UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053397 |
|---|---|
| Receipt number | R000060675 |
| Scientific Title | Investigation of Efficacy and Safety in Robot-Assisted Laparoscopic Urologic Reconstruction Procedures. |
| Date of disclosure of the study information | 2024/01/19 |
| Last modified on | 2024/01/19 20:04:20 |
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Basic information
Public title
Investigation of Efficacy and Safety in Robot-Assisted Laparoscopic Urologic Reconstruction Procedures.
Acronym
Investigation of Efficacy and Safety in Robot-Assisted Laparoscopic Urologic Reconstruction Procedures.
Scientific Title
Investigation of Efficacy and Safety in Robot-Assisted Laparoscopic Urologic Reconstruction Procedures.
Scientific Title:Acronym
Investigation of Efficacy and Safety in Robot-Assisted Laparoscopic Urologic Reconstruction Procedures.
Region
| Japan |
Condition
Condition
Investigation of Efficacy and Safety in Robot-Assisted Laparoscopic Urologic Reconstruction Procedures.
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluating the Efficacy and Safety of Robot-Assisted Laparoscopic Urologic Reconstruction.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary Outcome Measure: Surgical Success Rate
Presence or Absence of Postoperative Urinary Passage Obstructions.
Post-urologic reconstruction, clinical data such as details of each participant's surgery and test results will be collected from medical records. The progress will be tracked from the perioperative period up to five years postoperatively to confirm the efficacy and safety of this surgical technique.
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
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
For urinary tract injuries, Robot-Assisted Laparoscopic Urologic Reconstruction will be performed.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients requiring urologic reconstruction due to urinary tract injuries or ureteral strictures. This includes patients with postoperatively identified urinary tract injuries who have consented to robot-assisted surgery. The surgical procedures involved are uretero-ureterostomy (K787), ureteroneocystostomy (K786, K810), and ureteroenteric bladder anastomosis (K789).
Key exclusion criteria
Patients who are unable or unwilling to cooperate with this study. Patients for whom laparoscopic surgery is medically contraindicated. Repair procedures for urinary tract injuries or strictures that occur or are identified during surgery.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Kobayashi |
Organization
Kyoto University
Division name
Department of Urology, Graduate school of Medicine
Zip code
6068507
Address
54, Shogoin Kawahara-cho, Sakyo-ku, Kyoto-shi, Kyoto
TEL
0757513337
selecao@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Kimihiko |
| Middle name | |
| Last name | Masui |
Organization
Kyoto University
Division name
Department of Urology, Graduate school of Medicine
Zip code
6068507
Address
54, Shogoin Kawahara-cho, Sakyo-ku, Kyoto-shi, Kyoto
TEL
0757513337
Homepage URL
kimimasu1389@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Self-funding of research expenses
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida Konoe-cho, Sakyo-ku, Kyoto
Tel
0757534680
ethcom@kuhp.kyoto-u.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
| 2024 | Year | 01 | Month | 19 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 12 | Month | 07 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 07 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2032 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 01 | Month | 19 | Day |
Last modified on
| 2024 | Year | 01 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060675
| 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 |
