UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061963 |
|---|---|
| Receipt number | R000070901 |
| Scientific Title | Evaluation of the Usefulness of a Digital Educational Tool in Robot-Assisted Radical Cystectomy: A Randomized Controlled Trial Assessing Reduction in Face-to-Face Counseling Time and Patient Comprehension |
| Date of disclosure of the study information | 2026/06/25 |
| Last modified on | 2026/06/18 15:30:24 |
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Basic information
Public title
Evaluation of the Usefulness of a Digital Educational Tool in Robot-Assisted Radical Cystectomy: A Comparative Study of Reduction in Face-to-Face Counseling Time and Patient Comprehension
Acronym
Digital Surgical Education Study
Scientific Title
Evaluation of the Usefulness of a Digital Educational Tool in Robot-Assisted Radical Cystectomy: A Randomized Controlled Trial Assessing Reduction in Face-to-Face Counseling Time and Patient Comprehension
Scientific Title:Acronym
DIRECT-RARC Study
Region
| Japan |
Condition
Condition
Bladder Cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The primary objective of this study is to evaluate whether preoperative viewing of a video created using the surgical explanation application "DICTOR" can significantly reduce the duration of face-to-face explanations provided by physicians. Through this approach, the study aims to improve operational efficiency in clinical practice and contribute to reducing physicians' workload. Furthermore, the study seeks to standardize the content of explanations by digitalizing routine explanations, thereby eliminating variability among physicians and establishing a system that enables consistent and high-quality information delivery to all patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Duration of face-to-face preoperative counseling provided by physicians
Key secondary outcomes
Score on the surgical procedure comprehension test
Preoperative anxiety level
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
DICTOR Viewing Group
Participants in the intervention group will, prior to the conventional physician led verbal explanation, view a standardized educational video using a dedicated tablet device. The video provides information regarding disease pathology surgical procedures anticipated complications and postoperative course. The video is linked to a QR code allowing patients to access and view it remotely using their own smartphones or other devices regardless of location including at home.
After viewing the video, participants will receive face to face counseling in the outpatient clinic followed by acquisition of written informed consent. In addition, after completion of the face to face explanation, participants will be asked to complete a study specific questionnaire and a knowledge assessment test which are expected to require approximately 5 to 10 minutes.
A total of 15 participants are planned to be enrolled in this group.
Interventions/Control_2
Conventional Explanation Group
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
Patients diagnosed with bladder cancer and scheduled to undergo robot-assisted radical cystectomy and ileal conduit urinary diversion.
Key exclusion criteria
Participants who meet any of the following criteria will be excluded from the study:
1. Individuals judged to have difficulty viewing the video or completing the questionnaire due to severe cognitive impairment or other conditions.
2. Individuals who are unable to adequately understand the explanatory video provided in Japanese.
3. Individuals deemed unsuitable for participation in the study by the attending physician for any other reason.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Naoya |
| Middle name | |
| Last name | Masumori |
Organization
Sapporo Medical University
Division name
Department of Urology
Zip code
060-8543
Address
291 Minami 1-jo Nishi 16-chome, Chuo-ku, Sapporo, Hokkaido, Japan
TEL
011-611-2111
masumori@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Kirisawa |
Organization
Sapporo Medical University
Division name
Department of Urology
Zip code
060-8543
Address
291 Minami 1-jo Nishi 16-chome, Chuo-ku, Sapporo, Hokkaido, Japan
TEL
011-611-2111
Homepage URL
kirisawa.t@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
Naoya Masumori
Funding Source
Organization
None
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
Sapporo Medical University
Address
Minami 1-jo Nishi 17-chome, Chuo-ku, Sapporo, Hokkaido, Japan
Tel
011-611-2111
ji-rskk@sapmed.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
札幌医科大学附属病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 25 | 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 | 04 | Month | 23 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 22 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 22 | Day |
Last follow-up date
| 2028 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2028 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 06 | Month | 18 | Day |
Last modified on
| 2026 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070901
