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Patient Preferences of a Resect and Discard Paradigm

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ClinicalTrials.gov Identifier: NCT02305251
Recruitment Status : Completed
First Posted : December 2, 2014
Last Update Posted : May 11, 2017
Sponsor:
Information provided by (Responsible Party):
Dayna Early, Washington University School of Medicine

Brief Summary:
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.

Condition or disease Intervention/treatment
Colonic Polyps Other: Survey

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 500 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Patient Preferences of a Resect and Discard Paradigm
Study Start Date : June 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : November 2, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonic Polyps


Intervention Details:
  • Other: Survey
    Standard Gamble Survey


Primary Outcome Measures :
  1. Number of participants willing to pay out of pocket for pathology costs when a diminutive polyp is found. [ Time Frame: June, 2012 to March, 2014: up to 2 years ]
    This outcome is measured in percentage.


Secondary Outcome Measures :
  1. The factors that influence patients' decisions to pay or not pay for pathology costs with their own money. [ Time Frame: June, 2012 to March, 2014: up to 2 years ]
    These factors were measured using univariate analysis with generation of odds ratios and 95% confidence intervals.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients reporting in for colonoscopies either for screening or for polyp surveillance.
Criteria

Inclusion Criteria:

• Indication for colonoscopy is screening or routine polyp surveillance

Exclusion Criteria:

  • Indication for colonoscopy other than screening or surveillance
  • Colon cancer identified at time of colonoscopy
  • Known polyposis syndrome, or polyposis identified at colonoscopy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02305251


Locations
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United States, Missouri
Washington University in St. Louis
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Dayna S Early, MD Washington University School of Medicine
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dayna Early, Professor of Medicine, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02305251    
Other Study ID Numbers: 201202031
First Posted: December 2, 2014    Key Record Dates
Last Update Posted: May 11, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Colonic Polyps
Intestinal Polyps
Polyps
Pathological Conditions, Anatomical