An observational study in Colonic Polyps, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-05-11.
Sponsored by Washington University School of Medicine · Observational
The investigators conducted a study "Resect and Discard Diminutive Polyps: a new paradigm" (IRB ID # 201105473) from September, 2011 to July, 2013. This study examined whether doctors performing colonoscopy are accurate enough at predicting histology of small colorectal polyps, such that these small polyps could be resected and discarded (instead of being sent to pathology). One of the main advantages of this approach is significant cost savings by reducing pathology costs associated with screening and surveillance colonoscopy. A disadvantage is that there is a 0.03% chance that small polyps contain cancer. There is no data regarding patient preferences toward this approach. The investigators therefore designed a patient survey to determine the patient's view toward this approach.
The American Society of Gastrointestinal Endoscopy (ASGE) published a review article on a new paradigm in colorectal cancer screening termed "resect and discard". This new paradigm challenges the current practice of sending all colorectal polyps, regardless of appearance or size, to pathology for analysis. "Resect and Discard" describes a new approach in which small polyps could be removed, but be discarded instead of sent for pathology analysis. This is based on data showing that gastroenterologists can predict the pathology of small colorectal polyps with 80-90% accuracy, and that discarding small polyps would not alter surveillance recommendations.
Neither the ASGE document nor published research, however, assessed patient attitudes toward this approach. This study surveyed patients prior to first time screening colonoscopy, in order to determine their preferences about the resect and discard approach; specifically would patients be willing to pay for pathology analysis of small colorectal polyps with their own money, and what factors influence their decision. We also inquired about factors that would influence their decision to pay/not pay pathology costs themselves.
326 studies on the registry are indexed under Colonic Polyps; 53 are open to participants now.
This study's enrollment of 500 is close to the median of 500 across 94 observational studies indexed under Colonic Polyps.
Browse Colonic Polyps studies →Washington University School of Medicine is the lead sponsor of 1,795 studies on the registry; 271 are open to participants now.
Of its 330 completed or terminated interventional studies of FDA-regulated products, 216 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients reporting in for colonoscopies either for screening or for polyp surveillance.
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Exclusion Criteria:
Standard Gamble Survey
Number of participants willing to pay out of pocket for pathology costs when a diminutive polyp is found.
This outcome is measured in percentage.
Time frame: June, 2012 to March, 2014: up to 2 years
The factors that influence patients' decisions to pay or not pay for pathology costs with their own money.
These factors were measured using univariate analysis with generation of odds ratios and 95% confidence intervals.
Time frame: June, 2012 to March, 2014: up to 2 years
The record gives a start of Jun 2012, a primary completion of Mar 2014 and a completion of Nov 2015. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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