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

NCT ID: NCT03410524

Last Updated: 2018-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-09

Study Completion Date

2018-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Colonoscopy

Keywords

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Bowel wall visualization Intraluminal bubbles Intraluminal foam Simethicone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
Endoscopist and patient blinded study.

Study Groups

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Simethicone with PEG-3350 bisacodyl preparation

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.

Group Type ACTIVE_COMPARATOR

Simethicone Solution

Intervention Type DRUG

200 mg of Simethicone in 3 mL of Simethicone Solution Formulation

Placebo with PEG-3350 bisacodyl preparation

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.

Group Type PLACEBO_COMPARATOR

Water

Intervention Type DRUG

3 mL of water as placebo added to the bowel preparation

Interventions

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Simethicone Solution

200 mg of Simethicone in 3 mL of Simethicone Solution Formulation

Intervention Type DRUG

Water

3 mL of water as placebo added to the bowel preparation

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gastroenterology Consultants

UNKNOWN

Sponsor Role collaborator

University of Nevada, Reno

OTHER

Sponsor Role lead

Responsible Party

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Mohit Rishi

Resident physician - Department of Internal Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eric Osgard, MD

Role: PRINCIPAL_INVESTIGATOR

University of Nevada School of Medicine

Locations

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Gastroenterology Consultants Reno - North Office and Endoscopy Center

Reno, Nevada, United States

Site Status

Gastroenterology Consultants Reno - South Meadows Office and Endoscopy Center

Reno, Nevada, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 28944412 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26782820 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26232311 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19554657 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16799744 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8137669 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26788258 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8083482 (View on PubMed)

Other Identifiers

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1139179

Identifier Type: -

Identifier Source: org_study_id