Endoscopic Size Assessment of Advanced Adenomatous Polyps

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: Recruiting
• Conditions: Adenoma Detection Rate Improvement in Screening Colonoscopy

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: GI Research; Phone Number: 312-942-3466; Email: gi_research@rush.edu
• Study Contact Backup: Name: Amanda Lin; Phone Number: 3125633907; Email: amanda_f_lin@rush.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • Amanda Lin
      • Contact: Amanda Lin; Phone Number: 312-563-3907; Email: amanda_f_lin@rush.edu
      • Contact: Solomon Adelowo; Phone Number: 843-597-4268; Email: Solomon_O_Adelowo@rush.edu
      • Sub-Investigator: Salina Lee, MD
      • Sub-Investigator: Joshua Melson, MD
      • Principal Investigator: Muhammad Alsayid, MD
      • Sub-Investigator: Faraz Bishehsari, MD

Participation Criteria

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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adenomatous Polyp Detection Rate	Assessing for advanced adenomas (including location).	one year
Endoscopic Size Assessment Versus Pathological Size Assessment	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	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

• Sponsor: Rush University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2010
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

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): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 13, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Colonoscopy; Adenoma; ADR; Screening Colon Cancer
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Adenoma; Adenomatous Polyps
• Other Study ID Numbers: ESA-2014

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No