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

Adenoma Clinical Trial

Official title:

The Effect of Segmental Re-examination of Colon for Adenoma Detection in Colonoscopy: a Randomized, Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03268200
• Other study ID #: reexamination
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: July 2023
• Source: The Catholic University of Korea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: December 31, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenoma

Intervention

Other:
• segmental reexamination
segmental reexamination during colonoscopy

Locations

Country	Name	City	State
Korea, Republic of	Incheon St. Mary's hospital, Catholic university of Korea	Incheon

Sponsors (1)

Lead Sponsor	Collaborator
The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adenoma detection rate		7 days
Secondary	Per-patient adenoma detection rate (ADR) at each segment of colon		7 days
Secondary	per-patient polyp detection rate		7 days
Secondary	Withdrawal time		1 days