- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03157791
Simethicone and Bowel Preparation in Colonoscopy
Addition of Oral Simethicone to Bowel Preparation in Colonoscopy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Evaluation of the lower gastrointestinal (GI) tract by colonoscopy is now considered the gold standard and its use is on the rise in all GI units. Clean bowel preparation is a mandatory part of the procedure in order to visualize the bowel mucosa to determine pathology and provide therapeutic intervention safely if needed.
Colon lavage preparations have been effective in improving visibility of the colon and are well tolerated. Split dose bowel preparation regimens have been developed and adapted in order to optimize patient comfort and provide adequate cleanliness .
These bowel preparations address issues regarding the feculent residual material, however bubbles lining the mucosa remain a problem in attempting to visualize the colon mucosa. About 30% of adequately prepared bowels are now affected with mucosa lined with bubbles . The bubbles limit evaluation of the entire bowel, requiring more time to clean the bowel and possibly missing pathology such as small, flat sessile, serrated polyps, small apthous ulcers for crohns and many other pathologies.
Simethicone is a mixture of polydimethylsiloxane and hydrated silica gel and works by reducing surface tension of air bubbles, allowing small bubbles to coalesce to form larger bubbles allowing the air to pass as belching or flatulence. This makes simethicone an ideal antifoaming agent that has been used in all age groups to reduce bloating, abdominal discomfort, and abdominal pain.
In the past, use of simethicone in the irritant fluid has been used to wash away the bubbles, however there has been recent concern with scope manufacturers advising that simethicone not to be used routinely because of simethicone settling in the irrigation channel. This causes a concerning biofilm in the endoscope.
Use of oral simethicone instead of liquid simethicone through the endoscope as an adjuvant to the bowel preparation to reduce bubbles/foam has not been adopted widely due to lack of knowledge and literature available and the project's ability to secure funding. This project aims to compare the amount of bubbles and colon mucosa visibility between patients who ingested oral simethicone with bowel preparation and those who did not to evaluate the use of oral simethicone in future colonoscopies.
All patients who are referred to undergo colonoscopy are booked centrally in the GI Unit at the Brandon Regional Health Centre (BRHC) and are given instructions regarding bowel preparation and procedure time by the booking department. All patients including those not involved in research are instructed and scheduled in the same manner.
About a month prior to procedure all patients are sent bowel preparation instructions, procedure time and colonoscopy information. A letter explaining the study and requesting participation will be included with this information.
All patients are instructed to call the GI Unit 5 days prior to their procedure to confirm. At this time patients will be asked to participate in the study by the Clinical Resource Nurse (CRN) or CRN delegate.
Treatment group is determined by the number on each consent form. This number will be referenced with the master list to determine if the patient is in Group A or Group B. Participants will all be advised to not speak to the endoscopist about whether they have taken simethicone tablets or not. If participants were allotted to group A but present on the day of the procedure without having taking simethicone they will be excluded from the study.
On the day patients present to the GI unit for their colonoscopy they will undergo the same process as a participant not in the study. Participants will present to the interview desk. The patient will be reminded to not tell any physician or nurse other than the interview nurse. The interviewing nurse will ask the patient if they ingested the simethicone and if so what dosage and what brand of tablets. This will be noted on the simethicone ingestion form that will be placed in an envelope and in the appropriate folder in accordance with the treatment group to which the participant belongs. The interviewing nurse will then proceed with the regular intake form.
The endoscopy room will have the Boston Bowel Preparation Scale and the Bubble Scale labeled with appropriate participant number. The endoscopist will complete these forms once the procedure is finished and will be blinded as to which group the patient belongs. Once completed by the endoscopy nurse a photocopy of the Endoscopy Room Quality Indicators form will be placed with the participant folder with the identifying information blacked out and replaced with the participant number. All the completed forms will be collated and placed in a sealed envelope by the recovery room nurse and placed in the appropriate folder in accordance with the treatment group to which the participant belongs.
The amount of bubbles will be compared between Group A (simethicone) and Group B (no simethicone) using a chi square analysis with a statistical significance value of p=0.5. The same will be done for bowel cleanliness using the Ottawa stool scale.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Manitoba
-
Brandon, Manitoba, Canada, r7a2b3
- Brandon Regional Health Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients receiving colonoscopy who are within 30km of Brandon Manitoba and no other exclusion criteria
Exclusion Criteria:
- inability to provide informed consent, under 18 years old, inpatient, pregnancy, known hypersensitivity to simethicone, or excessive language barriers.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Simethicone with Bowel Prep
Group A will receive 2 simethicone tablets (180mg each) so that one tablet is taken at the same time as each bowel preparation dose.
|
Simethicone Group A will take a total of 360mg prior to colonoscopy of Simethicone 180Mg Cap.
