Ignite Creation Date:
2024-05-06 @ 12:41 AM
Last Modification Date:
2024-10-26 @ 10:53 AM
Study NCT ID:
NCT01635725
Status:
COMPLETED
Last Update Posted:
2017-03-24
First Post:
2012-07-04
Brief Title:
New Bowel Preparation Scale for Measuring Colon Cleanliness
Sponsor:
Gastroenterology Services Ltd
Organization:
Gastroenterology Services Ltd
Study Overview
Official Title:
New Bowel Preparation Scale for Measuring the Cleansing of the Colon for Colonoscopy
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 endoscopists judgment of quality of the overall preparation
An ideal bowel cleanliness scale would
1 Produce a score that is reproducible from endoscopist to endoscopist be validated
2 Be easy for the endoscopist to use
3 Produce a score that is easily converted into the poorfairgoodexcellent subjective rating scale that is often used by gastroenterologists in their colonoscopy reports
4 Produce a score that is easily converted into the adequateinadequate subjective rating scale that is often used by gastroenterologists in their colonoscopy reports
5 Recognize truly outstanding preparations where 100 of the mucosa is well visualized without any cleaning required
6 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 4Inadequate Solid stool not cleared with washing and suctioning 3Poor Necessary to wash and suction to obtain a reasonable view 2Fair Necessary to suction liquid to adequately view segment 1Good Minimal turbid fluid in segment 0Excellent Mucosal detail clearly visible Ottawa Preparation Scale OPS rating for the amount of fluid in the whole colon 2Lots of fluid
1Moderate fluid 0Little fluid
OPS is calculated by adding the ratings of the right transversedescending and sigmoidrectum 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
1 The segments rated were not easily defined by the endoscopist especially the demarcation between the descending colon and the sigmoid colon
2 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
3 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
4 The OPS suffers from a poorly designed scoring system that is not easily converted into the poorfairgoodexcellent subjective rating scale which is often used by gastroenterologists in their colonoscopy reports
5 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 0Unprepared colon segment with stool that cannot be cleared
1 Portion of mucosa in segment seen after cleaning but other areas not seen due to retained material
2 Minor residual material after cleaning but mucosa of segment generally well seen
3 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
1 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
2 The BBPS suffers from poorly a designed scoring system that is not easily converted into the poorfairgoodexcellent subjective rating scale that is often used by gastroenterologists in their colonoscopy reports
3 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
4 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
5 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
An ideal bowel cleanliness scale would
1 Produce a score that is reproducible from endoscopist to endoscopist be validated
2 Be easy for the endoscopist to use
3 Produce a score that is easily converted into the poorfairgoodexcellent subjective rating scale that is often used by gastroenterologists in their colonoscopy reports
4 Produce a score that is easily converted into the adequateinadequate subjective rating scale that is often used by gastroenterologists in their colonoscopy reports
5 Recognize truly outstanding preparations where 100 of the mucosa is well visualized without any cleaning required
6 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 4Inadequate Solid stool not cleared with washing and suctioning 3Poor Necessary to wash and suction to obtain a reasonable view 2Fair Necessary to suction liquid to adequately view segment 1Good Minimal turbid fluid in segment 0Excellent Mucosal detail clearly visible Ottawa Preparation Scale OPS rating for the amount of fluid in the whole colon 2Lots of fluid
1Moderate fluid 0Little fluid
OPS is calculated by adding the ratings of the right transversedescending and sigmoidrectum 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
1 The segments rated were not easily defined by the endoscopist especially the demarcation between the descending colon and the sigmoid colon
2 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
3 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
4 The OPS suffers from a poorly designed scoring system that is not easily converted into the poorfairgoodexcellent subjective rating scale which is often used by gastroenterologists in their colonoscopy reports
5 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 0Unprepared colon segment with stool that cannot be cleared
1 Portion of mucosa in segment seen after cleaning but other areas not seen due to retained material
2 Minor residual material after cleaning but mucosa of segment generally well seen
3 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
1 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
2 The BBPS suffers from poorly a designed scoring system that is not easily converted into the poorfairgoodexcellent subjective rating scale that is often used by gastroenterologists in their colonoscopy reports
3 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
4 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
5 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None