NCT03268200

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

1.8 years

First QC Date

August 29, 2017

Last Update Submit

July 24, 2023

Conditions

Adenoma

Outcome Measures

Primary Outcomes (1)

  • Adenoma detection rate

    7 days

Secondary Outcomes (3)

  • Per-patient adenoma detection rate (ADR) at each segment of colon

    7 days

  • per-patient polyp detection rate

    7 days

  • Withdrawal time

    1 days

Study Arms (2)

Case group

EXPERIMENTAL

Each segment of colon (right colon, mid-colon, and left colon) was examined twice

Other: segmental reexamination

Control group

NO INTERVENTION

Withdrawal time in the each segment of colon (right colon, mid-colon, and left colon) was about 2 minutes.

Interventions

segmental reexaminationOTHER

segmental reexamination during colonoscopy

Case group

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients (aged ≥45 and ≤75 years) who were scheduled to un- dergo colonoscopy

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Incheon St. Mary's hospital, Catholic university of Korea

Incheon, 403-720, South Korea

Location

Related Publications (1)

  • Lee DS, Ji JS, Gweon TG, Seo M, Choi H. Efficacy of colonoscopic re-examination across the entire colon: a randomized controlled trial. Surg Endosc. 2024 Nov;38(11):6711-6717. doi: 10.1007/s00464-024-11298-5. Epub 2024 Sep 26.

    PMID: 39327294DERIVED

MeSH Terms

Conditions

Adenoma

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 29, 2017

First Posted

August 31, 2017

Study Start

September 1, 2017

Primary Completion

June 30, 2019

Study Completion

December 31, 2019

Last Updated

July 27, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)