UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062494 |
|---|---|
| Receipt number | R000071532 |
| Scientific Title | A Single-center Prospective Randomized Controlled Trial Evaluating the Effectiveness of Video-based Educational Material for Basic Endoscopic Skills Training in Novice Medical Students |
| Date of disclosure of the study information | 2026/09/30 |
| Last modified on | 2026/08/06 11:41:41 |
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Basic information
Public title
Effectiveness of Video-based Educational Material for Basic Gastrointestinal Endoscopy Training: A Prospective Randomized Controlled Trial
Acronym
VIDEO-ENDO
Scientific Title
A Single-center Prospective Randomized Controlled Trial Evaluating the Effectiveness of Video-based Educational Material for Basic Endoscopic Skills Training in Novice Medical Students
Scientific Title:Acronym
VIDEO-ENDO
Region
| Japan |
Condition
Condition
None (Educational study)
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate whether video-based educational material simultaneously visualizing endoscope tip movement and hand manipulation improves the acquisition of basic endoscopic skills compared with conventional verbal instruction in novice medical students. The primary outcome is task completion time, and the secondary outcomes are success rates of retroflexion and stretching maneuvers, comprehension, and learner satisfaction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Task completion time (seconds) for the endoscopy simulator task, assessed immediately after the educational intervention
Key secondary outcomes
* Success rate of the retroflexion maneuver (assessed immediately after the educational intervention)
* Success rate of the stretching maneuver (assessed immediately after the educational intervention)
* Comprehension score (assessed immediately after the educational intervention)
* Learner satisfaction score (assessed immediately after the educational intervention)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
Video-based education group: Participants will watch a 10-minute educational video simultaneously visualizing endoscope tip movement and hand manipulation (angulation, torque, insertion, and withdrawal), followed by retroflexion and stretching tasks using an Accutouch endoscopy simulator.
Interventions/Control_2
Conventional instruction group: Participants will receive approximately 10 minutes of conventional verbal instruction from an instructor, followed by retroflexion and stretching tasks using an Accutouch endoscopy simulator.
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
* Aged 18 years or older
* Clinical clerkship medical students at Okayama University Medical School
* Provision of written informed consent
* No previous experience in gastrointestinal endoscopy
Key exclusion criteria
* Previous experience in performing upper gastrointestinal endoscopy, colonoscopy, or pancreatobiliary endoscopy
* Individuals judged by the principal investigator or a study investigator to be unsuitable for participation in the study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kazuyuki |
| Middle name | |
| Last name | Matsumoto |
Organization
Okayama University
Division name
Department of Endoscopy, Institute for Medical, Pharmaceutical and Health Sciences
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
TEL
096-235-7219
matsumoto.k@okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Akihiro |
| Middle name | |
| Last name | Matsumi |
Organization
Okayama University
Division name
Department of Endoscopy, Institute for Medical, Pharmaceutical and Health Sciences
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
TEL
086-235-7219
Homepage URL
akihiro.matsumi.gastro@gmail.com
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Foundation for Medical Science and Medical Welfare
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama University Clinical Research Review Committee
Address
2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
Tel
086-235-7991
ouh-crrb@adm.okayama-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
| 2026 | Year | 09 | Month | 30 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 08 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | 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
Management information
Registered date
| 2026 | Year | 08 | Month | 06 | Day |
Last modified on
| 2026 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071532
