UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055817 |
|---|---|
| Receipt number | R000063718 |
| Scientific Title | Assessment of Colorectal Polyp Detection by Short-Axis Direction:Retrospective study |
| Date of disclosure of the study information | 2024/10/12 |
| Last modified on | 2024/10/11 23:26:20 |
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Basic information
Public title
Assessment of Colorectal Polyp Detection by Short-Axis Direction:Retrospective study
Acronym
Assessment of Colorectal Polyp Detection by Short-Axis Direction:Retrospective study
Scientific Title
Assessment of Colorectal Polyp Detection by Short-Axis Direction:Retrospective study
Scientific Title:Acronym
Assessment of Colorectal Polyp Detection by Short-Axis Direction:Retrospective study
Region
| Japan |
Condition
Condition
Colorectal Polyp
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The detection of colorectal polyps during colonoscopy can be influenced by factors such as lesion location, size, morphology, and histological type. This study aimed to evaluate the difficulty of detecting colorectal polyps based on their orientation in the short-axis direction of the colon.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The short-axis direction of the colon was divided into eight directions (A-H), and the direction of each detected polyp was recorded. Polyp detection rates were compared across the short-axis directions and clinicopathological features, including lesion size, location, macroscopic type, and examiner experience.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Colorectal lesions newly detected and endoscopically resected during the study period, lesions for which adequate still images were available to assess the short axis, and lesions with complete information regarding the examination and lesion characteristics.
Key exclusion criteria
Cases with missing information, cases in which polyps had been identified in prior colonoscopy, cases with active bleeding, post-colorectal cancer surgery cases, patients with inflammatory bowel disease, and those with lesions pathologically diagnosed as neuroendocrine tumors were excluded from the analysis.
Target sample size
522
Research contact person
Name of lead principal investigator
| 1st name | Daichi |
| Middle name | |
| Last name | Mori |
Organization
Showa University School of Medicine
Division name
Department of Medicine, Division of Gastroenterology
Zip code
1428666
Address
1-5-8 Hatanodai, Shinagawa-ku, Japan
TEL
0337848535
d.mori@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Katagiri |
Organization
Showa University School of Medicine
Division name
Department of Medicine, Division of Gastroenterology
Zip code
1428666
Address
1-5-8 Hatanodai, Shinagawa-ku, Japan
TEL
0337848535
Homepage URL
katsushi@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Showa University
Address
1-5-8 Hatanodai, Shinagawa-ku, Japan
Tel
0337848535
ctsc.admin@ofc.showa-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 16 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A retrospective analysis was conducted on 522 patients who underwent colonoscopy at Showa University Hospital between November 2022 and February 2023.
Management information
Registered date
| 2024 | Year | 10 | Month | 11 | Day |
Last modified on
| 2024 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063718
