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.

Study Overview

• Status: Completed
• Conditions: Colonic Polyps
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University in St. Louis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients reporting in for colonoscopies either for screening or for polyp surveillance.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	June, 2012 to March, 2014: up to 2 years

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Dayna S Early, MD, Washington University School of Medicine

Publications and helpful links

General Publications

• Rex DK. Narrow-band imaging without optical magnification for histologic analysis of colorectal polyps. Gastroenterology. 2009 Apr;136(4):1174-81. doi: 10.1053/j.gastro.2008.12.009. Epub 2008 Dec 10.
• Hassan C, Pickhardt PJ, Rex DK. A resect and discard strategy would improve cost-effectiveness of colorectal cancer screening. Clin Gastroenterol Hepatol. 2010 Oct;8(10):865-9, 869.e1-3. doi: 10.1016/j.cgh.2010.05.018. Epub 2010 Jun 1.
• Vu HT, Sayuk GS, Gupta N, Hollander T, Kim A, Early DS. Patient preferences of a resect and discard paradigm. Gastrointest Endosc. 2015 Aug;82(2):381-384.e1. doi: 10.1016/j.gie.2015.01.042. Epub 2015 Apr 22.

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): November 2, 2015

Study Registration Dates

• First Submitted: November 19, 2014
• First Submitted That Met QC Criteria: November 26, 2014
• First Posted (Estimate): December 2, 2014

Study Record Updates

• Last Update Posted (Actual): May 11, 2017
• Last Update Submitted That Met QC Criteria: May 10, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Polyps; Intestinal Polyps; Colonic Polyps
• Other Study ID Numbers: 201202031