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

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ClinicalTrials.gov Identifier: NCT03410524
Recruitment Status : Completed
First Posted : January 25, 2018
Last Update Posted : December 12, 2018
Sponsor:
Collaborator:
Gastroenterology Consultants
Information provided by (Responsible Party):
Mohit Rishi, University of Nevada, Reno

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.


Condition or disease Intervention/treatment Phase
Colonoscopy Drug: Simethicone Solution Drug: Water Phase 3

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Endoscopist and patient blinded study.
Primary Purpose: Diagnostic
Official Title: Simethicone Pretreatment With Low-volume Polyethylene Glycol-3350 and Bisacodyl in an Effort to Improve Bowel Wall Visualization During Colonoscopy
Actual Study Start Date : January 9, 2018
Actual Primary Completion Date : October 31, 2018
Actual Study Completion Date : October 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arm Intervention/treatment
Active Comparator: 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.

Drug: Simethicone Solution
200 mg of Simethicone in 3 mL of Simethicone Solution Formulation

Placebo Comparator: 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.

Drug: Water
3 mL of water as placebo added to the bowel preparation




Primary Outcome Measures :
  1. Intraluminal Bubbles Scale [ Time Frame: Data reported during colonoscopy. ]
    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


Secondary Outcome Measures :
  1. Boston Bowel Preparation Scale [ Time Frame: Data reported during colonoscopy. ]
  2. Cecal insertion time [ Time Frame: Data reported during colonoscopy. ]
  3. Withdrawal time [ Time Frame: Data reported during colonoscopy. ]
  4. Number of polyp [ Time Frame: Data reported during colonoscopy. ]
  5. Type of polyp [ Time Frame: Post colonoscopy pathology. Up until pathology data reporting. Estimated up to 2 weeks after colonoscopy. ]
  6. Type of masses [ Time Frame: Post colonoscopy pathology. Up until pathology data reporting. Estimated up to 2 weeks after colonoscopy. ]
  7. Number of masses [ Time Frame: Data reported during colonoscopy. ]
  8. Adverse effects [ Time Frame: 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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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03410524


Locations
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United States, Nevada
Gastroenterology Consultants Reno - North Office and Endoscopy Center
Reno, Nevada, United States, 89502
Gastroenterology Consultants Reno - South Meadows Office and Endoscopy Center
Reno, Nevada, United States, 89521
Sponsors and Collaborators
University of Nevada, Reno
Gastroenterology Consultants
Investigators
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Principal Investigator: Eric Osgard, MD University of Nevada School of Medicine
Publications:

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Responsible Party: Mohit Rishi, Resident physician - Department of Internal Medicine, University of Nevada, Reno
ClinicalTrials.gov Identifier: NCT03410524    
Other Study ID Numbers: 1139179
First Posted: January 25, 2018    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Mohit Rishi, University of Nevada, Reno:
Bowel wall visualization
Intraluminal bubbles
Intraluminal foam
Simethicone
Additional relevant MeSH terms:
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Simethicone
Antifoaming Agents
Molecular Mechanisms of Pharmacological Action
Emollients
Dermatologic Agents