Conditions: Adenoma Colon
Keywords: screening adenoma detection rate simethicone
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 268
Healthy volunteers: yes

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.

Arms:
arm 1: This arm of the study will include the patients assigned to take simethicone solution with their colon preparations ( 4L Polyethyleneglycol) arm 2: This arm of the study will include the patients assigned to take a regular bowel preparation (4L Polyethylenglycol)

Interventions: intervention 1: Simethicone Solution intervention 2: Polyethylenglycol
Intervention descriptions: intervention 1: Patients will be assigned randomly to take Simethicone Solution plus polyethylenglycol intervention 2: Patients in this arm will be randomly assigned to take polyethylenglycol as their regular bowel preparation

Protocol document:
Prot_SAP_000.pdf: 
 
 
01/10/2018 
1 
 
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 
 
 
ABSTRACT 
Screening colonoscopy is a procedure that can effectively prevent colorectal cancer.  Adequate mucosal 
visualization is a critical aspect of this procedure and yet, several factors can interfere with it and 
consequently result in missed lesions.  One of the most commonly encountered factors affecting 
mucosal visualization is a poor preparation and/or the presence of multiple bubbles at the time of 
colonoscopy.  When a large amount of bubbles is found, simethicone (SIM) is commonly injected 
through the colonoscopy in order to eliminate them and get a better view of the mucosa.  However, this 
practice has been recently associated with outbreaks of multi-drug resistant bacterial infections, in 
several endoscopy centers. A few studies have used SIM in conjunction with colon preparation agents 
(CPA) such as polyethylene glycol (PEG), magnesium citrate, and sodium phosphate, in an attempt to 
improve the overall quality of the preparation.  Unfortunately, these studies have reported conflicting 
results due to a wide heterogeneity in their methodology and each study has used different CPAs and 
SIM doses.  Furthermore, with the exception of one recently published study from China, no study in 
western literature has reported an increase in adenoma detection rate (ADR) when SIM is added to a 
CPA.  Given this gap in knowledge, we are planning to conduct a pilot study to determine whether 
adding a high dose of SIM to a CPA results in a statistically significant difference in ADR.  
SPECIFIC AIMS 
The study’s primary aim is to establish if the ADR improves with the addition of high dose SIM 
suspension to a polyethylene glycol (PEG) preparation.  Secondary aims are to determine if this 
intervention results in shorter withdrawal times, better colon preparation, less intra procedure use of 
SIM and a higher polyp detection rate (PDR).  
BACKGROUND/SIGNIFICANCE 
An adequate bowel preparation is paramount for a screening colonoscopy.  Mucosal visualization can be 
dramatically affected by residual stool, bubbles, bile, intraluminal fluid or debris (1, 2).  Any of these 
features can ultimately lead to missed lesions, prolonged endoscopy duration, and decreased patient 
tolerance.  PEG is one of the most commonly used CPAs.  A few studies have reported that the addition 
of low to medium doses of SIM to lower volume PEG regimens (2L) or other CPAs such as sodium 
phosphate results in overall better colon preparations based on a standardized bubble scale (BS) and 
Boston preparation scales (BPS) (3-9).  Some of these studies have also reported a trend towards a 
higher number of polyps detected in the patients who added SIM to their CPA. This finding did not reach 
statistical significance likely due to the fact that they were neither powered enough nor primarily 
designed to do so.   


 
 
