Surrogate Quality Indicators for Adenoma Detection Rate (ADR)

NCT03919487 | Completed

• 1 other identifier: CORE study
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Colon Adenoma

Outcome Measures

Primary Outcomes (1)

• Correlation between adenoma missing rate during the colonoscopy and other colonoscopy quality indicators in each endoscopist.

  colonoscopy quality indicators including adenoma detection rate, polyp detection rate, adenoma per colonoscopy, adenoma detection rate-plus, adenoma per positive participant

  Within 1 year

Secondary Outcomes (1)

• Evaluation of surrogate indicators of ADR

  Within 1 year

Study Arms (1)

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

Interventions

Back to back colonoscopy PROCEDURE

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.

Also known as: colonoscopy

Back-to-back colonoscopy group

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community based, screening colonoscopy subjects

You may qualify if:

• 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

You may not qualify if:

• Total bowel preparation deficient (total bowel preparation by Boston bowel preparation scale \<6 or any region score \<2)
• Inflammatory bowel disease patients
• 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)
• History of colorectal cancer or colon surgery
• If the insertion of the appendix fails
• A patient who does not agree with sleep induction calming

Sponsors & Collaborators

• Soonchunhyang University Hospital: lead

Study Sites (1)

Soonchunhyang univerisity hospital

Seoul, 140-743, South Korea

Location

MeSH Terms

Interventions

Colonoscopy

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Hyun Gun Kim, Professor

  Soonchunhyang University College of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 7, 2019
• First Posted: April 18, 2019
• Study Start: July 1, 2018
• Primary Completion: June 30, 2020
• Study Completion: December 18, 2020
• Last Updated: March 10, 2021

Record last verified: 2021-03

Locations

KR (1)