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Detection Rate of Serrated Adenomas in Screening Colonoscopy

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ClinicalTrials.gov Identifier: NCT03442270
Recruitment Status : Completed
First Posted : February 22, 2018
Last Update Posted : June 14, 2019
Sponsor:
Collaborator:
TriHealth Hatton Research Institute
Information provided by (Responsible Party):
TriHealth Inc.

Tracking Information
First Submitted Date February 16, 2018
First Posted Date February 22, 2018
Last Update Posted Date June 14, 2019
Actual Study Start Date March 20, 2018
Actual Primary Completion Date November 7, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 16, 2018)
Serrated Adenoma [ Time Frame: March 2018 to October 2018 ]
Prevalence of Serrated Adenoma
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03442270 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Detection Rate of Serrated Adenomas in Screening Colonoscopy
Official Title Detection Rate of Serrated Adenomas in the Screening Colonoscopy Population
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.
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 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.
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients 50 years or older undergoing first-time colonoscopy screening
Condition Healthy Patients Undergoing Screening Colonoscopy
Intervention Other: No Intervention
This is an observational study, so standard of care will be followed.
Study Groups/Cohorts Not Provided
Publications * Kim HY, Kim SM, Seo JH, Park EH, Kim N, Lee DH. Age-specific prevalence of serrated lesions and their subtypes by screening colonoscopy: a retrospective study. BMC Gastroenterol. 2014 Apr 28;14:82. doi: 10.1186/1471-230X-14-82.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 12, 2019)
276
Original Estimated Enrollment
 (submitted: February 16, 2018)
310
Actual Study Completion Date November 7, 2018
Actual Primary Completion Date November 7, 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03442270
Other Study ID Numbers 17-074
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party TriHealth Inc.
Study Sponsor TriHealth Inc.
Collaborators TriHealth Hatton Research Institute
Investigators Not Provided
PRS Account TriHealth Inc.
Verification Date May 2018