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 | 2024/08/05 14:58:08 |
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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
https://www.thieme-connect.de/products/ejournals/html/10.1055/a-2248-5110
Publication of results
Published
Result
URL related to results and publications
https://www.thieme-connect.de/products/ejournals/html/10.1055/a-2248-5110
Number of participants that the trial has enrolled
50
Results
The hemostasis success rate of the trainees significantly increased after instruction (64% vs. 86%, P < 0.05). The success rate for ulcers in the upper body of the stomach (59%), a high-difficulty site, was significantly lower than that for ulcers in the antrum, even after feedback and instruction. Trainee self-perceived proficiency and confidence significantly improved after simulation-based training (P < 0.05).
Results date posted
| 2024 | Year | 08 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Study design and participants
This prospective educational study recruited 50 gastroenterology residents from tertiary referral university hospitals in Japan and Canada between February 2019 and August 2020. Only gastroenterology trainees were considered for inclusion. Medical students, junior residents, and trainees who did not consent were excluded from the study.
Participant flow
After providing informed consent, trainees completed questionnaires before and after training, which assessed their confidence in performing hemostatic procedures and the effectiveness of the training. We created a mechanical simulator for endoscopic hemostasis (Medical Rising STAR -Ulcer type). Briefly, the ulcer model made of an elastomer resembling human mucosal elasticity could reproduce spurting bleeding from selected artificial vessels, and ulcers could be installed anywhere in the stomach lumen, which was designed based on human data. For this program, we used two bleeding gastrointestinal ulcers for each trainee: one placed on the greater curvature in the antrum of the stomach and one on the upper body of the posterior wall of the stomach. At least two expert endoscopists supported each trainee during the training. First, trainees attempted endoscopic hemostasis of the first vessel (A-1) of the antral ulcer without any feedback. Trainees could try up to three clips for a maximum of 15 minutes for each vessel. Time measurement started when the trainee recognized the ulcer lesion on the monitor. After completing the first trial without technical instruction, the expert endoscopists provided feedback and tips to the trainees, including tips regarding maintaining an appropriate view and distance from the ulcer, stabilizing the endoscope in position, and how to grasp an exposed vessel with a hemostatic clip.
Adverse events
nothing
Outcome measures
Outcome measures
We aimed to perform a comprehensive evaluation of the efficacy including both objective measures of skill improvement and subjective measures of confidence enhancement. Our primary outcome was to evaluate the efficacy of the training program using our novel simulation model. To assess this, we compared the success rates of hemostasis for antral ulcer bleeding before A1 and after A2 instructions. Success was achieved when proper vessel grasping and hemostasis were accomplished within three clips and 15 minutes per vessel. Failure was defined as the inability to achieve hemostasis with three clips or if the procedure time exceeded 15 minutes per vessel. We also compared trainee self-confidence and subjective evaluation of their skills using a Visual Analog Scale before and after training.
The secondary outcome was to identify factors related to the difficulty of upper gastrointestinal endoscopic hemostasis and to evaluate how well this model reproduces the challenges encountered in clinical settings. To evaluate this, we compared the success rates of hemostasis for antral ulcers after instruction A2 and ulcers in the posterior wall of the upper body of the stomach B1, thus assessing the reproducibility of site-dependent difficulty within the model.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
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
| 2024 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040709