01/10/2018 
2 
 
It is important however, to understand that SIM is not a CPA.  It is and anti- foam medication and its 
purpose is to decrease the amount of bubbles interfering with visualization, provided that there is no 
stool present.  In clinical practice, it is very common to use it as a flush through the endoscope at the 
time of the procedure for that purpose.  Nevertheless, such use of SIM has been recently associated 
with the formation of biofilm inside the endoscope’s operative channels that is not eliminated by 
standard disinfecting and reprocessing techniques (10).   This biofilm leads to persistent moisture that 
has been noted as a contributing factor to outbreaks of multi-drug resistant microorganisms in a few 
high level endoscopy centers (11).    
In summary, previous studies have shown a trend towards a better overall preparation, and a higher 
polyp detection rate when a low to medium dose of SIM is added to a CPA. Therefore, the present pilot 
study is designed to determine if adding high dose SIM to a regular 4L PEG has the potential to positively 
impact the ADR, a benchmark quality indicator of screening colonoscopy.  Adding a high dose SIM to a 
CPA could not only result in a higher ADR, but also in a decrease use of SIM  through the endoscope at 
the time of the procedure, reducing the risk of possible life threatening infections for future patients. 
The intervention in this study although simple and inexpensive has the potential of making a significant 
impact in the health of our already underserved population. Our health sciences center is the only 
academic medical facility performing clinical and basic science research in southwest Texas and we serve 
a large number of patients, most of which are Hispanic Americans with only limited access to healthcare.  
RESEARCH PLAN 
Study Design:  
This is a single-center, prospective, randomized controlled, observer-blinded study of patients 
undergoing screening colonoscopy at a tertiary care medical facility.  
Primary endpoint 
To establish if the ADR improves with the addition of high dose SIM suspension to a 
polyethylene glycol (PEG) preparation  
Secondary endpoints 
1. Determine if adding a high dose of SIM to PEG reduces the withdrawal times during the 
screening colonoscopy. 
2. Determine if adding a high dose of SI to PEG results in an overall better colon preparation. 
3. Determine if adding a high dose of SIM to PEG results in less intra-procedural use of SIM. 
4. Determine if adding a high dose of SIM to PEG results in a higher polyp detection rate 
Inclusion criteria: 
1. Patients between the ages of 30-75 scheduled for screening colonoscopy. 
2. Male and female patients 


 
 
01/10/2018 
3 
 
3. Ambulatory patients 
4. Signed informed consent form 
5. Colonoscopy performed by an attending gastroenterologist 
6. The use of both Moderate Sedation and Monitored Anesthesia Care (MAC) sedation  
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 GI motility disorders( e.g. achalasia, gastroparesis, chronic constipation) 
7. Colonoscopy performed by GI fellows 
 
Patient Enrollment:  
Enrollment will be done prospectively until the desired number of patients is reached.  This study is 
planned as a parallel group randomized trial. One group of patients will be randomized to SIM plus PEG 
while the other group will be randomized to PEG only. The dose of SIM that will be used in this study is 
480 mg (2-times higher than the dose used in previous studies). The rationale for using a high dose is to 
maximize our outcome yield. Our proposed sample size is 300 patients. In our unit, we perform 
approximately 60 screening colonoscopies per week. We anticipate that approximately 10% of these 
patients will be eligible to participate in the study. Therefore, we expect to enroll the desired number of 
patients in approximately 24 months.  
Data Collection:  
 For each patient, the following data will be collected: 
1. Age (years) 
2. Gender (male/female) 
3. Ethnicity (Hispanics/non-Hispanics) 
4. Past medical and surgical history (yes/no) 
5. Bowel preparation quality (poor, fair, good, very good, excellent) 
6. Boston preparation scale score  
7. Bubble scale score 
8. Cecal intubation time (minutes and seconds) 
9. Withdrawal time (minutes and seconds) 
10.  Effective procedure time (minutes and seconds) 
11. Number and size of polyps detected 
12. Number of adenomas detected 


 
 
01/10/2018 
4 
 
13. Intra-procedure use of SIM  
Sample size calculation 
The dose of simethicone that will be used in this study is 480 mg (2-times higher than the dose used in 
previous studies).   The rationale for using a high dose is to maximize our outcome yield. Our sample size 
calculation was based on articles by Yoo et al 8, Jansen et al 9 and Bai et al10 using the following formula 
considering ADR as the primary outcome:  
 
