ColonoscopyNCT01635725
New Bowel Preparation Scale for Measuring Colon Cleanliness
An observational study of Colonoscopy and Bowel Cleanliness, run by Gastroenterology Services, Ltd. at 1 site in United States.
Trial summary
The purpose of this investigation is validate a new bowel preparation scale and to compare it to existing bowel preparation scales. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy, Bowel Cleanliness, Bowel Rating Scale
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Oct 2012
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients already planning to have a colonoscopy in our office endoscopy suite.
Who may be able to join
- All Patients undergoing a colonoscopy in our office endoscopy suite
Who cannot join
- Patients younger than 18 years old
Trial locations and contacts
1 site in 1 country.
United States1 site
Gastroenterology Services
Downers Grove, Illinois, 60515
About this study
Official title: New Bowel Preparation Scale for Measuring the Cleansing of the Colon for Colonoscopy
The purpose of this investigation is validate a new bowel preparation scale and to compare it to existing bowel preparation scales.
Read the detailed description
Early studies of bowel preparations for colonoscopy relied on scales to measure the cleanliness of the colon that were not validated or sensitive to differences in preparation quality. Often these scales would simply describe the bowel preparation as adequate or inadequate based on the endoscopist's judgment of quality of the overall preparation.
An ideal bowel cleanliness scale would:
- Produce a score that is reproducible from endoscopist to endoscopist (be validated).
- Be easy for the endoscopist to use.
- Produce a score that is easily converted into the poor/fair/good/excellent subjective rating scale that is often used by gastroenterologists in their colonoscopy reports.
- Produce a score that is easily converted into the adequate/inadequate subjective rating scale that is often used by gastroenterologists in their colonoscopy reports.
- Recognize truly outstanding preparations where 100% of the mucosa is well visualized without any cleaning required.
- Recognize adequate preparations (the ability to visualize the mucosa), but also measure the effort required to clean the colon of residual liquid.
In 2004, a study validating the Ottawa Preparation Scale (OPS) was published (Rostom, Jolicoeur, 2004). A description of the scoring system is below:
Ottawa Preparation Scale (OPS) rating for each colon segment 4=Inadequate (Solid stool not cleared with washing and suctioning) 3=Poor (Necessary to wash and suction to obtain a reasonable view) 2=Fair (Necessary to suction liquid to adequately view segment) 1=Good (Minimal turbid fluid in segment) 0=Excellent (Mucosal detail clearly visible) Ottawa Preparation Scale (OPS) rating for the amount of fluid in the whole colon 2=Lots of fluid
1=Moderate fluid 0=Little fluid
OPS is calculated by adding the ratings of the right, transverse/descending and sigmoid/rectum colon segments and the rating for the fluid in the whole colon. The overall OPS is reported from 14 (very poor) to 0 (excellent).
Although the OPS was a major improvement over previous cleanliness scales, there were a number of significant problems with the OPS:
- The segments rated were not easily defined by the endoscopist, especially the demarcation between the descending colon and the sigmoid colon.
- The segment scores were based on how much cleaning was required to view the mucosa of each segment, rather than the quality of the ultimate view of the mucosa. Although it is preferred to have a colon that does not require any cleaning, the ultimate view of the mucosa is what is most important.
- Adequate and inadequate preparations do not correlate with the OPS score. For example, if 2 segments were rated Excellent and one was rated Inadequate, then the total score would be 4 - but the colon cleansing would not be adequate for a good quality colonoscopy. If it were necessary to suction liquid from all 3 segments, then the total score would be 6 - but the colon cleansing still would be adequate and might even be excellent after cleaning.
- The OPS suffers from a poorly designed scoring system that is not easily converted into the poor/fair/good/excellent subjective rating scale which is often used by gastroenterologists in their colonoscopy reports.
- The OPS penalizes for liquid in the colon which does not necessarily correlate with a poorer quality view of the mucosa. Preparations given in split doses (half the night before and half the morning of the procedure) tend to be wetter because there is less time for the preparation to pass through the body. As long as the fluid is clear or easily suctioned through the colonoscopy, it does not negatively impact the ultimate of the view of the mucosa.
In 2009, a study validating the Boston Bowel Preparation Scale (BBPS) was published (Edwin, Calderwood, et al., 2009). A description of the scoring system is below:
Boston Bowel Preparation Scale (BBPS) rating for each colon segment 0=Unprepared colon segment with stool that cannot be cleared
- Portion of mucosa in segment seen after cleaning, but other areas not seen due to retained material
- Minor residual material after cleaning, but mucosa of segment generally well seen
- Entire mucosa of segment well seen after washing
BBPS is calculated by adding the ratings of the right, transverse and left colon segments. The overall BBPS is reported from 0 (very poor) to 9 (excellent).
The BBPS was simpler for the endoscopist use than the OPS, it rated the ultimate cleanliness of the colon rather than the effort required to clean the colon, and the segments of the colon the endoscopist rated were anatomically easier to define. Still, there were a number of significant problems with the BBPS:
- Adequate and inadequate preparations do not correlate with the BBPS score. For example, if the entire mucosa of 2 segments was well seen and one segment was Unprepared, then the score would be 6 - but the colon cleansing would not be adequate for a good quality colonoscopy. If it there was minor residual material after cleaning in all 3 segments, then the score would also be 6 - but the colon cleansing would be adequate for a good quality colonoscopy.
- The BBPS suffers from poorly a designed scoring system that is not easily converted into the poor/fair/good/excellent subjective rating scale that is often used by gastroenterologists in their colonoscopy reports.
- The BBPS does not penalize for liquid in the colon. While liquid that can be removed does not necessarily correlate with a poorer view of the mucosa, a preparation that cleans the colon well and leaves it dry would be preferred.
- A truly outstanding colon preparation would allow 100% of the mucosa to be viewed without any cleaning. The BBPS is not very sensitive to truly outstanding preparations since it does not penalize for the effort required to clean the colon.
- Segments of the colon which are rated 1 on the BBPS can vary greatly in cleanliness. For example, a colon where all 3 segments had 2% of the mucosa not well seen could receive a BBPS score of 3 and the preparation would be good to excellent. Another colon where each segment had 50% of the mucosa not well seen could receive a BBPS score of 3 and the preparation would be poor.
We propose to study a new bowel preparation scale that we call the "Chicago Bowel Preparation Scale" that overcomes most of the limitations of previous preparation scales.
- Conditions
- Colonoscopy, Bowel Cleanliness, Bowel Rating Scale
- Keywords
- colonoscopy, bowel cleanliness, bowel rating scale
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation coefficient between the PA and physician ratings of bowel cleanliness
The quality of the colon preparation will be graded based on the OPS, BBPS, an adequate/inadequate scale and our new CBPS. The correlation between the endoscopist's cleanliness rating and the physician assistant's cleanliness rating will be calculated using the appropriate statistical measures. These statistical measures were chosen before the study began by our statistical consultant.
Measured: During a Colonoscopy (about 20 min)
Secondary outcomes (1)
Correlation coefficient between the PA and physician ratings of total bowel fluid.
The amount of fluid present in the whole colon (excluding any fluid added to clean the mucosa) will be estimated by the physician's assistant and physician without discussing the estimate with each other. A covered suction bottle will be used to measure the actual volume of fluid suctioned. The correlation coefficient between the PA and physician ratings will be measured by statistics chosen before the study began by our statistical consultant.
Measured: During a Colonoscopy (about 20 min)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gastroenterology Services, Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David P Gerard, MD, Principal investigator, Gastroenterology Services, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01635725
- Sponsor's protocol ID
- AMH 2012-08
- Status last verified
- Mar 2017
- First submitted
- 4 Jul 2012
- Last updated
- 24 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Gerard DP, Foster DB, Raiser MW, Holden JL, Karrison TG. Validation of a new bowel preparation scale for measuring colon cleansing for colonoscopy: the chicago bowel preparation scale. Clin Transl Gastroenterol. 2013 Dec 5;4(12):e43. doi: 10.1038/ctg.2013.16.
