Detection Rate of Serrated Adenomas in Screening Colonoscopy
June 12, 2019 updated by: TriHealth Inc.
Detection Rate of Serrated Adenomas in the Screening Colonoscopy Population
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.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
276
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Cincinnati, Ohio, United States, 45220
- Good Samaritan Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients 50 years or older undergoing first-time colonoscopy screening
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Serrated Adenoma
Time Frame: March 2018 to October 2018
|
Prevalence of Serrated Adenoma
|
March 2018 to October 2018
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 20, 2018
Primary Completion (Actual)
November 7, 2018
Study Completion (Actual)
November 7, 2018
Study Registration Dates
First Submitted
February 16, 2018
First Submitted That Met QC Criteria
February 16, 2018
First Posted (Actual)
February 22, 2018
Study Record Updates
Last Update Posted (Actual)
June 14, 2019
Last Update Submitted That Met QC Criteria
June 12, 2019
Last Verified
May 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17-074
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.