UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058816 |
|---|---|
| Receipt number | R000067216 |
| Scientific Title | Association Between Endoscopist Fatigue Accumulation and the Quality of Colonoscopy in Afternoon Procedures |
| Date of disclosure of the study information | 2025/08/17 |
| Last modified on | 2025/08/18 09:50:32 |
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Basic information
Public title
Association Between Endoscopist Fatigue Accumulation and the Quality of Colonoscopy in Afternoon Procedures
Acronym
Impact of Endoscopist Fatigue on Colonoscopy Quality in the Afternoon
Scientific Title
Association Between Endoscopist Fatigue Accumulation and the Quality of Colonoscopy in Afternoon Procedures
Scientific Title:Acronym
Association Between Endoscopist Fatigue Accumulation and the Quality of Colonoscopy in Afternoon Procedures
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the degree of endoscopist fatigue and to examine whether fatigue accumulation, as influenced by the time of day and the number of procedures, affects colonoscopy quality.
Basic objectives2
Others
Basic objectives -Others
Assessing whether fatigue accumulation occurs among colonoscopists and whether it is associated with a decline in colonoscopy quality may contribute to improving work efficiency and promoting sustainable working practices by maintaining endoscopist health. Moreover, the findings of this study will serve as essential baseline data for future large-scale prospective interventional trials, with considerable medical significance.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
adenoma detection rate
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. From the date of approval by the head of the research institution until March 2028, patients scheduled to undergo colonoscopy in the afternoon at the institution, performed by an experienced physician (with experience of at least 500 colonoscopies) for screening, surveillance, or diagnostic purposes.
2. Patients who have provided informed consent to participate in the study and are at least 18 years of age at the time of consent.
Key exclusion criteria
None
Target sample size
488
Research contact person
Name of lead principal investigator
| 1st name | Natsumi |
| Middle name | |
| Last name | Maeda |
Organization
Osaka Metropolitan University
Division name
Department of Gastroenterology, Graduate School of Medicine
Zip code
545-8585
Address
1-4-3, Asahimachi, Abeno-ku
TEL
06-6645-3811
natsu072407@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Natsumi |
| Middle name | |
| Last name | Maeda |
Organization
Osaka Metropolitan University
Division name
Department of Gastroenterology, Graduate School of Medicine
Zip code
545-8585
Address
1-4-3, Asahimachi, Abeno-ku
TEL
06-6645-3811
Homepage URL
natsu072407@yahoo.co.jp
Sponsor or person
Institute
Osaka Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board (IRB), Osaka Metropolitan University Hospital
Address
1-2-7, Asahimachi, Abeno-ku
Tel
06-6645-3456
gr-a-knky-ethics@omu.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
| 2025 | Year | 08 | Month | 17 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 08 | Month | 12 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 12 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 18 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study aims to evaluate the degree of endoscopist fatigue and to examine whether fatigue accumulation related to the time of day and the number of procedures affects colonoscopy quality.
Management information
Registered date
| 2025 | Year | 08 | Month | 16 | Day |
Last modified on
| 2025 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067216
