UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056908 |
|---|---|
| Receipt number | R000065040 |
| Scientific Title | Cohort study to evaluate the usefulness of viewing a surgical explanatory video for patients scheduled for robot-assisted radical prostatectomy |
| Date of disclosure of the study information | 2025/02/03 |
| Last modified on | 2026/03/04 09:49:49 |
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Basic information
Public title
Cohort study to evaluate the usefulness of viewing a surgical explanatory video for patients scheduled for robot-assisted radical prostatectomy
Acronym
Cohort study to evaluate the usefulness of viewing a surgical explanatory video for patients scheduled for robot-assisted radical prostatectomy
Scientific Title
Cohort study to evaluate the usefulness of viewing a surgical explanatory video for patients scheduled for robot-assisted radical prostatectomy
Scientific Title:Acronym
Cohort study to evaluate the usefulness of viewing a surgical explanatory video for patients scheduled for robot-assisted radical prostatectomy
Region
| Japan |
Condition
Condition
prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To test the usefulness of incorporating a surgical explanation video into verbal surgical explanations to patients scheduled for robot-assisted radical prostatectomy to improve patient understanding of the surgical procedure.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Differences in patient understanding of preoperative explanation of robot-assisted radical prostatectomy between physician explanation group and video viewing group
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Physician explanation group: the urologist will explain the robot-assisted radical prostatectomy procedure according to the surgical procedure instructions form.
Interventions/Control_2
Explanation video group: surgical explanation of the robot-assisted radical prostatectomy will be provided by watching the surgical explanation video.
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
| 80 | years-old | >= |
Gender
Male
Key inclusion criteria
1.Patients diagnosed with prostate cancer
2.Patients scheduled to undergo robot-assisted radical prostatectomy treatment
3.Patients who have agreed to participate in this study
Key exclusion criteria
Patients with limited ability to communicate in Japanese (those who have not completed compulsory education and foreigners who do not fully understand Japanese)
Target sample size
205
Research contact person
Name of lead principal investigator
| 1st name | Junya |
| Middle name | |
| Last name | Hata |
Organization
Fukushima Medical University
Division name
Department of Urology
Zip code
960-1295
Address
1 Hikarigaoka, Fukushima City, Fukushima
TEL
024-547-1111
akju826@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Harigane |
Organization
Fukushima Medical University
Division name
Department of Urology
Zip code
960-1295
Address
1 Hikarigaoka, Fukushima City, Fukushima
TEL
024-547-1111
Homepage URL
uroharry@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Fukushima Medical University
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukushima Medical University
Address
1 Hikarigaoka, Fukushima City, Fukushima
Tel
024-547-1111
uroharry@fmu.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 | 02 | Month | 03 | 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
| 2024 | Year | 03 | Month | 13 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 17 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2028 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2028 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2028 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 02 | Month | 02 | Day |
Last modified on
| 2026 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065040
