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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03410524
Other study ID # 1139179
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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.
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