Accuracy of Endoscopists in Predicting Polyp Pathology

Resected Polyp Clinical Trial

Official title:

Accuracy of Endoscopists in Predicting Polyp Pathology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03477318
• Other study ID #: 17-075
• Status: Completed
• Start date: March 20, 2018
• Est. completion date: November 7, 2018

Study information

• Verified date: May 2018
• Source: TriHealth Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: November 7, 2018
• Est. primary completion date: November 7, 2018
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Polyps
• Resected Polyp

Locations

Country	Name	City	State
United States	Good Samaritan Hospital	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
TriHealth Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Polyp prediction accuracy	Accuracy of predicting polyp type	up to 5 days