Patient Preferences of a Resect and Discard Paradigm

NCT02305251 | Completed

• 1 other identifier: 201202031
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Colonic Polyps

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The factors that influence patients' decisions to pay or not pay for pathology costs with their own money.

  June, 2012 to March, 2014: up to 2 years

Interventions

Survey OTHER

Standard Gamble Survey

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Indication for colonoscopy is screening or routine polyp surveillance

You may not qualify if:

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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

Related Publications (3)

• 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.

  PMID: 20621680 BACKGROUND

• 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.

  PMID: 19187781 BACKGROUND

• 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.

  PMID: 25910663 DERIVED

MeSH Terms

Conditions

Colonic Polyps

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Dayna S Early, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: November 19, 2014
• First Posted: December 2, 2014
• Study Start: June 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: November 2, 2015
• Last Updated: May 11, 2017

Record last verified: 2017-05

Locations

US (1)