Clinical Trial: Effect of Simethicone on Screening Colonoscopy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Effect of Simethicone on Bowel Preparation for Screening Colonoscopy.

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.

Detailed Summary: 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.
Sponsor: Texas Tech University Health Sciences Center, El Paso

Current Primary Outcome: Adenoma Detection Rate [ Time Frame: 25 minutes ]

The number of adenomatous polyps removed at colonoscopy


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Withdrawal times [ Time Frame: 6-10 minutes ]
    Amount spent withdrawing the scope during the colonoscopy
  • Colon preparation [ Time Frame: 25 minutes ]
    Quality of colon preparation based on standard scales


Original Secondary Outcome: Same as current

Information By: Texas Tech University Health Sciences Center, El Paso

Dates:
Date Received: April 10, 2017
Date Started: March 15, 2017
Date Completion: May 30, 2018
Last Updated: April 13, 2017
Last Verified: April 2017