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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
The Catholic University of Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Adenoma

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
August 29, 2017
Last Updated
July 24, 2023
Sponsor
The Catholic University of Korea
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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

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The Effect of Segmental Re-examination of Colon for Adenoma Detection in Colonoscopy

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