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Accuracy of Endoscopists in Predicting Polyp Pathology

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ClinicalTrials.gov Identifier: NCT03477318
Recruitment Status : Completed
First Posted : March 26, 2018
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
TriHealth Inc.

Brief Summary:
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.

Condition or disease
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.

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Study Type : Observational
Actual Enrollment : 159 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Accuracy of Endoscopists in Predicting Polyp Pathology
Actual Study Start Date : March 20, 2018
Actual Primary Completion Date : November 7, 2018
Actual Study Completion Date : November 7, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

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



Primary Outcome Measures :
  1. Polyp prediction accuracy [ Time Frame: up to 5 days ]
    Accuracy of predicting polyp type



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients 50 years or older undergoing first-time screening colonoscopy
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03477318


Locations
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United States, Ohio
Good Samaritan Hospital
Cincinnati, Ohio, United States, 45220
Sponsors and Collaborators
TriHealth Inc.

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Responsible Party: TriHealth Inc.
ClinicalTrials.gov Identifier: NCT03477318     History of Changes
Other Study ID Numbers: 17-075
First Posted: March 26, 2018    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by TriHealth Inc.:
colonoscopy, polyp, endoscopist

Additional relevant MeSH terms:
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Polyps
Pathological Conditions, Anatomical