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Detection Rate of Serrated Adenomas in Screening Colonoscopy

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ClinicalTrials.gov Identifier: NCT03442270
Recruitment Status : Not yet recruiting
First Posted : February 22, 2018
Last Update Posted : February 22, 2018
Sponsor:
Collaborator:
TriHealth Hatton Research Institute
Information provided by (Responsible Party):
TriHealth Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment
Healthy Patients Undergoing Screening Colonoscopy Other: No Intervention

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 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
Estimated Enrollment : 310 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Detection Rate of Serrated Adenomas in the Screening Colonoscopy Population
Estimated Study Start Date : March 2018
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources


Intervention Details:
    Other: No Intervention
    This is an observational study, so standard of care will be followed.


Primary Outcome Measures :
  1. Serrated Adenoma [ Time Frame: March 2018 to October 2018 ]
    Prevalence of Serrated Adenoma



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients 50 years or older undergoing first-time colonoscopy screening
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03442270


Contacts
Contact: Jenni S Steinbrunner, BS 513-862-4033 jenni_steinbrunner@trihealth.com
Contact: Birmaji Ali, MD 513-862-8216 birmaji_ali@trihealth.com

Locations
United States, Ohio
Good Samaritan Hospital
Cincinnati, Ohio, United States, 45220
Sponsors and Collaborators
TriHealth Inc.
TriHealth Hatton Research Institute

Publications:
Responsible Party: TriHealth Inc.
ClinicalTrials.gov Identifier: NCT03442270     History of Changes
Other Study ID Numbers: 17-074
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: February 22, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by TriHealth Inc.:
Serrated Adenoma, Colonoscopy

Additional relevant MeSH terms:
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms