Colonoscopy Clinical Trial
Official title:
Simethicone Pretreatment With Low-volume Polyethylene Glycol-3350 and Bisacodyl in an Effort to Improve Bowel Wall Visualization During Colonoscopy
Verified date | December 2018 |
Source | University of Nevada, Reno |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 250 |
Est. completion date | October 31, 2018 |
Est. primary completion date | October 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Gastroenterology Consultants Reno - North Office and Endoscopy Center | Reno | Nevada |
United States | Gastroenterology Consultants Reno - South Meadows Office and Endoscopy Center | Reno | Nevada |
Lead Sponsor | Collaborator |
---|---|
University of Nevada, Reno | Gastroenterology Consultants |
United States,
Adams WJ, Meagher AP, Lubowski DZ, King DW. Bisacodyl reduces the volume of polyethylene glycol solution required for bowel preparation. Dis Colon Rectum. 1994 Mar;37(3):229-33; discussion 233-4. — View Citation
American Society of Colon and Rectal Surgeons (ASCRS); American Society for Gastrointestinal Endoscopy (ASGE); Society of American Gastrointestinal and Endoscopic Surgeons (SAGES), Wexner SD, Beck DE, Baron TH, Fanelli RD, Hyman N, Shen B, Wasco KE. A consensus document on bowel preparation before colonoscopy: prepared by a Task Force from the American Society of Colon and Rectal Surgeons (ASCRS), the American Society for Gastrointestinal Endoscopy (ASGE), and the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES). Surg Endosc. 2006 Jul;20(7):1161. — View Citation
Brecevic L, Bosan-Kilibarda I, Strajnar F. Mechanism of antifoaming action of simethicone. J Appl Toxicol. 1994 May-Jun;14(3):207-11. — View Citation
Harrison NM, Hjelkrem MC. Bowel cleansing before colonoscopy: Balancing efficacy, safety, cost and patient tolerance. World J Gastrointest Endosc. 2016 Jan 10;8(1):4-12. doi: 10.4253/wjge.v8.i1.4. Review. — View Citation
Kojecky V, Matous J, Keil R, Dastych M, Kroupa R, Zadorova Z, Varga M, Dolina J, Kment M, Hep A. A head-to-head comparison of 4-L polyethylene glycol and low-volume solutions before colonoscopy: which is the best? A multicentre, randomized trial. Int J Colorectal Dis. 2017 Dec;32(12):1763-1766. doi: 10.1007/s00384-017-2901-x. Epub 2017 Sep 24. — View Citation
Parente F, Vailati C, Bargiggia S, Manes G, Fontana P, Masci E, Arena M, Spinzi G, Baccarin A, Mazzoleni G, Testoni PA. 2-Litre polyethylene glycol-citrate-simethicone plus bisacodyl versus 4-litre polyethylene glycol as preparation for colonoscopy in chronic constipation. Dig Liver Dis. 2015 Oct;47(10):857-63. doi: 10.1016/j.dld.2015.06.008. Epub 2015 Jul 6. — View Citation
Parmar R, Martel M, Rostom A, Barkun AN. Validated Scales for Colon Cleansing: A Systematic Review. Am J Gastroenterol. 2016 Feb;111(2):197-204; quiz 205. doi: 10.1038/ajg.2015.417. Epub 2016 Jan 19. Review. — View Citation
Tongprasert S, Sobhonslidsuk A, Rattanasiri S. Improving quality of colonoscopy by adding simethicone to sodium phosphate bowel preparation. World J Gastroenterol. 2009 Jun 28;15(24):3032-7. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intraluminal Bubbles Scale | I >90% of the mucosal circumference seen II 90%-75% of the mucosal seen without foam or bubbles not requiring irrigation III 74% to 50% of the mucosa is free of foam or bubbles. Required irrigation IV <50% of the mucosa seen free of foam or bubbles. Required irrigation | Data reported during colonoscopy. | |
Secondary | Boston Bowel Preparation Scale | Data reported during colonoscopy. | ||
Secondary | Cecal insertion time | Data reported during colonoscopy. | ||
Secondary | Withdrawal time | Data reported during colonoscopy. | ||
Secondary | Number of polyp | Data reported during colonoscopy. | ||
Secondary | Type of polyp | Post colonoscopy pathology. Up until pathology data reporting. Estimated up to 2 weeks after colonoscopy. | ||
Secondary | Type of masses | Post colonoscopy pathology. Up until pathology data reporting. Estimated up to 2 weeks after colonoscopy. | ||
Secondary | Number of masses | Data reported during colonoscopy. | ||
Secondary | Adverse effects | From the time of administration of the bowel preparation (day prior to colonoscopy) up until the time of the procedure preparation (pre-colonoscopy preparation). Estimated period of up to 24 hours. |
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