Where p1 was the % of outcome in the intervention group and p2 the % of outcome in the control 
group.  Bai et al10 reported ADR of 21.0% in the PEG+SIM group and 14.3% in the PEG group. With these 
results, a sample size of 509 per group would be suitable for the parent study. For the pilot study, 10% 
of the calculated sample size for the parent study would be an acceptable estimation 13.  Considering the 
heterogeneity of the study by Bai et al, we decided to include 20% of the total calculated sample size in 
this pilot study. Therefore, 102 patients per group would be an appropriate sample size to compare ADR 
in this pilot study.  
Other outcomes to explore in the current study include preparation quality and PDR.  Yoo et al 8 
reported that 99% of patients receiving PEG+SIM had BPS scores of 6-9 compared to only 84% in the 
patients who received PEG.  Considering BPS scores as the outcome (p1=99% and q1=84%), with α=0.05 
and β=0.2, a total of 110 patients will be needed, 55 in each arm.  On the other hand, Jansen et al 9 
reported that PDR in patients who received PEG+SIM was 26.7% compared to 13.7% in those who 
received PEG.  With these results and following the same formula, a sample size of 150 patients per 
group will be needed to evaluate both bowel preparation and PDR.  Therefore, in order to have a 
sufficient study power and examine all parameters (ADR, PDR and bowel preparation quality), we 
decided to include 150 patients per group for a total of 300 patients.  
Statistical analysis 
1. Continuous data (e.g. effective procedure time, withdrawal time) will be described using mean 
and standard deviation (SD) or Median (Q1, Q3) based on D'Agostino-Pearson normality test in 
each group and will be compared with either independent t-test or nonparametric Mann-
Whitney.  Interval data (e.g. BPS, BS) will be presented as Median (Q1, Q3) in each group and 
compared with nonparametric Mann-Whitney. Categorical data (e.g. ADR) will be described 
using frequency and proportion (%) in each group and will be compared using Chi-square or 
Fisher's exact test where appropriate.  Further, number needed to treat (NNT) using SIM+PEG 
will be determined. Cohen's kappa coefficient will be used to measure inter-rater agreement 
between two endoscopists who will score BS and BPS.  In the eventual presence of baseline 
differences in cofactors, a relative risk regression developed by our biostatistician14 will be used 


 
 
01/10/2018 
5 
 
to determine adjusted effect of SIM+PEG compared to PEG alone on PDR and ADR. Other 
findings at colonoscopy 
 
All the statistical analyses will be performed using STATA 14 and p-values less than 5% will be considered 
significant results. All the statistical analyses will be performed by our Biostatistics and Epidemiology 
Consulting Lab (BECL) under the supervision of Dr. Dwivedi.  
METHODS 
Patients will be included in the study in a prospective manner at University Medical Center of El Paso 
endoscopy unit.  At the time of the pre-op appointment, the assessment nurse will provide all patients 
with routine instructions for colonoscopy including diet, hydration and fasting.  At the same 
appointment, the research coordinator, and/or an investigator will consent the patients and the 
research coordinator will randomize them using a random number list generated by a simple block 
randomization scheme by our study statistician, to one of two possible preparations: PEG+ SIM or PEG 
alone.  The randomization will be via sealed envelopes that will contain cards with the type of 
preparation to be used.  These coded envelopes will be randomly chosen by the patient.  Following 
randomization each patient will be assigned a code corresponding to one of the two preparation 
regimens.  This code will be noted and placed in a master spreadsheet that only the study coordinator 
and/or assigned research personnel will handle. The simethicone and instructions will be provided to 
the patients by the research coordinator. Patients randomized to PEG+SIM will drink 2L of PEG at 5 PM 
the evening before colonoscopy, and 2L 4hrs prior to the colonoscopy.  Patients in this group will be 
instructed to fill a standard 0.6 ml dropper with SIM suspension  (40 mg/0.6 ml) a total of   12 times and 
add it to  the gallon  of PEG solution. Patients assigned to PEG will drink the preparation in the exact 
same manner but without SIM.   
Prior to the procedure, a safety assessment of each patient will be completed which will include vital 
signs and a general examination. Patients will also complete a questionnaire evaluating compliance and 
side effects from the preparation.  This questionnaire will be administered and collected by an assigned 
research team member.  The patients will be instructed not to disclose any information regarding the 
preparation regimen to the endoscopist or any of the procedure nurses.  
Colonoscopies will be performed by 4 experienced endoscopists who will be blind to the type of 
preparation the patient received.  All procedures will be performed using Olympus 190 colonoscopes. 
During colonoscopy, standard parameters such as cecal intubation time, withdrawal time and number of 
polyps detected will be recorded.  For the purpose of this study, withdrawal time will be measured as 
follows: the timer will be started upon initiation of endoscope withdrawal once the cecum has been 
reached, and it will be paused every time the endoscopist needs to perform any maneuver or 
intervention such as polypectomy, biopsy, clip placement, hemostasis, suction for >5 seconds etc.  Once 
the endoscopist is done performing any of these, the timer will be re-started. Endoscopists will be free 
to ask for SIM during the procedure if he/she deems it necessary and the amount will be recorded by 
the research coordinator.  In addition, endoscopists will be asked to score the preparation according to 


 
 
01/10/2018 
6 
 
the standardized BS (0-3; 3 being the worst) and the BPS (3-0; 3 being the best) .  A total BPS score of >6 
and a BS of <2 will be considered adequate preparations.   
The BS that will be used in this study is the one previously used by Sudduth et al (7). This score grades 
different sections of the colon as follows: 0 = no or minimal, scattered bubbles believed not to be 
interfering with the examination; 1 = bubbles covering at least half the luminal diameter; 2 = bubbles 
covering the circumference of the lumen; 3 = bubbles filling the entire lumen.  The overall BS and BPS 
scores will be determined by adding the scores of each segment of the colon (rectosigmoid, transverse 
and ascending). For example, in a patient whose individual segment BS scores are as follows: 0,2,1; the 
final score is 3.  All endoscopists will be trained in the use of both scales prior to their participation in the 
study.  The bubble scale and the BPS scores will be independently determined by the endoscopist 
performing the procedure and by a second endoscopist who will review the still previously selected and 
labeled by the performing endoscopist and will assign his own score based on these images. Each 
endoscopist will be blind to the score provided by the other one and inter-observer agreement will be 
calculated.  
The ADR will be calculated once the pathology results of the polyps removed become available. 
INNOVATIONS 
To the best of our knowledge, this is the first study designed specifically to evaluate the effect of high 
dose of SIM in conjunction with 4 L PEG preparation on ADR in a western population.  Our pilot design 
will produce rapidly available data that will be then used to design a full sized trial that will definitively 
confirm or refute our hypothesis, which is that adding SIM to PEG improves ADR.   Our study is 
innovative in its methodology in the following aspects:  1. It is the first one to use a 4 L PEG preparation 
in both arms (previous studies have used 2 L PEG or other CPAs); 2. It is the first one performed in a 
standardized average risk western population undergoing screening colonoscopy (previous studies have 
included both screening and diagnostic colonoscopies); 3. It is a randomized controlled trial and its 
proposed methodology is a cost-effective approach compared to other alternatives; and 4. Inter-
observer agreement of both BPS and BS will be calculated, reducing the potential for bias. 
 
 
 
 
 
 
 
 


 
 
01/10/2018 
7 
 
REFERENCES 
1. Rex DK, Petrini JL, Baron TH, et al. Quality indicators for colonoscopy. Gastrointest Endosc. 
2006;63:S16-28. 
2. Hassan C, Fuccio L, Bruno M, et al. A predictive model identifies patients most likely to have 
inadequate bowel preparation for colonoscopy. Clin Gastroenterol Hepatol. 2012;10:501-506. 
3. Repici A, Cestari R, Annese V, et al. Randomised clinical trial: low-volume bowel preparation for  
colonoscopy - a comparison between two different PEG-based formulations. Aliment Pharmacol 
Ther 2012; 36: 717–724 
4. Valiante F, Bellumat A, De Bona M, et al.  Bisacodyl plus split 2-L polyethylene glycol-citrate-
simethicone improves quality of bowel preparation before screening colonoscopy. World J 
Gastroenterol 2013 September 7; 19(33): 5493-5499. 
5. Park JJ, Lee SK, Jang JY, et al. The effectiveness of simethicone improving visibility during 
colonoscopy. Hepato-Gastroenterology. 2009 56 1321-1325. 
6. Matro R, Tupchong K, Daskalakis C, et al.  The effect on colon Visualization during colonoscopy 
of the addition of simethicone to polyethylene glycol-electrolyte solution: a randomized single-
blind study. Clin Transl Gastroenterol. 2012 Nov; 3(11): e26 
7. Sudduth R, DeAngelis S, et al.  The effectiveness of simethicone in improving visibility during 
colonoscopy when given with a sodium phosphate solution: a double-blind randomized study. 
Gastrointest Endosc. 1995 Nov;42(5):413-5. 
8. Yoo IK, Jeen YT, Kang SH, et al. Improving of bowel cleansing effect for polyethylene glycol with 
ascorbic acid using simethicone: A randomized controlled trial. Medicine (Baltimore). 
2016;95:e4163 
9. Jansen SV, Goedhard JG, Winkens B et al. Preparation before colonoscopy: a randomized 
Controlled trial comparing different regimes. Eur J Gastroenterol Hepatol. 2011 Oct;23(10):897-
902.   
10. Ofstead CL, Wetzler HP, Johnson EA, et al. Simethicone residue remains inside gastrointestinal 
endoscopes despite reprocessing.  Am J Infect Control. 2016 Nov 1;44(11):1237-1240. 
11. US Senate. Senate Health, Education, Labor and Pensions Committee Minority Staff Report: 
Preventable Tragedies: Superbugs and How Ineffective Monitoring of Medical Device Safety Fails 
Patients. Patty Murray, Ranking Member Jan13, 2016 
http://www.help.senate.gov/imo/media/doc/Duodenoscope%20Investigation%20FINAL%20Rep
ort.pdf. [Accessed 22 Nov 2016]. A comprehensive summary of the issues related to 
duodenoscope-related outbreaks prepared for the Senate HELP Committee.Ofstead CL, Wetzler 
HP, Johnson EA, et al. Simethicone residue remains inside gastrointestinal endoscopes despite 
reprocessing.  Am J Infect Control. 2016 Nov 1;44(11):1237-1240. 
12. Ofstead CL, Wetzler HP, Johnson EA, et al. Simethicone residue remains inside gastrointestinal 
endoscopes despite reprocessing.  Am J Infect Control. 2016 Nov 1;44(11):1237-1240. 
13. Dwivedi AK, Mallawaarachchi I, Lee S et al. Methods for estimating relative risk in studies of 
common binary outcomes. J Appl Stat 2013;41(Aug 2014):484-500 
14. Francis DL, Rodriguez-Correa DT, Buchner A et al. Application of a conversion factor to estimate 
the adenoma detection rate from the polyp detection rate. Gastrointest Endosc. 2011 
Mar;73(3):493-7. 

ICF_001.pdf: 
Page 1 of 6 
                     version: 08/02/18 
 
This consent form is not valid without a TTUHSC EP IRB stamp in the lower left corner of each page. 
 
CONSENT TO TAKE PART IN A RESEARCH STUDY 
 
This is a research study for people who voluntarily choose to take part. Please take your time to make a 
decision, and discuss the study with your personal doctor, family and friends if you wish. 
 
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 
 
INVESTIGATOR(s):  
Antonio Mendoza Ladd, MD - Principal Investigator 
Marc Zuckerman, MD – Co-Investigator 
Mohammad Bashashati- Co-Investigator  
 
Sharareh Moraveji, MD -Co-Investigator 
Marco Bustamante, MD – Co-Investigator 
Cesar J. Garcia, MD – Co-Investigator 
Nancy Casner MS, CCRC - (study coordinator)  
 
CONTACT TELEPHONE NUMBERS:  
You may contact the investigator at this number: 915 521 7843 during normal business hours if you develop 
any of the conditions listed in Question #8 of this form or if you have any unexpected complications. 
 
