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OpenTrials
Completed

NCT Number: NCT02305251

Patient Preferences of a Resect and Discard Paradigm

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Washington University in St. Louis

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Survey

Other

Standard Gamble Survey

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Dec 2, 2014
Registry last updated
May 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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