UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050363 |
|---|---|
| Receipt number | R000053459 |
| Scientific Title | Education of diagnosis for cryptorchidism |
| Date of disclosure of the study information | 2023/02/16 |
| Last modified on | 2023/08/18 09:19:01 |
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Basic information
Public title
Education of diagnosis for cryptorchidism
Acronym
Education of diagnosis for cryptorchidism
Scientific Title
Education of diagnosis for cryptorchidism
Scientific Title:Acronym
Education of diagnosis for cryptorchidism
Region
| Japan |
Condition
Condition
cryptorchidism
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Diagnosis of cryptorchidism is primarily by palpation, looking from the groin to the scrotum. Previously, it was thought that even if a child had cryptorchidism at birth, spontaneous descent would be expected until after 1 year of age. However, recent epidemiological studies have revealed that spontaneous descending of the testis is up to 3 months after birth (6 months in preterm birth), and testicular fixation should be performed from 6 months to 18 months after birth for cryptorchidism. is recommended. It is important to make an appropriate diagnosis of cryptorchidism at an appropriate time so that orchiopexy can be performed at an appropriate time. We will teach pediatrics and urology residents about simple examination methods, and evaluate the usefulness of these methods.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Usefulness of examination guidance for cryptorchidism for pediatrics and urology interns
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Guidance on pathophysiology and diagnostic methods for cryptorchidism
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
Pediatrics and Urology Resident in Nara Medical University Hospital
Key exclusion criteria
Physicians judged inappropriate by the principal investigator and co-investigator
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yosuke |
| Middle name | |
| Last name | Morizawa |
Organization
Nara medical university
Division name
Urology
Zip code
634-8521
Address
840 Shijo-cho, Kashihara, Nara 634-8522 Japan
TEL
0744223051
tigers.yosuke@gmail.com
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Morizawa |
Organization
Nara medical university
Division name
Urology
Zip code
634-8521
Address
840 Shijo-cho, Kashihara, Nara 634-8522 Japan
TEL
0744223051
Homepage URL
tigers.yosuke@gmail.com
Sponsor or person
Institute
Nara medical university
Institute
Department
Personal name
Yosuke Morizawa
Funding Source
Organization
Nara medical university
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
Nara medical university
Address
840 Shijo-cho, Kashihara, Nara 634-8522 Japan
Tel
0744223051
tigers.yosuke@gmail.com
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
| 2023 | Year | 02 | Month | 16 | 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
25
Results
Self-reported scores on understanding of CO, confidence for the infant scrotal exam, and diagnostic accuracy of CO were increased before and after a proctored session.
Results date posted
| 2023 | Year | 08 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
7 first residents, 11 pediatrics residents, and 7 urology residents
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2022 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 28 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2023 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2023 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2023 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 02 | Month | 16 | Day |
Last modified on
| 2023 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000053459
| 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 |
