Endoscopic Size Assessment of Advanced Adenomatous Polyps

January 17, 2025 updated by: Rush University Medical Center

Endoscopic Size Assessment of Advanced Adenomatous Polyps; Inter Observer Variations

The investigators are retrospectively comparing detection rates of adenomatous polyps, advanced adenomas, and size assessment of the polyps among Rush University Medical Center endoscopists. The investigators plan to review whether the size assessment of adenomatous polyps affected the surveillance protocols and if the location of polyps detected affected the detection rates.

Study Overview

Status

Completed

Conditions

Detailed Description

The study plans to compare detection rates of adenomatous as well as the sessile serrated polyps, advanced adenomas and size assessment of the polyps among the endoscopists at the study site. In addition, the study team aims to evaluate rates of advanced neoplasia on surveillance colonoscopy based on certain features on initial colonoscopy and patient characteristics, including specific high-risk histologic features and concurrent medication usage such as aspirin. In addition, patients with at least one adenoma on surveillance colonoscopy will be identified and regarded as cases. Cases will be compared against normal surveillance colonoscopy. The Controls will be selected on a 1:1 ratio. Aspirin use will be compared between groups.

Study Type

Observational

Enrollment (Actual)

1930

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

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Amanda Lin

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

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Subjects undergoing screening colonoscopies at Rush University Medical Center.

Description

Inclusion Criteria:

  • Presence of adenomatous polyps detected at endoscopy and diagnosed pathologically by tissue biopsy
  • Have a colonoscopy at RUMC for screening purposes

Exclusion Criteria:

  • Failure to meet inclusion criteria
  • Previous diagnosis of IBD or colorectal cancer

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adenomatous Polyp Detection Rate
Time Frame: one year
Assessing for advanced adenomas (including location).
one year
Endoscopic Size Assessment Versus Pathological Size Assessment
Time Frame: one year
Size of polyps at time of endoscopic procedure will be compared to the size of the same polyp by pathological assessment.
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retroflexion as an indication of adenoma detection rate in colorectal cancer screening
Time Frame: one year
Retroflexion is a common but not mandatory practice in colonoscopy which as not been systematically studied in terms of polyp detection. Charts will be reviewed to determine whether retroflexion was performed.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rush University Medical Center

Investigators

  • Principal Investigator: Muhammad Alsayid, MD, Rush University Medical Center

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.

General Publications

Helpful Links

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)

November 1, 2010

Primary Completion (Actual)

January 1, 2025

Study Completion (Actual)

January 1, 2025

Study Registration Dates

First Submitted

July 14, 2014

First Submitted That Met QC Criteria

July 15, 2014

First Posted (Estimated)

July 17, 2014

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 17, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESA-2014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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