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Trial record 4 of 300 for:    Recruiting, Not yet recruiting, Available Studies | "Adenoma"

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

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ClinicalTrials.gov Identifier: NCT03268200
Recruitment Status : Recruiting
First Posted : August 31, 2017
Last Update Posted : September 7, 2017
Sponsor:
Information provided by (Responsible Party):
Jeong-Seon Ji, The Catholic University of Korea

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.

Condition or disease Intervention/treatment Phase
Adenoma Other: segmental reexamination Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1052 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: The Effect of Segmental Re-examination of Colon for Adenoma Detection in Colonoscopy: a Randomized, Controlled Trial
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : August 31, 2018
Estimated Study Completion Date : August 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arm Intervention/treatment
Experimental: Case group
Each segment of colon (right colon, mid-colon, and left colon) was examined twice
Other: segmental reexamination
segmental reexamination during colonoscopy

No Intervention: Control group
Withdrawal time in the each segment of colon (right colon, mid-colon, and left colon) was about 2 minutes.



Primary Outcome Measures :
  1. Adenoma detection rate [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. Per-patient adenoma detection rate (ADR) at each segment of colon [ Time Frame: 7 days ]
  2. per-patient polyp detection rate [ Time Frame: 7 days ]
  3. Withdrawal time [ Time Frame: 1 days ]


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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03268200


Contacts
Contact: Jeong-Seon Ji, PhD +82-32-280-5051 jjsdr@catholic.ac.kr

Locations
Korea, Republic of
Incheon St. Mary's hospital, Catholic university of Korea Recruiting
Incheon, Korea, Republic of, 403-720
Contact: Jeong-Seon Ji, MD, PhD       jjsdr@catholic.ac.kr   
Sponsors and Collaborators
The Catholic University of Korea

Responsible Party: Jeong-Seon Ji, Professor, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT03268200     History of Changes
Other Study ID Numbers: reexamination
First Posted: August 31, 2017    Key Record Dates
Last Update Posted: September 7, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms