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Completed

NCT Number: NCT03119168

Effect of Simethicone on Screening Colonoscopy

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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Key information

Conditions

Adenoma Colon

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Texas Tech university Health Sciences Center El Paso

El Paso, Texas, 79905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Previous colonic surgery
  • Patient with mental/physical condition that impairs oral ingestion of preparation
  • Allergy or hypersensitivity to simethicone
  • Patients with limited mobility (bedridden patients)
  • Patients with gastrointestinal obstruction
  • Patients with gastroparesis

Treatment and study plan

Simethicone Solution

Drug

Patients will be assigned randomly to take Simethicone Solution plus polyethylenglycol

Other names: mylicon

Polyethylenglycol

Other

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

Primary outcomes

  1. Adenoma Detection Rate

    Time frame: 25 minutes

    The number of adenomatous polyps removed at colonoscopy

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Texas Tech University Health Sciences Center, El Paso

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 18, 2017
Registry last updated
Jun 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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