Effect of Simethicone on Screening Colonoscopy

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

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.

Study Overview

• Status: Completed
• Conditions: Adenoma Colon
• Intervention / Treatment: Drug: Simethicone Solution; Other: Polyethylenglycol

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 Type: Interventional
• Enrollment (Actual): 268
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • El Paso, Texas, United States, 79905
      • Texas Tech University Health Sciences Center El Paso

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adenoma Detection Rate	The number of adenomatous polyps removed at colonoscopy	25 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Withdrawal Times	Amount spent withdrawing the scope during the colonoscopy	6-10 minutes
Colon Preparation	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.	25 minutes
Intraprocedural Use of Simethicone	The number of colonoscopies during which the endoscopist requested simethicone to be flushed through the endoscope.	6-10 minutes

Collaborators and Investigators

• Sponsor: Texas Tech University Health Sciences Center, El Paso
• Investigators: Principal Investigator: Antonio H Mendoza-Ladd, MD, Texas Tech University Health Sciences Center, El Paso

Publications and helpful links

General Publications

• Yoo IK, Jeen YT, Kang SH, Lee JH, Kim SH, Lee JM, Choi HS, Kim ES, Keum B, Chun HJ, Lee HS, Kim CD. Improving of bowel cleansing effect for polyethylene glycol with ascorbic acid using simethicone: A randomized controlled trial. Medicine (Baltimore). 2016 Jul;95(28):e4163. doi: 10.1097/MD.0000000000004163.
• Park JJ, Lee SK, Jang JY, Kim HJ, Kim NH. The effectiveness of simethicone in improving visibility during colonoscopy. Hepatogastroenterology. 2009 Sep-Oct;56(94-95):1321-5.
• Hassan C, Fuccio L, Bruno M, Pagano N, Spada C, Carrara S, Giordanino C, Rondonotti E, Curcio G, Dulbecco P, Fabbri C, Della Casa D, Maiero S, Simone A, Iacopini F, Feliciangeli G, Manes G, Rinaldi A, Zullo A, Rogai F, Repici A. A predictive model identifies patients most likely to have inadequate bowel preparation for colonoscopy. Clin Gastroenterol Hepatol. 2012 May;10(5):501-6. doi: 10.1016/j.cgh.2011.12.037. Epub 2012 Jan 10.
• Rex DK, Petrini JL, Baron TH, Chak A, Cohen J, Deal SE, Hoffman B, Jacobson BC, Mergener K, Petersen BT, Safdi MA, Faigel DO, Pike IM. Quality indicators for colonoscopy. Gastrointest Endosc. 2006 Apr;63(4 Suppl):S16-28. doi: 10.1016/j.gie.2006.02.021. No abstract available.
• Moraveji S, Casner N, Bashashati M, Garcia C, Dwivedi A, Zuckerman MJ, Carrion A, Ladd AM. The role of oral simethicone on the adenoma detection rate and other quality indicators of screening colonoscopy: a randomized, controlled, observer-blinded clinical trial. Gastrointest Endosc. 2019 Jul;90(1):141-149. doi: 10.1016/j.gie.2019.03.018. Epub 2019 Mar 26.

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2017
• Primary Completion (Actual): April 10, 2019
• Study Completion (Actual): April 10, 2019

Study Registration Dates

• First Submitted: April 10, 2017
• First Submitted That Met QC Criteria: April 13, 2017
• First Posted (Actual): April 18, 2017

Study Record Updates

• Last Update Posted (Actual): June 5, 2019
• Last Update Submitted That Met QC Criteria: June 3, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: adenoma detection rate; screening; simethicone
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Adenoma; Molecular Mechanisms of Pharmacological Action; Dermatologic Agents; Antifoaming Agents; Emollients; Simethicone
• Other Study ID Numbers: E17034

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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