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OpenTrials
Completed

NCT Number: NCT03442270

Detection Rate of Serrated Adenomas in Screening Colonoscopy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

This is an observational study, so standard of care will be followed.

Primary outcomes

  1. Serrated Adenoma

    Time frame: March 2018 to October 2018

    Prevalence of Serrated Adenoma

Sponsors and collaborators

Lead sponsor

TriHealth Inc.

Other

Collaborators

  • TriHealth Hatton Research Institute

Registry information

Official study title

Detection Rate of Serrated Adenomas in the Screening Colonoscopy Population

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 22, 2018
Registry last updated
Jun 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.