Evaluation of Oral Simethicone With Low Volume Polyethylene Glycol Bowel Preparation During Colonoscopy

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03410524
• Other study ID #: 1139179
• Status: Completed
• Phase: Phase 3
• Start date: January 9, 2018
• Est. completion date: October 31, 2018

Study information

• Verified date: December 2018
• Source: University of Nevada, Reno
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Colonoscopy

Intervention

Drug:
• Simethicone Solution
200 mg of Simethicone in 3 mL of Simethicone Solution Formulation
• Water
3 mL of water as placebo added to the bowel preparation

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University of Nevada, Reno	Gastroenterology Consultants

Country where clinical trial is conducted

United States, 

References & Publications (8)

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

Outcome

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.