PubMed 24304940
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Bowel Preparation Scale for Measuring the Cleansing of the Colon for Colonoscopy
- ClinicalTrials.gov ID
- NCT01635725
- Acronym / sponsor ID
- AMH 2012-08
- Conditions
- Colonoscopy, Bowel Cleanliness, Bowel Rating Scale
- Keywords
- colonoscopy, bowel cleanliness, bowel rating scale
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Gastroenterology Services, Ltd.University, hospital or other
- Study start
- Jul 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 10 Jul 2012 (estimated)
- 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.
The purpose of this investigation is validate a new bowel preparation scale and to compare it to existing bowel preparation scales.
Detailed description
Early studies of bowel preparations for colonoscopy relied on scales to measure the cleanliness of the colon that were not validated or sensitive to differences in preparation quality. Often these scales would simply describe the bowel preparation as adequate or inadequate based on the endoscopist's judgment of quality of the overall preparation.
An ideal bowel cleanliness scale would:
- Produce a score that is reproducible from endoscopist to endoscopist (be validated).
- Be easy for the endoscopist to use.
- Produce a score that is easily converted into the poor/fair/good/excellent subjective rating scale that is often used by gastroenterologists in their colonoscopy reports.
- Produce a score that is easily converted into the adequate/inadequate subjective rating scale that is often used by gastroenterologists in their colonoscopy reports.
- Recognize truly outstanding preparations where 100% of the mucosa is well visualized without any cleaning required.
- Recognize adequate preparations (the ability to visualize the mucosa), but also measure the effort required to clean the colon of residual liquid.
In 2004, a study validating the Ottawa Preparation Scale (OPS) was published (Rostom, Jolicoeur, 2004). A description of the scoring system is below:
Ottawa Preparation Scale (OPS) rating for each colon segment 4=Inadequate (Solid stool not cleared with washing and suctioning) 3=Poor (Necessary to wash and suction to obtain a reasonable view) 2=Fair (Necessary to suction liquid to adequately view segment) 1=Good (Minimal turbid fluid in segment) 0=Excellent (Mucosal detail clearly visible) Ottawa Preparation Scale (OPS) rating for the amount of fluid in the whole colon 2=Lots of fluid
1=Moderate fluid 0=Little fluid
OPS is calculated by adding the ratings of the right, transverse/descending and sigmoid/rectum colon segments and the rating for the fluid in the whole colon. The overall OPS is reported from 14 (very poor) to 0 (excellent).
Although the OPS was a major improvement over previous cleanliness scales, there were a number of significant problems with the OPS:
- The segments rated were not easily defined by the endoscopist, especially the demarcation between the descending colon and the sigmoid colon.
- The segment scores were based on how much cleaning was required to view the mucosa of each segment, rather than the quality of the ultimate view of the mucosa. Although it is preferred to have a colon that does not require any cleaning, the ultimate view of the mucosa is what is most important.
- Adequate and inadequate preparations do not correlate with the OPS score. For example, if 2 segments were rated Excellent and one was rated Inadequate, then the total score would be 4 - but the colon cleansing would not be adequate for a good quality colonoscopy. If it were necessary to suction liquid from all 3 segments, then the total score would be 6 - but the colon cleansing still would be adequate and might even be excellent after cleaning.
- The OPS suffers from a poorly designed scoring system that is not easily converted into the poor/fair/good/excellent subjective rating scale which is often used by gastroenterologists in their colonoscopy reports.
- The OPS penalizes for liquid in the colon which does not necessarily correlate with a poorer quality view of the mucosa. Preparations given in split doses (half the night before and half the morning of the procedure) tend to be wetter because there is less time for the preparation to pass through the body. As long as the fluid is clear or easily suctioned through the colonoscopy, it does not negatively impact the ultimate of the view of the mucosa.
