Efficacy and Tolerability of Suprep With and Without Simethicone for Routine Colonoscopy for Colorectal Cancer Screening

NCT02523911 | Withdrawn DMC

• 1 other identifier: MMC2015-31
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to investigate Suprep bowel preparation, with and without the anti-gas medication simethicone, in terms of efficacy and patient tolerability in the preparation of patients undergoing routine colonoscopy for colorectal cancer screening.

Conditions

Colorectal Cancer

Keywords

Suprep; Simethicone; Colorectal cancer screening; Routine colonoscopy; sodium sulfate/potassium sulfate/magnesium sulfate; Bowel cleansing; Mass screening

Outcome Measures

Primary Outcomes (1)

• Overall bowel cleansing

  To be assessed during removal of the colonoscope during the procedure and blinded endoscopist will score using a written questionnaire

  During procedure

Secondary Outcomes (2)

• Number of patients with adverse effects

  Day prior to and day of colonoscopy

• Number of patients completing the bowel preparation

  Day prior to and day of colonoscopy

Other Outcomes (2)

• Presence of bubbles

  During procedure

• Degree of haziness

  During procedure

Study Arms (2)

Simethicone Group

ACTIVE COMPARATOR

Early in the evening prior to colonoscopy, patients will be instructed to consume one 6 ounce bottle of oral sodium sulfate/potassium sulfate/magnesium sulfate (Suprep) solution (containing sodium sulfate 17.5 grams, potassium sulfate 3.13 grams, and magnesium sulfate 1.6 grams) diluted with 16 ounces of water over one hour. Over the next hour, the patient will be instructed to drink an additional 32 ounces of water. On the day of colonoscopy, the same procedure will be repeated. Patients will take 2.4 mL simethicone in a half glass of water immediately after consuming each dose of the Suprep. All of the bowel preparation solution and required water should be consumed at least 2 hours prior to colonoscopy.

Drug: Simethicone; Drug: sodium sulfate/potassium sulfate/magnesium sulfate solution

Placebo Group

PLACEBO COMPARATOR

Early in the evening prior to colonoscopy, patients will be instructed to consume one 6 ounce bottle of oral sodium sulfate/potassium sulfate/magnesium sulfate (Suprep) solution (containing sodium sulfate 17.5 grams, potassium sulfate 3.13 grams, and magnesium sulfate 1.6 grams) diluted with 16 ounces of water over one hour. Over the next hour, the patient will be instructed to drink an additional 32 ounces of water. On the day of colonoscopy, the same procedure will be repeated. Patients will take 2.4 mL of placebo (identical in appearance to simethicone) in a half glass of water immediately after consuming each dose of the Suprep. All of the bowel preparation solution and required water should be consumed at least 2 hours prior to colonoscopy.

Drug: Placebo; Drug: sodium sulfate/potassium sulfate/magnesium sulfate solution

Interventions

Simethicone DRUG

Patients will be randomized to receive either simethicone or placebo in addition to oral sodium sulfate/potassium sulfate/magnesium sulfate solution (Suprep), and will be blinded to whether they are in the simethicone arm or the placebo arm of the trial. Simethicone and placebo will be prepared as identically-appearing liquid solution (2.4 mL) with the assistance of a pharmacist. The simethicone or placebo solution will then be assigned to patients according to the randomization scheme and samples will be labeled with patient information prior to distribution. Only the pharmacist will participate in the labeling process and know which patients receive simethicone or placebo; administering staff, nurses, physicians, and patients will be blinded to this.

Also known as: Gas-X Infant Drops, Infants Gas Relief, Infants Simethicone, Infants' Mylicon

Simethicone Group

Placebo DRUG

Patients will be randomized to receive either simethicone or placebo in addition to oral sodium sulfate/potassium sulfate/magnesium sulfate solution (Suprep), and will be blinded to whether they are in the simethicone arm or the placebo arm of the trial. Simethicone and placebo will be prepared as identically-appearing liquid solution (2.4 mL) with the assistance of a pharmacist. The simethicone or placebo solution will then be assigned to patients according to the randomization scheme and samples will be labeled with patient information prior to distribution. Only the pharmacist will participate in the labeling process and know which patients receive simethicone or placebo; administering staff, nurses, physicians, and patients will be blinded to this.

Also known as: Inert solution

Placebo Group

sodium sulfate/potassium sulfate/magnesium sulfate solution DRUG

Both arms will receive sodium sulfate/potassium sulfate/magnesium sulfate solution for bowel preparation

Also known as: Suprep Bowel Prep Kit

Placebo Group; Simethicone Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than 18 years
• Outpatients who require elective colonoscopy for colorectal cancer screening at Iowa Endoscopy Center and at University of Florida - Jacksonville

You may not qualify if:

• Allergy or hypersensitivity to any constituent of the lavage solution or to simethicone
• Presence of any contraindication to colonoscopy (i.e. uncontrolled congestive heart failure, New York Heart Association classification III-IV, history of myocardial infarction within 6 months, coagulopathy)
• Massive ascites
• Renal insufficiency
• Pregnancy
• History of colonic surgery
• History of anti-flatulence or laxative agent within one week
• Refusal/inability to give consent
• Patients undergoing colonoscopy for reasons other than colorectal cancer screening
• Mentally disabled
• Non-English-speaking patients

Sponsors & Collaborators

• MercyOne Des Moines Medical Center: lead

Study Sites (2)

UF Health Jacksonville

Jacksonville, Florida, 32209, United States

Location

Iowa Endoscopy Center

Clive, Iowa, 50325, United States

Location

Related Publications (14)

• Valiante F, Bellumat A, De Bona M, De Boni M. Bisacodyl plus split 2-L polyethylene glycol-citrate-simethicone improves quality of bowel preparation before screening colonoscopy. World J Gastroenterol. 2013 Sep 7;19(33):5493-9. doi: 10.3748/wjg.v19.i33.5493.

