Accuracy of Endoscopists in Predicting Polyp Pathology

NCT ID: NCT03477318

Last Updated: 2019-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

159 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-20

Study Completion Date

2018-11-07

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Resected Polyp

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients undergoing screening colonoscopy

Patients undergoing first-time colonoscopy using white light with at least 1 polyp resected.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TriHealth Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Good Samaritan Hospital

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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17-075

Identifier Type: -

Identifier Source: org_study_id

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