UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035735 |
|---|---|
| Receipt number | R000040709 |
| Scientific Title | Educational intervention study on effectiveness of novel simulation model for upper gastrointestinal endoscopic hemostasis |
| Date of disclosure of the study information | 2019/02/01 |
| Last modified on | 2023/08/08 14:58:00 |
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Basic information
Public title
Educational intervention study on effectiveness of novel simulation model for upper gastrointestinal endoscopic hemostasis
Acronym
Educational intervention study on effectiveness of novel simulation model for upper gastrointestinal endoscopic hemostasis
Scientific Title
Educational intervention study on effectiveness of novel simulation model for upper gastrointestinal endoscopic hemostasis
Scientific Title:Acronym
Educational intervention study on effectiveness of novel simulation model for upper gastrointestinal endoscopic hemostasis
Region
| Japan | North America |
Condition
Condition
Gastrointestinal bleeding
Classification by specialty
| Gastroenterology | Gastrointestinal surgery | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of novel simulation model for endoscopic hemostasis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate effectiveness of the novel simulation model for endoscopic trainee.
Key secondary outcomes
To clarify factors associated with difficulty of upper gastrointestinal endoscopic hemostasis.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Investigator will take informed consent from participants by oral agreement. Then participants will complete the questionnaires both before and after simulation training. Training for endoscopic hemostasis will be provided using bleeding ulcer models attaching with antrum and body of stomach. This model has been developed by the investigators and Denka corporation. Investigator will msure time of procedure and also give appropriate technical feedback to trainee.
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
Gastroenterological doctor or resident doctor who is belonging to McMaster University, Tohoku University, or related hospitals of Tohoku University.
Key exclusion criteria
Exclusion criteria will be the trainees who cannot speak English in Canada,and who cannot speak Japanese in Japan.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Koike |
Organization
Tohoku University Hospital
Division name
Division of Gastroenterology
Zip code
980-8575
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575 JAPAN
TEL
022-717-7171
tkoike@rd5.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Kanno |
Organization
Tohoku University graduate school of Medicine
Division name
Division of Gastroenterology
Zip code
980-8575
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575 JAPAN
TEL
022-717-7171
Homepage URL
kanno.takeshi@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Division of Gastroenterology, McMaster University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8575, JAPAN
Tel
+81-22-717-8007
med-kenkyo@grp.tohoku.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
| 2019 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
50
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 31 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
The results of the simulator learning effectiveness for resident physicians were presented in an oral presentation at the American Gastroenterological Association Week (DDW2021) and a paper is being prepared. We have also completed additional recruitment of non-gastroenterologists. The integrated results are also being analyzed and a paper is being prepared.
Management information
Registered date
| 2019 | Year | 02 | Month | 01 | Day |
Last modified on
| 2023 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040709
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
