Effect of Simethicone on Screening Colonoscopy

Study Overview
=================
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 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.

Official 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

Conditions
-----------------
Adenoma Colon

Intervention / Treatment
-----------------
* Drug: Simethicone Solution
* Other: Polyethylenglycol


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Simethicone solution + Polyethylenglycol<br>This arm of the study will include the patients assigned to take simethicone solution with their colon preparations ( 4L Polyethyleneglycol) | Drug: Simethicone Solution<br>* Patients will be assigned randomly to take Simethicone Solution plus polyethylenglycol<br>* Other names: mylicon;|
| Active Comparator: Polyethylenglycol<br>This arm of the study will include the patients assigned to take a regular bowel preparation (4L Polyethylenglycol) | Other: Polyethylenglycol<br>* Patients in this arm will be randomly assigned to take polyethylenglycol as their regular bowel preparation<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
screening, adenoma detection rate, simethicone