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Surrogate Quality Indicators for Adenoma Detection Rate (ADR)

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ClinicalTrials.gov Identifier: NCT03919487
Recruitment Status : Recruiting
First Posted : April 18, 2019
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Hyun Gun, Kim. M.D., Ph.D., Soonchunhyang University Hospital

Brief Summary:

This study is to evaluate the correlation of adenoma missing rate and quality indicators of colonoscopy including adenoma detection ratee (ADR), polyp detection rate (PDR), adenoma per colonoscopy rate (APC), adenoma per positive participant (APP), ADR-Plus, and to find out the surrogate indicators of ADR. This study is a prospective observational multi-center study. Correlation between AMR and quality indicators of colonoscopy based on the previous studies, 8 endoscopists participated in this study and will enroll 50 screening colonoscopies respectively.

Recruit research participants who want to participate in research in outpatient clinics. Perform colonoscopy in the morning after colon cleansing with split method. Colonoscopy is performed by back-to-back two consecutive colonoscopies. When the first colonoscopy is performed, the colonoscope is retracted after inserting the cecum, and all colon polyps are removed. After retracting to the anus of the first colonoscopy, the second colonoscopy is performed immediately. In case of newly detected colon polyps except for the small polyps and S-colon and rectal polyps which were left as photographs during the first colonoscopy with the second colonoscopy, we regard them as an overlooked lesion during the first colonoscopy. After the procedure, the histologic examination is confirmed and classified as benign lesions (all adenomas, advanced adenomas, dysplasia, and colorectal cancer) and non-lesion lesions.

Using the back-to-back colonoscopy results of the participants during the study period, calculate the quality indicators including ADR, PDR, APC, ADR-plus, APP and AMR for each endoscopist. And then, evaluate the correlation between AMR and other quality indicators.


Condition or disease Intervention/treatment
Colon Adenoma Procedure: Back to back colonoscopy

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Correlation Between Surrogate Quality Indicators for Adenoma Detection Rate (ADR) and Adenoma Miss Rate (AMR) in Qualified Colonoscopy: CORE Study
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Group/Cohort Intervention/treatment
Back-to-back colonoscopy group
As I described the study method in the protocol, the experimental group will be a screening colonoscopy cohort with back to back method. In fact, this study is to evaluate the correlation between quality indicators of colonoscopy and adenoma miss rate (AMR), and intervention is a single arm for back-to-back colonoscopy.
Procedure: Back to back colonoscopy
After first colonoscopy performing with polypectomy, the 2nd colonoscopy will be performed right after the 1st colonoscopy, and if the missed lesion during the 1st colonoscopy will be found, it should be removed.
Other Name: colonoscopy




Primary Outcome Measures :
  1. Correlation between adenoma missing rate during the colonoscopy and other colonoscopy quality indicators in each endoscopist. [ Time Frame: Within 1 year ]
    colonoscopy quality indicators including adenoma detection rate, polyp detection rate, adenoma per colonoscopy, adenoma detection rate-plus, adenoma per positive participant


Secondary Outcome Measures :
  1. Evaluation of surrogate indicators of ADR [ Time Frame: Within 1 year ]
    Correlation between ADR and other substitute indicators including PDR, APC, ADR-P



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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Community based, screening colonoscopy subjects
Criteria

Inclusion Criteria:

  • A 50-to 75-year-old colon cancer screening colonoscopist who has had previous colonoscopy experience or has had a colonoscopy within the last 5 years

Exclusion Criteria:

  1. Total bowel preparation deficient (total bowel preparation by Boston bowel preparation scale <6 or any region score <2)
  2. Inflammatory bowel disease patients
  3. Family history of hereditary colorectal cancer (family history of two or more colorectal cancer or family history of at least one cancer diagnosed before age 60)
  4. History of colorectal cancer or colon surgery
  5. If the insertion of the appendix fails
  6. A patient who does not agree with sleep induction calming

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): NCT03919487


Contacts
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Contact: Hyun GUn Kim, Professor 821091542969 medgun@schmc.ac.kr

Locations
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Korea, Republic of
Soonchunhyang univerisity hospital Recruiting
Seoul, Korea, Republic of, 140-743
Contact: Hyun Gun Kim, MD., PhD.       medgun@schmc.ac.kr   
Principal Investigator: Hyun Gun Kim, MD., PhD.         
Sponsors and Collaborators
Soonchunhyang University Hospital
Investigators
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Study Director: Hyun Gun Kim, Professor Soonchunhyang University College of Medicine

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Responsible Party: Hyun Gun, Kim. M.D., Ph.D., Professor, Soonchunhyang University Hospital
ClinicalTrials.gov Identifier: NCT03919487    
Other Study ID Numbers: CORE study
First Posted: April 18, 2019    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms