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

NCT03410524 | Completed Phase 3 FDA Drug

• 1 other identifier: 1139179
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Colonoscopy

Keywords

Bowel wall visualization; Intraluminal bubbles; Intraluminal foam; Simethicone

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Boston Bowel Preparation Scale

  Data reported during colonoscopy.

• Cecal insertion time

  Data reported during colonoscopy.

• Withdrawal time

  Data reported during colonoscopy.

• Number of polyp

  Data reported during colonoscopy.

• Type of polyp

  Post colonoscopy pathology. Up until pathology data reporting. Estimated up to 2 weeks after colonoscopy.

Study Arms (2)

Simethicone with PEG-3350 bisacodyl preparation

ACTIVE COMPARATOR

Treatment arm: 200 mg Simethicone in 3 mL of liquid formulation mixed with low volume PEG-3350 bisacodyl combination preparation. Bowel preparation taken as per directions including the evening before and the day of the procedure.

Drug: Simethicone Solution

Placebo with PEG-3350 bisacodyl preparation

PLACEBO COMPARATOR

Placebo arm: 3 mL of water mixed with low volume PEG-3350 bisacodyl combination preparation. Bowel preparation taken as per directions including the evening before and the day of the procedure.

Drug: Water

Interventions

Simethicone Solution DRUG

200 mg of Simethicone in 3 mL of Simethicone Solution Formulation

Simethicone with PEG-3350 bisacodyl preparation

Water DRUG

3 mL of water as placebo added to the bowel preparation

Placebo with PEG-3350 bisacodyl preparation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Nevada, Reno: lead
• Gastroenterology Consultants: collaborator

Study Sites (2)

Gastroenterology Consultants Reno - North Office and Endoscopy Center

Reno, Nevada, 89502, United States

Location

Gastroenterology Consultants Reno - South Meadows Office and Endoscopy Center

Reno, Nevada, 89521, United States

Location

Related Publications (8)

• 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.

  PMID: 28944412 BACKGROUND

• 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.

  PMID: 26782820 BACKGROUND

• 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.

  PMID: 26232311 BACKGROUND

• 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. doi: 10.3748/wjg.15.3032.

  PMID: 19554657 BACKGROUND

• 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. doi: 10.1007/s00464-006-3037-1. No abstract available.

  PMID: 16799744 BACKGROUND

• 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. doi: 10.1007/BF02048160.

  PMID: 8137669 BACKGROUND

• 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.

  PMID: 26788258 BACKGROUND

• Brecevic L, Bosan-Kilibarda I, Strajnar F. Mechanism of antifoaming action of simethicone. J Appl Toxicol. 1994 May-Jun;14(3):207-11. doi: 10.1002/jat.2550140311.

  PMID: 8083482 BACKGROUND

MeSH Terms

Interventions

Water

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Eric Osgard, MD

  University of Nevada School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Endoscopist and patient blinded study.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident physician - Department of Internal Medicine

Study Record Dates

• First Submitted: January 9, 2018
• First Posted: January 25, 2018
• Study Start: January 9, 2018
• Primary Completion: October 31, 2018
• Study Completion: October 31, 2018
• Last Updated: December 12, 2018

Record last verified: 2018-12

Locations

US (2)