UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060082 |
|---|---|
| Receipt number | R000068717 |
| Scientific Title | Evaluation of colonoscopy insertion technique improvement in trainees from various countries using Mikoto colonoscopy model (International Mikoto Study) |
| Date of disclosure of the study information | 2025/12/15 |
| Last modified on | 2025/12/15 03:59:26 |
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Basic information
Public title
Evaluation of colonoscopy insertion technique improvement in trainees from various countries using Mikoto colonoscopy model (International Mikoto Study)
Acronym
International Mikoto Study
Scientific Title
Evaluation of colonoscopy insertion technique improvement in trainees from various countries using Mikoto colonoscopy model (International Mikoto Study)
Scientific Title:Acronym
International Mikoto Study
Region
| Japan | Asia(except Japan) | North America |
Condition
Condition
Colonoscopy recipients
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify whether training using the Mikoto colonoscopy model in a multicenter international setting improves colonoscopy insertion techniques among trainees.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
cecal intubation rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
mikoto training group
Interventions/Control_2
mikoto non-training group
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients between 18 and 90 who undergo colonoscopy
2) Patients who need colonoscopy (patients who meet one of the following conditions)
Patients with positive fecal immunochemical test
Patients who have been diagnosed or treated for colorectal adenoma or colorectal cancer (patients who have undergone colorectal resection are not eligible)
Patients with gastrointestinal symptoms such as abdominal pain, diarrhea, constipation, etc
Patients who need to be screened for gastrointestinal cancer
Patients with a family history of colorectal cancer or colorectal adenoma
Key exclusion criteria
1) Patients who have undergone bowel resection
2) Patients with a history of inflammatory bowel disease
3) Patients with a history of familial adenomatous polyposis
4) Patients with a history of hereditary non-polyposis colorectal cancer
5) Patients with previously known severe intestinal adhesions
6) Patients with severe obesity (BMI > 35 kg/m2)
7) Patients who are pregnant
8) Patients whose previous colonoscopy was judged by the investigator to have been difficult to insert (insertion time > 15 minutes) or who had poor colonoscopy preparation (Modified Aronchick Scale: Poor/Inadequate)
9) Patients who are judged by the investigator to be unable to participate in the study.
10) Patients who declared non-participation in the study
Target sample size
420
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Yamaguchi |
Organization
Saga University
Division name
Gastroenterology
Zip code
8498501
Address
5-1-1 Nabeshima Saga
TEL
0952316511
daisukehawks@gmail.com
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Yamaguchi |
Organization
Saga University
Division name
Gastroenterology
Zip code
8498501
Address
5-1-1 Nabeshima Saga
TEL
0952316511
Homepage URL
daisukehawks@gmail.com
Sponsor or person
Institute
Saga 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
The Ethics Review Committee of Saga University
Address
5-1-1 Nabeshima Saga
Tel
0952343400
kenkyu-shinsei@ml.cc.saga-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
| 2025 | Year | 12 | Month | 15 | 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
| 2024 | Year | 05 | Month | 03 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 02 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 14 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 12 | Month | 15 | Day |
Last modified on
| 2025 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068717
