Gastroenterology Services
Downers Grove, Illinois, 60515, United States
NCT Number: NCT01635725
The purpose of this investigation is validate a new bowel preparation scale and to compare it to existing bowel preparation scales.
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Notify Me18 year and older
All sexes
Observational
Downers Grove, Illinois, 60515, United States
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:
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:
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
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:
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: During a Colonoscopy (about 20 min)
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.
Gastroenterology Services, Ltd.
Other
New Bowel Preparation Scale for Measuring the Cleansing of the Colon for Colonoscopy
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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