Effect of Simethicone on Screening Colonoscopy

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

268 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-15

Study Completion Date

2019-04-10

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Adenoma Colon

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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Simethicone solution + Polyethylenglycol

This arm of the study will include the patients assigned to take simethicone solution with their colon preparations ( 4L Polyethyleneglycol)

Group Type EXPERIMENTAL

Simethicone Solution

Intervention Type DRUG

Patients will be assigned randomly to take Simethicone Solution plus polyethylenglycol

Polyethylenglycol

This arm of the study will include the patients assigned to take a regular bowel preparation (4L Polyethylenglycol)

Group Type ACTIVE_COMPARATOR

Polyethylenglycol

Intervention Type OTHER

Patients in this arm will be randomly assigned to take polyethylenglycol as their regular bowel preparation

Interventions

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Simethicone Solution

Patients will be assigned randomly to take Simethicone Solution plus polyethylenglycol

Intervention Type DRUG

Polyethylenglycol

Patients in this arm will be randomly assigned to take polyethylenglycol as their regular bowel preparation

Intervention Type OTHER

Other Intervention Names

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mylicon

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes