ColonoscopyPhase 4NCT03157791
Simethicone and Bowel Preparation in Colonoscopy
A Phase 4 study testing Simethicone 180Mg Cap in people with Colonoscopy and Bowel Preparation, run by University of Manitoba at 1 site in Canada.
Trial summary
This Clinical Trial is being conducted to study the effect of oral simethicone on the presence of bubbles during colonoscopy. The purpose of this study is to find out what effects (good and bad) the addition of oral simethicone to bowel preparation has on the ability to visualize the colon mucosa (bowel) during… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy, Bowel Preparation
- What is being tested?
- Simethicone 180Mg Cap
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 471 participants
- Where
- 1 siteCanada
- Study dates
- 5 Jul 2017to 26 Nov 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients receiving colonoscopy who are within 30km of Brandon Manitoba and no other exclusion criteria
Who cannot join
- inability to provide informed consent, under 18 years old, inpatient, pregnancy, known hypersensitivity to simethicone, or excessive language barriers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Addition of Oral Simethicone to Bowel Preparation in Colonoscopy
This Clinical Trial is being conducted to study the effect of oral simethicone on the presence of bubbles during colonoscopy. The purpose of this study is to find out what effects (good and bad) the addition of oral simethicone to bowel preparation has on the ability to visualize the colon mucosa (bowel) during colonoscopy.
Read the 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.
- Conditions
- Colonoscopy, Bowel Preparation
- Being tested
- Simethicone 180Mg Cap
- Keywords
- simethicone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simethicone 180Mg CapDrug
Also called Gas-X
Simethicone Group A will take a total of 360mg prior to colonoscopy of Simethicone 180Mg Cap.
| Study group | Role | What they receive |
|---|---|---|
| Simethicone with Bowel Prep | Experimental | Group A will receive 2 simethicone tablets (180mg each) so that one tablet is taken at the same time as each bowel preparation dose. Receives: Drug: Simethicone 180Mg Cap |
| Control | No intervention | Group B will receive no simethicone tablets. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bubble Scale Score
The scale grades the amount of bubbles present in the colon from 0 (none) to 3 (severe)
Measured: Will be completed immediately after colonoscopy is completed
Secondary outcomes (1)
Ottawa Stool Scale
The scale grades the degree of bowel preparation from 0 (no preparation) to 3 (entire colon mucosa seen well)
Measured: Will be completed immediately after colonoscopy is completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start5 Jul 2017
- Primary completion26 Nov 2017
- Study completion26 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 471 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melissa Towle, RN, Study director, Brandon Regional Health CentreCharlenn Skead, BA, Study director, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03157791
- Sponsor's protocol ID
- B2017:056
- Status last verified
- May 2017
- First submitted
- 15 May 2017
- Last updated
- 23 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 7056467Martel 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.
PubMed 25863216Matro 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.
PubMed 23238113Parikh VA, Khanduja KS. Use of simethicone during colonoscopy. Dis Colon Rectum. 1995 Sep;38(9):1007-8. doi: 10.1007/BF02049743. No abstract available.
PubMed 7656734Ofstead 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.
PubMed 27497824
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addition of Oral Simethicone to Bowel Preparation in Colonoscopy
- ClinicalTrials.gov ID
- NCT03157791
- Acronym / sponsor ID
- B2017:056
- Conditions
- Colonoscopy, Bowel Preparation
- Keywords
- simethicone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 471 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 5 Jul 2017 (actual)
- Primary completion
- 26 Nov 2017 (actual)
- Study completion
- 26 Nov 2017 (actual)
- First posted
- 17 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Clinical Trial is being conducted to study the effect of oral simethicone on the presence of bubbles during colonoscopy. The purpose of this study is to find out what effects (good and bad) the addition of oral simethicone to bowel preparation has on the ability to visualize the colon mucosa (bowel) during colonoscopy.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simethicone with Bowel Prep | Experimental | Drug: Simethicone 180Mg CapGroup A will receive 2 simethicone tablets (180mg each) so that one tablet is taken at the same time as each bowel preparation dose. |
| Control | No intervention | –Group B will receive no simethicone tablets. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients receiving colonoscopy who are within 30km of Brandon Manitoba and no other exclusion criteria
Key exclusion criteria (1 listed)
- inability to provide informed consent, under 18 years old, inpatient, pregnancy, known hypersensitivity to simethicone, or excessive language barriers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simethicone 180Mg CapAlso: Gas-XSimethicone Group A will take a total of 360mg prior to colonoscopy of Simethicone 180Mg Cap. | Drug | Simethicone with Bowel Prep |
Primary outcome
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)
1 secondary outcome
Ottawa Stool Scale
Time frame: Will be completed immediately after colonoscopy is completed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2018.
- Background: PubMed 7056467Goldman 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.
- Background: PubMed 25863216Martel 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.
- Background: PubMed 23238113Matro 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.
- Background: PubMed 7656734Parikh VA, Khanduja KS. Use of simethicone during colonoscopy. Dis Colon Rectum. 1995 Sep;38(9):1007-8. doi: 10.1007/BF02049743. No abstract available.
- Background: PubMed 27497824Ofstead 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.
- Individual participant dataSharing planned: No
Related trials for Colonoscopy
Recruiting
Visual Aids for Colonoscopy Preparation: A Prospective Study on Patient Understanding and Bowel Cleanliness in Colonoscopy Patients
The Effect of Audio-visual Aids on Bowel Cleanliness, Audiovisual Aids
Recruiting
Artificial Intelligence to Implement Cost-saving Strategies for Colonoscopy Screening Based on in Vivo Prediction of Polyp Histology
Colonic Neoplasms
RecruitingObservational study
The French Gut-colo
Patients Aged 50-75 and Requiring Colonoscopy
Active, not recruiting
The PRIME-CRC Trial to Promote CRC Screening in Rural Communities
Colorectal Cancer
Not yet recruiting
Social Software-Based Intelligent Management System for Bowel Preparation
Colorectal Polyp, Colorectal Adenoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa Towle, RN study director
Brandon Regional Health Centre
Charlenn Skead, BA study director
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Simethicone 180Mg Cap in people with Colonoscopy and Bowel Preparation, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bubble Scale Score (time frame: Will be completed immediately after colonoscopy is completed). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03157791, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2018.