In 2009, a study validating the Boston Bowel Preparation Scale (BBPS) was published (Edwin, Calderwood, et al., 2009). A description of the scoring system is below:
Boston Bowel Preparation Scale (BBPS) rating for each colon segment 0=Unprepared colon segment with stool that cannot be cleared
- Portion of mucosa in segment seen after cleaning, but other areas not seen due to retained material
- Minor residual material after cleaning, but mucosa of segment generally well seen
- Entire mucosa of segment well seen after washing
BBPS is calculated by adding the ratings of the right, transverse and left colon segments. The overall BBPS is reported from 0 (very poor) to 9 (excellent).
The BBPS was simpler for the endoscopist use than the OPS, it rated the ultimate cleanliness of the colon rather than the effort required to clean the colon, and the segments of the colon the endoscopist rated were anatomically easier to define. Still, there were a number of significant problems with the BBPS:
- Adequate and inadequate preparations do not correlate with the BBPS score. For example, if the entire mucosa of 2 segments was well seen and one segment was Unprepared, then the score would be 6 - but the colon cleansing would not be adequate for a good quality colonoscopy. If it there was minor residual material after cleaning in all 3 segments, then the score would also be 6 - but the colon cleansing would be adequate for a good quality colonoscopy.
- The BBPS suffers from poorly a designed scoring system that is not easily converted into the poor/fair/good/excellent subjective rating scale that is often used by gastroenterologists in their colonoscopy reports.
- The BBPS does not penalize for liquid in the colon. While liquid that can be removed does not necessarily correlate with a poorer view of the mucosa, a preparation that cleans the colon well and leaves it dry would be preferred.
- A truly outstanding colon preparation would allow 100% of the mucosa to be viewed without any cleaning. The BBPS is not very sensitive to truly outstanding preparations since it does not penalize for the effort required to clean the colon.
- Segments of the colon which are rated 1 on the BBPS can vary greatly in cleanliness. For example, a colon where all 3 segments had 2% of the mucosa not well seen could receive a BBPS score of 3 and the preparation would be good to excellent. Another colon where each segment had 50% of the mucosa not well seen could receive a BBPS score of 3 and the preparation would be poor.
We propose to study a new bowel preparation scale that we call the "Chicago Bowel Preparation Scale" that overcomes most of the limitations of previous preparation scales.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients already planning to have a colonoscopy in our office endoscopy suite.
Key inclusion criteria (1 listed)
- All Patients undergoing a colonoscopy in our office endoscopy suite
Key exclusion criteria (1 listed)
- Patients younger than 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation coefficient between the PA and physician ratings of bowel cleanliness
Time frame: During a Colonoscopy (about 20 min)
The quality of the colon preparation will be graded based on the OPS, BBPS, an adequate/inadequate scale and our new CBPS. The correlation between the endoscopist's cleanliness rating and the physician assistant's cleanliness rating will be calculated using the appropriate statistical measures. These statistical measures were chosen before the study began by our statistical consultant.
1 secondary outcome
Correlation coefficient between the PA and physician ratings of total bowel fluid.
Time frame: During a Colonoscopy (about 20 min)
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 24 Mar 2017.
- Results publication: PubMed 24304940Gerard DP, Foster DB, Raiser MW, Holden JL, Karrison TG. Validation of a new bowel preparation scale for measuring colon cleansing for colonoscopy: the chicago bowel preparation scale. Clin Transl Gastroenterol. 2013 Dec 5;4(12):e43. doi: 10.1038/ctg.2013.16.
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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.
David P Gerard, MD principal investigator
Gastroenterology Services, Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colonoscopy and Bowel Cleanliness, run by Gastroenterology Services, Ltd. at 1 site in United States.
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 24 Mar 2017. 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 United States. 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.
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?
Correlation coefficient between the PA and physician ratings of bowel cleanliness (time frame: During a Colonoscopy (about 20 min)). 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 NCT01635725, which also lists 1 linked publication.
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 24 Mar 2017; AzTrials last refreshed its copy on 30 Oct 2026.