Other Names:
|
No Intervention: Control
Group B will receive no simethicone tablets.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bubble Scale Score
Time Frame: Will be completed immediately after colonoscopy is completed
|
The scale grades the amount of bubbles present in the colon from 0 (none) to 3 (severe)
|
Will be completed immediately after colonoscopy is completed
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ottawa Stool Scale
Time Frame: Will be completed immediately after colonoscopy is completed
|
The scale grades the degree of bowel preparation from 0 (no preparation) to 3 (entire colon mucosa seen well)
|
Will be completed immediately after colonoscopy is completed
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Melissa Towle, RN, Brandon Regional Health Centre
- Study Director: Charlenn Skead, BA, University of Manitoba
Publications and helpful links
General Publications
- Goldman J, Reichelderfer M. Evaluation of rapid colonoscopy preparation using a new gut lavage solution. Gastrointest Endosc. 1982 Feb;28(1):9-11. doi: 10.1016/s0016-5107(82)72956-6.
- Martel M, Barkun AN, Menard C, Restellini S, Kherad O, Vanasse A. Split-Dose Preparations Are Superior to Day-Before Bowel Cleansing Regimens: A Meta-analysis. Gastroenterology. 2015 Jul;149(1):79-88. doi: 10.1053/j.gastro.2015.04.004. Epub 2015 Apr 8.
- Matro R, Tupchong K, Daskalakis C, Gordon V, Katz L, Kastenberg D. 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 29;3(11):e26. doi: 10.1038/ctg.2012.16.
- Parikh VA, Khanduja KS. Use of simethicone during colonoscopy. Dis Colon Rectum. 1995 Sep;38(9):1007-8. doi: 10.1007/BF02049743. No abstract available.
- Ofstead CL, Wetzler HP, Johnson EA, Heymann OL, Maust TJ, Shaw MJ. Simethicone residue remains inside gastrointestinal endoscopes despite reprocessing. Am J Infect Control. 2016 Nov 1;44(11):1237-1240. doi: 10.1016/j.ajic.2016.05.016. Epub 2016 Aug 3.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- B2017:056
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Colonoscopy
-
Borland-Groover ClinicValley Medical Products, LLC is paying for the study and is the sponsor....CompletedColonoscopy | Screening Colonoscopy | Surveillance ColonoscopyUnited States
-
Josue AliagaCompleted
-
Endostart srlCompleted
-
Rambam Health Care CampusUnknownInadequate Preparation for Colonoscopy; Personalized Colonoscopy PreparationIsrael
-
Hospital Central Norte PEMEXRecruitingPerformance of Colonoscopy | Tolerance of ColonoscopyMexico
-
VA Office of Research and DevelopmentVA Palo Alto Health Care System; VA Northern California Health Care SystemCompletedWater Exchange Colonoscopy | Unsedated Colonoscopy | Cap | Colonoscopy PainUnited States
-
Dalin Tzu Chi General HospitalCompletedColonoscopy | Intubation Time | Cap-assisted ColonoscopyTaiwan
-
Valduce HospitalCompletedUnsedated Colonoscopy | Warm Water | CO2 ColonoscopyItaly
-
Kartal Kosuyolu Yuksek Ihtisas Education and Research...UnknownColonoscopy | Complete Colonoscopy | Cecum Intubation Time | İleum Intubation TimeTurkey
-
Daewoong Pharmaceutical Co. LTD.Not yet recruiting
Clinical Trials on Simethicone 180Mg Cap
-
Lawson Health Research InstituteCompleted
-
Changhai HospitalUnknown
-
Affiliated Hospital to Academy of Military Medical...Completed
-
Asan Medical CenterGE HealthcareCompletedColorectal NeoplasmsKorea, Republic of
-
3MEurotrials Brasil Consultores Cientificos LtdaCompleted
-
Medical University of South CarolinaCompletedMedication AdherenceUnited States
-
BeBetter Med IncCompleted
-
Chiang Mai UniversityCompletedSterility, PostpartumThailand
-
The Affiliated Hospital of Qingdao UniversityRecruiting
-
Changhai HospitalTongji Hospital; Qilu Hospital of Shandong University; First Affiliated Hospital... and other collaboratorsCompletedAdenoma Detection Rate | Bowel Preparation Scale | the Amount of Air BubbleChina