Patient Preferences of a Resect and Discard Paradigm

Colonic Polyps Clinical Trial

Official title:

Patient Preferences of a Resect and Discard Paradigm

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02305251
• Other study ID #: 201202031
• Status: Completed
• Phase: N/A
• First received: November 19, 2014
• Last updated: May 10, 2017
• Start date: June 2012
• Est. completion date: November 2, 2015

Study information

• Verified date: May 2017
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: November 2, 2015
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colonic Polyps

Intervention

Other:
• Survey
Standard Gamble Survey

Locations

Country	Name	City	State
United States	Washington University in St. Louis	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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