Adenoma Colon
Conditions
Keywords
screening, adenoma detection rate, simethicone
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.
Interventions
Patients will be assigned randomly to take Simethicone Solution plus polyethylenglycol
OTHERPolyethylenglycol
Patients in this arm will be randomly assigned to take polyethylenglycol as their regular bowel preparation
Sponsors
Texas Tech University Health Sciences Center, El Paso
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adenoma Detection Rate | 25 minutes | The number of adenomatous polyps removed at colonoscopy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Withdrawal Times | 6-10 minutes | Amount spent withdrawing the scope during the colonoscopy |
| Colon Preparation | 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. |
| Intraprocedural Use of Simethicone | 6-10 minutes | The number of colonoscopies during which the endoscopist requested simethicone to be flushed through the endoscope. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Simethicone Solution + Polyethylenglycol This arm of the study will include the patients assigned to take simethicone solution with their colon preparations
Simethicone Solution: Patients will be assigned randomly to take Simethicone Solution plus polyethylenglycol | 129 |
| Polyethylenglycol This arm of the study will include the patients assigned to take a regular bowel preparation with Polyethylenglycol
Polyethylenglycol: Patients in this arm will be randomly assigned to take polyethylenglycol as their regular bowel preparation | 139 |
| Total | 268 |
Baseline characteristics
| Characteristic | Simethicone Solution + Polyethylenglycol | Polyethylenglycol | Total |
|---|---|---|---|
| Age, Continuous | 56.3 years STANDARD_DEVIATION 7.55 | 57 years STANDARD_DEVIATION 6.02 | 57 years STANDARD_DEVIATION 6.3 |
| Count of participants | 129 Participants | 139 Participants | 268 Participants |
| Race/Ethnicity, Customized Hispanic | 111 Participants | 124 Participants | 235 Participants |
| Race/Ethnicity, Customized Non Hispanic | 18 Participants | 15 Participants | 33 Participants |
| Region of Enrollment United States | 129 participants | 139 participants | 268 participants |
| Sex: Female, Male Female | 81 Participants | 92 Participants | 173 Participants |
| Sex: Female, Male Male | 48 Participants | 47 Participants | 95 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 129 | 0 / 139 |
| other Total, other adverse events | 0 / 129 | 0 / 139 |
| serious Total, serious adverse events | 0 / 129 | 0 / 139 |
Outcome results
Primary
Adenoma Detection Rate
The number of adenomatous polyps removed at colonoscopy
Time frame: 25 minutes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Simethicone Solution + Polyethylenglycol | Adenoma Detection Rate | 43 adenomas |
| Polyethylenglycol | Adenoma Detection Rate | 54 adenomas |
Secondary
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.
Time frame: 25 minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Simethicone Solution + Polyethylenglycol | Colon Preparation | Boston Bowel Preparation Scale | 8.9 score on a scale | Standard Deviation 0.4 |
| Simethicone Solution + Polyethylenglycol | Colon Preparation | Bubble Scale | 0.1 score on a scale | Standard Deviation 0.2 |
| Polyethylenglycol | Colon Preparation | Boston Bowel Preparation Scale | 8.9 score on a scale | Standard Deviation 0.4 |
| Polyethylenglycol | Colon Preparation | Bubble Scale | 2.1 score on a scale | Standard Deviation 2.1 |
Secondary
Intraprocedural Use of Simethicone
The number of colonoscopies during which the endoscopist requested simethicone to be flushed through the endoscope.
Time frame: 6-10 minutes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Simethicone Solution + Polyethylenglycol | Intraprocedural Use of Simethicone | 2 colonoscopies |
| Polyethylenglycol | Intraprocedural Use of Simethicone | 68 colonoscopies |
Secondary
Withdrawal Times
Amount spent withdrawing the scope during the colonoscopy
Time frame: 6-10 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Simethicone Solution + Polyethylenglycol | Withdrawal Times | 395.7 seconds | Standard Deviation 69.2 |
| Polyethylenglycol | Withdrawal Times | 399 seconds | Standard Deviation 76.7 |