Accuracy of Endoscopists in Predicting Polyp Pathology

The study purpose is to assess the accuracy of experienced endoscopists at a community hospital in predicting histological types of polyps resected at colonoscopy using white light. Patients 50 years or older undergoing first-time screening colonoscopy will be included in this observational study.

Study Overview

• Status: Completed
• Conditions: Resected Polyp

Detailed Description

The study purpose is to assess the accuracy of experienced endoscopists at a community hospital in predicting histological types of polyps resected at colonoscopy using white light. The study will be conducted at Good Samaritan Hospital and TriHealth Surgery Center West. Study participants include patients 50 years or older undergoing first-time screening colonoscopy. This is an observational study and does not involve any patient interventions. After completing the colonoscopy, the endoscopist will document their prediction of the polyp type. The polyp type predicted by the endoscopist will be compared to the polyp type documented in the pathology report to determine accuracy. It is estimated that study enrollment will take 6 months.

• Study Type: Observational
• Enrollment (Actual): 159

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45220
      • Good Samaritan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients 50 years or older undergoing first-time screening colonoscopy

Description

Inclusion Criteria:

• Males and females

Exclusion Criteria:

• first degree relative diagnosed with colorectal carcinoma at age 59 or under
• New onset of iron deficiency anemia (within past 3 months)
• Abnormal imaging of colon within past 3 months
• Pregnant women
• Inadequate visualization reported by endoscopist

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients undergoing screening colonoscopy; Patients undergoing first-time colonoscopy using white light with at least 1 polyp resected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Polyp prediction accuracy	Accuracy of predicting polyp type	up to 5 days

Collaborators and Investigators

• Sponsor: TriHealth Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2018
• Primary Completion (Actual): November 7, 2018
• Study Completion (Actual): November 7, 2018

Study Registration Dates

• First Submitted: March 20, 2018
• First Submitted That Met QC Criteria: March 20, 2018
• First Posted (Actual): March 26, 2018

Study Record Updates

• Last Update Posted (Actual): June 14, 2019
• Last Update Submitted That Met QC Criteria: June 12, 2019
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: colonoscopy, polyp, endoscopist
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Polyps
• Other Study ID Numbers: 17-075

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No