Detection Rate of Serrated Adenomas in Screening Colonoscopy

Healthy Patients Undergoing Screening Colonoscopy Clinical Trial

Official title:

Detection Rate of Serrated Adenomas in the Screening Colonoscopy Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03442270
• Other study ID #: 17-074
• 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

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 276
• Est. completion date: November 7, 2018
• Est. primary completion date: November 7, 2018
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Healthy Patients Undergoing Screening Colonoscopy

Intervention

Other:
• No Intervention
This is an observational study, so standard of care will be followed.

Locations

Country	Name	City	State
United States	Good Samaritan Hospital	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
TriHealth Inc.	TriHealth Hatton Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (1)

Kim HY, Kim SM, Seo JH, Park EH, Kim N, Lee DH. Age-specific prevalence of serrated lesions and their subtypes by screening colonoscopy: a retrospective study. BMC Gastroenterol. 2014 Apr 28;14:82. doi: 10.1186/1471-230X-14-82. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serrated Adenoma	Prevalence of Serrated Adenoma	March 2018 to October 2018