The Effect of Segmental Re-examination of Colon for Adenoma Detection in Colonoscopy
Primary Purpose
Adenoma
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
segmental reexamination
Sponsored by

About this trial
This is an interventional diagnostic trial for Adenoma
Eligibility Criteria
Inclusion Criteria:
- Patients (aged ≥45 and ≤75 years) who were scheduled to un- dergo colonoscopy
Exclusion Criteria:
- Patients who had advanced colonic cancer, prior resection of the proximal colon, inflammatory bowel disease, or polyposis syndrome, or were unable to provide informed consent.
- If the quality of bowel preparation was unsatisfactory (Boston Bowel Preparation Scale [BBPS] score <2 in any segment of the colon), or if the cecum could not be intubated during the colonoscopy, patients were excluded.
Sites / Locations
- Incheon St. Mary's hospital, Catholic university of Korea
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Case group
Control group
Arm Description
Each segment of colon (right colon, mid-colon, and left colon) was examined twice
Withdrawal time in the each segment of colon (right colon, mid-colon, and left colon) was about 2 minutes.
Outcomes
Primary Outcome Measures
Adenoma detection rate
Secondary Outcome Measures
Per-patient adenoma detection rate (ADR) at each segment of colon
per-patient polyp detection rate
Withdrawal time
Full Information
NCT ID
NCT03268200
First Posted
August 29, 2017
Last Updated
July 24, 2023
Sponsor
The Catholic University of Korea
1. Study Identification
Unique Protocol Identification Number
NCT03268200
Brief Title
The Effect of Segmental Re-examination of Colon for Adenoma Detection in Colonoscopy
Official Title
The Effect of Segmental Re-examination of Colon for Adenoma Detection in Colonoscopy: a Randomized, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Catholic University of Korea
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aim of this study was to determine whether segmental re-examination of the each segment (right colon, mid-colon, and left colon) could increase the proximal adenoma detection rate (ADR) and to evaluate the time-effectiveness of this approach.
Detailed Description
The investigators prospectively recruited patients (aged ≥45 and ≤75 years) who were scheduled to undergo colonoscopy at our center. Patients were excluded if they had advanced colonic cancer, prior resection of the proximal colon, inflammatory bowel disease, or polyposis syndrome, or were unable to provide informed consent. In addition, if the quality of bowel preparation was unsatisfactory (Boston Bowel Preparation Scale [BBPS] score <2 in any segment of the colon), or if the cecum could not be intubated during the colonoscopy, patients were excluded.
A randomization list was generated with the randomization algorithm of random sorting, using Excel program. Included patients were randomly assigned to one of the two groups: segmental re-examination group, in which the each segment (right colon, mid-colon, and left colon) was examined twice segmentally; or control group, in which the withdrawal time in the each segment was about 2 minutes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
450 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Case group
Arm Type
Experimental
Arm Description
Each segment of colon (right colon, mid-colon, and left colon) was examined twice
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Withdrawal time in the each segment of colon (right colon, mid-colon, and left colon) was about 2 minutes.
Intervention Type
Other
Intervention Name(s)
segmental reexamination
Intervention Description
segmental reexamination during colonoscopy
Primary Outcome Measure Information:
Title
Adenoma detection rate
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Per-patient adenoma detection rate (ADR) at each segment of colon
Time Frame
7 days
Title
per-patient polyp detection rate
Time Frame
7 days
Title
Withdrawal time
Time Frame
1 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients (aged ≥45 and ≤75 years) who were scheduled to un- dergo colonoscopy
Exclusion Criteria:
Patients who had advanced colonic cancer, prior resection of the proximal colon, inflammatory bowel disease, or polyposis syndrome, or were unable to provide informed consent.
If the quality of bowel preparation was unsatisfactory (Boston Bowel Preparation Scale [BBPS] score <2 in any segment of the colon), or if the cecum could not be intubated during the colonoscopy, patients were excluded.
Facility Information:
Facility Name
Incheon St. Mary's hospital, Catholic university of Korea
City
Incheon
ZIP/Postal Code
403-720
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Segmental Re-examination of Colon for Adenoma Detection in Colonoscopy
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