INSTITUTION: University Medical Center El Paso, Texas Tech University Health Sciences Center El Paso 
 
1. 
Why is this study being done?  This study is being done in order to decide if adding simethicone to 
GoLYTELY (PEG-3350) the standard screening colon preparation decreases the amount of bubbles 
present in the colon at the time of colonoscopy, making it easier for the doctor to see any abnormalities 
in the lining of the colon. 
 
 
2. 
How many people will take part in this study?  Approximately 375 patients will be included in this 
study; approximately 150 patients are planned to be in each of the 2 groups. 
 
3. 
Why am I being asked to take part in this research study? You are being asked to be in this study 
because you are between the ages of 30-75 and are scheduled to have a screening colonoscopy.  
 
4. 
What will happen during this study? There will be 2 groups of patients.  One group will take 
simethicone along with the GoLYTELY and the other group will just take the GoLYTELY.   You will 
chose an envelope and be assigned to the group in a randomized manner, like flipping a coin, a 1:1 
ratio.  The doctor performing the colonoscopy will not know the group you are in. The results of the 
colonoscopies in both groups will be compared to decide if adding simethicone to the GoLYTELY made 
any difference in the amount of bubbles seen in your colon by the doctor performing the colonoscopy.  
 
5. 
What will be done that is different from my usual care? You may be asked to take a dose of 
simethicone with your colonoscopy preparation if you are assigned to that group. You will complete a 
brief questionnaire regarding your preparation before the colonoscopy. In addition to the usual 
information collected from the medical record: your age, gender, ethnicity, past medical and surgical 
history data relating to your colonoscopy finding will also be collected. 
 
 


Page 2 of 6 
                     version: 08/02/18 
 
6. 
How much of my time will this study take? How long will I be in the study? The only extra time that 
you will need to be in the study is about 5 minutes which is the time to answer the questionnaire.  
 
7. 
Are there any benefits to me if I take part in this study?  There is no guarantee that there will be any 
benefit. However, if the addition of simethicone improves the quality of the colonoscopy preparation you 
may benefit by having more polyps detected and/or removed by the doctor performing your 
colonoscopy, therefore decreasing you chances of getting colon cancer in the future.  
 
8. 
What are the risks and/or discomforts to me if I join this study? The risks of participating in this 
study are the same as those of getting a standard screening colonoscopy. These are a 1 in 10,000 chance 
of bleeding or having a tear in your colon that requires emergency surgery and the risks related to the 
sedation such as (breathing) problems or aspiration pneumonia (inhaling gastric contents into your 
lungs that can cause infection) Other risks are the possible such as allergic reactions to simethicone but 
these are unlikely since it is a standard medication that is used even in babies to prevent indigestion..  
 
GoLYTELY should be used with caution in patients with arrhythmias, seizures, chronic kidney disease 
or    reduced kidney function. If you suffer from one of these conditions notify the nurse and or the 
doctor. 
 
There may be other risks that are unknown. 
 
9. 
Will there be any added risks to me from this study if I am a female? No  
 
10. 
What other choices do I have if I do not take part in the research study? This study does not involve 
treatment. You do not have to take part in this study. 
  
11. 
What about confidentiality and the privacy of my records?  
We will keep your involvement in this research study confidential to the extent permitted by law. In 
addition to the staff carrying out this study, others may learn that you are in the study. This might 
include federal regulatory agencies such as the Food and Drug Administration (FDA) and the Office for 
Human Research Protection (OHRP), Texas Tech University Health Sciences Center El Paso (TTUHSC 
El Paso) representatives, representatives from any hospital or site where the research takes place, and 
the TTUHSC El Paso Institutional Review Board (a committee that reviews and approves research). 
These people may review and copy records involving your participation in this research. A copy of this 
document may be placed in your medical record.  
 
The results of the study that are used in publications or abstracts will not include your name.    
 
 
12. 
Who is funding this study? The department of Medicine at Texas Tech University Health Sciences 
Center El Paso is providing the space and supplies for this study. No one on the research staff will 
receive anything of value from other agencies, organizations, or companies to carry out this research.  
 
 
 
13. 
Will it cost me anything to take part in this research study? No.  If you are selected to take 
simethicone, we will provide it to you at no cost.  The cost of the procedure is already being paid by 
either yourself or your insurance company. 
  
14. 
Will I receive anything for taking part in this research study? No  
 
15. 
Does anyone on the research staff have a personal financial interest in this study? No  
 


Page 3 of 6 
                     version: 08/02/18 
 
16. 
What if I am hurt by participating in this study? 
 
Texas Tech University Health Sciences Center El Paso and University Medical Center El Paso do not 
offer to pay for or cover the cost of medical treatment for research related illness or injury. No funds 
have been set aside to pay or reimburse you in the event of such injury or illness unless specifically 
stated.  
 
 
If you have a research related illness or injury, care will be available to you as usual, but you and/or 
your medical or hospital insurance company will be responsible for the cost of treatment. Before 
entering this study, you should check whether your insurance company might limit your insurance 
coverage if you take part in a research study.  
 
17. 
What are my rights as a voluntary participant? 
Taking part in this study is your choice. If you sign this form, it means that you choose to be in the study.  
 
You may also choose not to be in this study. If you decide not to be in the study, it will not affect any 
medical care, benefits or rights to which you are entitled. 
 
If new information becomes available during the study that may affect your willingness to take part in 
the study, you will be told. 
 
18. 
Can I stop being in the study? 
You may leave the study at any time. If you leave the study, we cannot remove any information we have 
collected to that point. 
 
19. 
Can someone else end my participation in the study? 
Under certain circumstances, the investigators, TTUHSC El Paso, or the study sponsor may decide to 
end your participation in this research study earlier than planned. This might happen because of 
unexpected events in the study. 
 
20. 
What if I have questions? 
For questions about this study, contact the Antonio Mendoza Ladd, MD the Principal Investigator, at 
915 521 7843   
 
If you would like to speak to someone who is not involved in the study about your rights as a participant, 
research-related injuries, or any other matter related to the study, you can call the TTUHSC EthicsPoint 
Hotline at 1-866-294-9352. 
 
Or, you can file an EthicsPoint report online: 
https://secure.ethicspoint.com/domain/media/en/gui/44534/index.html. Please choose the “Regulatory 
Compliance” option when making an online report. 
 
A description of this clinical trial will be available on www.ClinicalTrials.gov, as required by U.S. 
Law. This Web site will not include information that can identify you. At most the Web site will include a 
summary of the results. You can search this Web site at any time. 
 
 
 
 
 
 
 


Page 4 of 6 
                     version: 08/02/18 
 
Your signature indicates that: 
 this research study has been explained to you; 
 you have been given the opportunity to ask questions and have received answers; 
 you accept your responsibility to follow the instructions given to you by the research team 
regarding study participation and, if applicable, research medication; 
 you agree to take part in this study. 
 
You will be given a signed copy of this form. 
 
 
 
Printed Name of Subject 
 
 
 
 
 
AM/PM 
Signature of Subject 
Date 
 
 
 
Time  
 
 
I have discussed this research study with the subject using language that is understandable and appropriate. I 
believe I have fully informed the subject of the possible risks and benefits, and I believe the subject understands 
this explanation. I have given a copy of this form to the subject.  
 
