Detection Rate of Serrated Adenomas in Screening Colonoscopy

Completed

• Conditions: Healthy Patients Undergoing Screening Colonoscopy

• Registration Number: NCT03442270
• Lead Sponsor: TriHealth Inc.

Brief Summary

An observational prospective will be conducted to determine the detection rate of serrated adenoma during screening colonoscopy at our institution. Additionally, the variability of serrated adenoma detection among endoscopists will be evaluated and the characteristics of serrated adenomas will be described.

Detailed Description

Colonoscopy screening is a preventative measure for colorectal carcinoma (CRC), a highly malignant and dangerous cancer. Extensive research on the adenoma detection rate has provided national standards and quality metrics to help assess competence of endoscopists. Currently, there are no standards established for serrated adenomas. The proposed study would be conducted at Good Samaritan Hospital (GSH) and TriHealth Surgery Center West. This is an observational study and does not involve any patient interventions. However, because patient healthcare data will be collected for research, informed consent will be obtained shortly before the procedure. The main study objective is to determine the detection rate of serrated adenoma during screening colonoscopy at our institution. Additionally, the variability of serrated adenoma detection among endoscopists will be evaluated and the characteristics of serrated adenomas will be described.

Study Timeline

• Study First Submitted: 2018-02-16
• Study First Submitted QC: 2018-02-16
• Study First Posted: 2018-02-22
• Study Start: 2018-03-20
• Status Verified: 2018-05
• Primary Completion: 2018-11-07
• Study Completion: 2018-11-07
• Last Update Submitted: 2019-06-12
• Last Update Posted: 2019-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 276

Inclusion Criteria

• Males and females

Exclusion Criteria

• First degree relative (patient's parent, sibling or child) diagnosed with colorectal carcinoma at age of 59 or under
• New onset of iron deficiency anemia (within past 3 months)
• Abnormal imaging of colon within past 3 months
• Inadequate visualization reported by endoscopist
• Pregnant women

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serrated Adenoma	March 2018 to October 2018	Prevalence of Serrated Adenoma

Trial Locations

Locations (1)

Good Samaritan Hospital; 🇺🇸 Cincinnati, Ohio, United States