  PMID: 24023492 BACKGROUND

• Gentile M, De Rosa M, Cestaro G, Forestieri P. 2 L PEG plus ascorbic acid versus 4 L PEG plus simethicon for colonoscopy preparation: a randomized single-blind clinical trial. Surg Laparosc Endosc Percutan Tech. 2013 Jun;23(3):276-80. doi: 10.1097/SLE.0b013e31828e389d.

  PMID: 23751992 BACKGROUND

• Pontone S, Angelini R, Standoli M, Patrizi G, Culasso F, Pontone P, Redler A. Low-volume plus ascorbic acid vs high-volume plus simethicone bowel preparation before colonoscopy. World J Gastroenterol. 2011 Nov 14;17(42):4689-95. doi: 10.3748/wjg.v17.i42.4689.

  PMID: 22180711 BACKGROUND

• Jansen SV, Goedhard JG, Winkens B, van Deursen CT. Preparation before colonoscopy: a randomized controlled trial comparing different regimes. Eur J Gastroenterol Hepatol. 2011 Oct;23(10):897-902. doi: 10.1097/MEG.0b013e32834a3444.

  PMID: 21900786 BACKGROUND

• Park JJ, Lee SK, Jang JY, Kim HJ, Kim NH. The effectiveness of simethicone in improving visibility during colonoscopy. Hepatogastroenterology. 2009 Sep-Oct;56(94-95):1321-5.

  PMID: 19950784 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

• Sudduth RH, DeAngelis S, Sherman KE, McNally PR. The effectiveness of simethicone in improving visibility during colonoscopy when given with a sodium phosphate solution: a double-bind randomized study. Gastrointest Endosc. 1995 Nov;42(5):413-5. doi: 10.1016/s0016-5107(95)70041-2.

  PMID: 8566629 BACKGROUND

• Lazzaroni M, Petrillo M, Desideri S, Bianchi Porro G. Efficacy and tolerability of polyethylene glycol-electrolyte lavage solution with and without simethicone in the preparation of patients with inflammatory bowel disease for colonoscopy. Aliment Pharmacol Ther. 1993 Dec;7(6):655-9. doi: 10.1111/j.1365-2036.1993.tb00148.x.

  PMID: 8161673 BACKGROUND

• Shaver WA, Storms P, Peterson WL. Improvement of oral colonic lavage with supplemental simethicone. Dig Dis Sci. 1988 Feb;33(2):185-8. doi: 10.1007/BF01535731.

  PMID: 3338367 BACKGROUND

• Wexner SD, Beck DE, Baron TH, Fanelli RD, Hyman N, Shen B, Wasco KE; American Society of Colon and Rectal Surgeons; American Society for Gastrointestinal Endoscopy; Society of American Gastrointestinal and Endoscopic Surgeons. 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). Gastrointest Endosc. 2006 Jun;63(7):894-909. doi: 10.1016/j.gie.2006.03.918. No abstract available.

  PMID: 16733101 BACKGROUND

• Chiu HM, Lin JT, Wang HP, Lee YC, Wu MS. The impact of colon preparation timing on colonoscopic detection of colorectal neoplasms--a prospective endoscopist-blinded randomized trial. Am J Gastroenterol. 2006 Dec;101(12):2719-25. doi: 10.1111/j.1572-0241.2006.00868.x. Epub 2006 Oct 6.

  PMID: 17026559 BACKGROUND

• McNally PR, Maydonovitch CL, Wong RK. The effect of simethicone on colonic visibility after night-prior colonic lavage. A double-blind randomized study. J Clin Gastroenterol. 1989 Dec;11(6):650-2. doi: 10.1097/00004836-198912000-00010.

  PMID: 2584664 BACKGROUND

• McNally PR, Maydonovitch CL, Wong RK. The effectiveness of simethicone in improving visibility during colonoscopy: a double-blind randomized study. Gastrointest Endosc. 1988 May-Jun;34(3):255-8. doi: 10.1016/s0016-5107(88)71324-3.

  PMID: 3292345 BACKGROUND

• Wu L, Cao Y, Liao C, Huang J, Gao F. Systematic review and meta-analysis of randomized controlled trials of Simethicone for gastrointestinal endoscopic visibility. Scand J Gastroenterol. 2011 Feb;46(2):227-35. doi: 10.3109/00365521.2010.525714. Epub 2010 Oct 26.

  PMID: 20977386 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Simethicone; sodium sulfate

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Dimethylpolysiloxanes; Silicones; Siloxanes; Organosilicon Compounds; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Tercio Lopes, MD

  Iowa Digestive Disease Center

  PRINCIPAL INVESTIGATOR

• Silvio de Melo, MD

  University of Florida Health Systems, Jacksonville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2015
• First Posted: August 14, 2015
• Study Start: March 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: February 12, 2020

Record last verified: 2020-02

Locations

US (2)