Clinical trial NCT02193646: Endoscopic Size Assessment of Advanced Adenomatous Polyps
Official title: Endoscopic Size Assessment of Advanced Adenomatous Polyps; Inter Observer Variations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adenoma Detection Rate Improvement in Screening Colonoscopy
Keywords: Colonoscopy
Adenoma
ADR
Screening Colon Cancer
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2014-07-17
Enrollment: 1930
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects undergoing screening colonoscopies at Rush University Medical Center.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Adenomatous Polyp Detection Rate
timeFrame: one year
measure: Endoscopic Size Assessment Versus Pathological Size Assessment
timeFrame: one year
Secondary outcomes:
measure: Retroflexion as an indication of adenoma detection rate in colorectal cancer screening
timeFrame: one year
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Amanda Lin
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Muhammad Alsayid, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Van J, Alsayid M, Ma K, Vemulapalli K, Rex D, Melson J. Impact of Cold Snare vs Cold Forceps Resection of Diminutive Adenomas on Segmental Incomplete Resection Rate. Am J Gastroenterol. 2023 Aug 1;118(8):1410-1418. doi: 10.14309/ajg.0000000000002289. Epub 2023 Apr 11.
citation: Alsayid M, Van J, Ma K, Melson J. Segmental metachronous adenoma rate as a metric for monitoring incomplete resection in a colonoscopy screening program. Gastrointest Endosc. 2021 Aug;94(2):347-354. doi: 10.1016/j.gie.2021.01.046. Epub 2021 Feb 6.