Effect of Simethicone on Screening Colonoscopy

Texas Tech University Health Sciences Center, El Paso

Status and phase: Completed; Phase 4

Conditions: Adenoma Colon

Treatments: Other: Polyethylenglycol; Drug: Simethicone Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT03119168

E17034

Details and patient eligibility

About

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.

Full 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.

Enrollment: 268 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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268 participants in 2 patient groups

Simethicone solution + Polyethylenglycol

Experimental group

Description:

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

Treatment:

Drug: Simethicone Solution

Polyethylenglycol

Active Comparator group

Description:

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

Treatment:

Other: Polyethylenglycol