 
 
 
 
Printed name of authorized research personnel who 
conducted the informed consent discussion 
 
 
 
 
 
AM/PM 
Signature of authorized research personnel who 
Date 
 
 
 
Time 
conducted the informed consent discussion 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Page 5 of 6 
                     version: 08/02/18 
 
TEXAS TECH UNIVERSITY HEALTH SCIENCES CENTER EL PASO 
AUTHORIZATION TO USE AND/OR DISCLOSE YOUR PROTECTED HEALTH INFORMATION 
for a RESEARCH STUDY 
 
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 
 
This form is intended to tell you about the use and/or disclosure (sharing) of your personal Protected Health 
Information (PHI) if you decide to participate in the research study described on the previous pages. The health 
information about you that may be used or disclosed is described below. This information is usually found in 
your medical records. Only the health information about you that is needed for this research study will be used 
or disclosed. When you consider taking part in this research study, you are also being asked to give your 
permission for your Protected Health Information to be released from your doctors, clinics, and hospitals to the 
research personnel approved for this research study. This Authorization specifically relates to the research study 
described in the attached Informed Consent document. 
 
1. This Authorization is valid indefinitely or until such time as legal requirements will allow this Authorization 
to be destroyed. 
 
2. If you choose to cancel this Authorization, please give notice in writing to: 
 
TTUHSC El Paso Privacy Officer  
Office of Institutional Compliance  
5001 El Paso Drive 
El Paso, TX 79905 
 
If you sign this Authorization, the following persons, groups or organizations may rely on this Authorization to 
disclose your Protected Health Information to the Principal Investigator and other research personnel who are 
conducting this Study:  
 
• 
your treating physicians and healthcare providers and their staff, 
• 
associated healthcare institutions and hospitals where you have or may receive care. 
 
While this research study is in progress, the Principal Investigator or research personnel working on this study 
will inform you whether or not you will be allowed to see the research related health information that is created 
about you or collected by the research personnel prior to the end of the study. After the study is finished you 
may request this information as allowed by the TTUHSC El Paso Notice of Privacy Practices. 
The Protected Health Information that you authorize to be used or disclosed for research purposes may include 
your current or future health information from some or all of your health records, including:  
 
• 
hospital records and reports 
• 
admission history, and physical examination 
• 
X-ray films and reports; operative reports 
• 
laboratory reports, treatment and test results (including 
sexually transmitted diseases, HIV or AIDS) 
• 
any other Protected Health Information needed by the 
research personnel listed above. 
 
(* use separate form for disclosure of psychotherapy notes) 
• 
immunizations 
• 
allergy reports 
• 
prescriptions 
• 
consultations 
• 
clinic notes 
• 
mental health records 
• 
alcohol/substance abuse records 
 


Page 6 of 6 
                     version: 08/02/18 
 
 
For the purposes of this study, your Protected Health Information may need to be reviewed or disclosed to 
individuals or organizations within and/or outside of TTUHSC El Paso who sponsor, approve, assist with, 
monitor or oversee the conduct of research studies. This includes, but is not limited to, the TTUHSC El Paso 
Institutional Review Board, TTUHSC El Paso compliance reviews, the U.S. Food and Drug Administration 
(FDA) or governmental agencies in other countries. Some of these individuals or organizations may share your 
health information further, and your health information may not be protected by the same privacy standards that 
TTUHSC El Paso is required to meet. 
 
If you choose to sign this Authorization form, you can change your mind about this later. If you change your 
mind, send a letter to the person identified above telling us to stop collecting and sharing your Protected Health 
Information. When we receive your request, you may be asked to leave the research study if all the necessary 
information has not been collected. We may still use the information about you that we have already collected. 
We need to know what happens to everyone who starts a research study, not just those people who stay in it. 
 
You have the right to refuse to sign this form. If you choose not to sign this form, your 
regular health care will not be affected. However, not signing this form will prevent you 
from participating in this research study and prevent you from receiving research related 
health care services provided under this study. 
 
I have had the opportunity to review and ask questions regarding this Authorization to use or disclose my 
personal health information, and I will receive a copy of this form. By signing this Authorization, I am 
confirming that it reflects my wishes. 
 
 
 
 
Printed Name of Subject 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Signature of Subject 
Date