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Effect of Simethicone on Screening Colonoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03119168
Recruitment Status : Completed
First Posted : April 18, 2017
Results First Posted : June 5, 2019
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Antonio Mendoza-Ladd, Texas Tech University Health Sciences Center, El Paso

Study Description
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Brief Summary:
This study is evaluating the effect of adding a high dose of simethicone to the standard polyethylene glycol preparation for screening colonoscopy in the quality of the preparation , adenoma detection rate and withdrawal times.

Condition or disease Intervention/treatment Phase
Adenoma Colon Drug: Simethicone Solution Other: Polyethylenglycol Phase 4

Detailed Description:
A proper bowel preparation is key to a thorough and safe colonoscopy. Several factors affect the mucosal visualization during colonoscopy, and consequently the quality of such evaluation. Undoubtedly, this can have unfavorable implications like missed lesions. One of the most commonly encountered scenarios is the presence of multiple bubbles that interfere with mucosal visualization. When this occurs, simethicone (an antifoam agent used to reduce bloating when ingested orally) is injected through the colonoscope to eliminate the bubbles and get a clear view of the mucosa. A few studies have used oral simethicone in conjunction with oral preparation agents (PEG, magnesium citrate, sodium phosphate) in an attempt to improve the quality of the preparation. Unfortunately these studies have not used the exact same preparation agent with and without simethicone, making it difficult to draw conclusions on its efficacy. However, it is important to understand that simethicone is not intended to decrease the amount of stool in the colon, and it's purpose is to decrease the amount of bubbles interfering with the visualization of the mucosa provided that there is no stool present . Furthermore, it is unclear if adding simethicone to a standard bowel preparation makes a significant difference in key aspects of screening colonoscopy such as adenoma detection rate or withdrawal times. This prospective randomized controlled, observer blinded study at Texas Tech University Health Sciences Center in El Paso, aims at studying the effect of simethicone on the overall colon preparation as well as on adenoma detection rate and withdrawal times.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 268 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Screening
Official Title: The Effect Of Adding High Dose Simethicone To A Standard Polyethylene Glycol Preparation On Adenoma Detection Rate During Screening Colonoscopy: A Randomized Controlled Pilot Trial
Actual Study Start Date : March 15, 2017
Actual Primary Completion Date : April 10, 2019
Actual Study Completion Date : April 10, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
Drug Information available for: Simethicone

Arms and Interventions
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Arm Intervention/treatment
Experimental: Simethicone solution + Polyethylenglycol
This arm of the study will include the patients assigned to take simethicone solution with their colon preparations ( 4L Polyethyleneglycol)
 Drug: Simethicone Solution
Patients will be assigned randomly to take Simethicone Solution plus polyethylenglycol
Other Name: mylicon
Active Comparator: Polyethylenglycol
This arm of the study will include the patients assigned to take a regular bowel preparation (4L Polyethylenglycol)
 Other: Polyethylenglycol
Patients in this arm will be randomly assigned to take polyethylenglycol as their regular bowel preparation


Outcome Measures
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Primary Outcome Measures :
  1. Adenoma Detection Rate [ Time Frame: 25 minutes ]
    The number of adenomatous polyps removed at colonoscopy


Secondary Outcome Measures :
  1. Withdrawal Times [ Time Frame: 6-10 minutes ]
    Amount spent withdrawing the scope during the colonoscopy

  2. Colon Preparation [ Time Frame: 25 minutes ]

    Boston Bowel Preparation Scale (BBPS): scale that rates the quality of the colon preparation based on the amount of stool present. 0:solid stool that cannot be cleared; 1:areas not well seen due to residual stool and/or opaque liquid; 2:small fragments of stool and/or opaque liquid, but mucosa seen well; 3:no residual stool or opaque liquid seen. Score determined by adding the score of each individual segment of the colon (right side, transverse and left side). Scores range from 0 to 3 in each segment, therefore, a total composite score ranges from 0 (poor) to 9 (excellent).

    Bubble Score (BS): scale that rates the amount of bubbles present in the colon. 0:no or minimal bubbles; 1:bubbles covering up to half the luminal diameter; 2:bubbles covering the circumference of the lumen; 3:bubbles filling the entire lumen. Score determined the same way as BBPS score but in this case a total score of 0 is excellent and 9 is poor.


  3. Intraprocedural Use of Simethicone [ Time Frame: 6-10 minutes ]
    The number of colonoscopies during which the endoscopist requested simethicone to be flushed through the endoscope.


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Patients between the ages of 30-80 scheduled for screening colonoscopy.
  2. Male and female patients
  3. Ambulatory patients
  4. Signed informed consent form

Exclusion Criteria:

  1. Previous colonic surgery
  2. Patient with mental/physical condition that impairs oral ingestion of preparation
  3. Allergy or hypersensitivity to simethicone
  4. Patients with limited mobility (bedridden patients)
  5. Patients with gastrointestinal obstruction
  6. Patients with gastroparesis
Contacts and Locations
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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): NCT03119168


Locations
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United States, Texas
Texas Tech university Health Sciences Center El Paso
El Paso, Texas, United States, 79905
Sponsors and Collaborators
Texas Tech University Health Sciences Center, El Paso
Investigators
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Principal Investigator: Antonio H Mendoza-Ladd, MD Texas Tech University Health Sciences Center, El Paso
  Study Documents (Full-Text)

Documents provided by Antonio Mendoza-Ladd, Texas Tech University Health Sciences Center, El Paso:
Study Protocol and Statistical Analysis Plan  [PDF] January 10, 2018
Informed Consent Form  [PDF] August 2, 2018

More Information
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Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Antonio Mendoza-Ladd, Assistant Professor of Medicine, Texas Tech University Health Sciences Center, El Paso
ClinicalTrials.gov Identifier: NCT03119168    
Other Study ID Numbers: E17034
First Posted: April 18, 2017    Key Record Dates
Results First Posted: June 5, 2019
Last Update Posted: June 5, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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.: Yes
Keywords provided by Antonio Mendoza-Ladd, Texas Tech University Health Sciences Center, El Paso:
screening
adenoma detection rate
simethicone
Additional relevant MeSH terms:
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Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Simethicone
 Antifoaming Agents
Molecular Mechanisms of Pharmacological Action
Emollients
Dermatologic Agents