using the Boston Bowel Prep scale.
Inclusion Criteria:
- Eligible for outpatient elective colonoscopy
- Adult 18-80 years of age able to give consent.
- English speaking adults.
Exclusion Criteria:
- History of bowel resection
- Uncontrolled hypertension
- Suspected bowel perforation
- Suspected bowel obstruction
- Indications for emergent/urgent colonoscopy
- Non-english speaking individuals
We found this trial at
2
sites
880 Ryland Street
Reno, Nevada 89502
Reno, Nevada 89502
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10619 Professional Circle
Reno, Nevada 89521
Reno, Nevada 89521
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