Clinical trial NCT02305251: Patient Preferences of a Resect and Discard Paradigm
Official title: Patient Preferences of a Resect and Discard Paradigm
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colonic Polyps
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2014-12-02
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients reporting in for colonoscopies either for screening or for polyp surveillance.

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.

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.

Eligibility 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

Primary outcomes:
measure: Number of participants willing to pay out of pocket for pathology costs when a diminutive polyp is found.
timeFrame: June, 2012 to March, 2014: up to 2 years
Secondary outcomes:
measure: The factors that influence patients' decisions to pay or not pay for pathology costs with their own money.
timeFrame: June, 2012 to March, 2014: up to 2 years
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Dayna S Early, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
citation: 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.