UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023786 |
|---|---|
| Receipt number | R000027405 |
| Scientific Title | Outcomes of robot-assisted laparoscopic pyeloplasty |
| Date of disclosure of the study information | 2016/09/01 |
| Last modified on | 2021/09/02 11:22:39 |
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Basic information
Public title
Outcomes of robot-assisted laparoscopic pyeloplasty
Acronym
Outcomes of robot-assisted laparoscopic pyeloplasty
Scientific Title
Outcomes of robot-assisted laparoscopic pyeloplasty
Scientific Title:Acronym
Outcomes of robot-assisted laparoscopic pyeloplasty
Region
| Japan |
Condition
Condition
Congenital hydronephrosis
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assessment of safety and efficacy in robot-assisted laparoscopic pyeloplasty
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Complication of surgery,
Key secondary outcomes
Operation time, pain scare, serum creatinine at 6 and 12 months after surgery and renal functions using MAG3 renal scintigraphy
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
| Device,equipment |
Interventions/Control_1
Pyeloplasty using da Vinci Robotic surgical System during surgery
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
| 12 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Existence of flank pain, pyelonephritis, renal stone and hypertension for congenital hydronephrosis due to the pelvis-ureter junction stenosis or possibility of progressive asymptomatic renal dysfunction
Key exclusion criteria
Patients who do not agree the study
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Kaiho |
Organization
Tohoku University Graduate School of Medicine
Division name
Urology
Zip code
980-8574
Address
1-1 Seiryomachi, Aoba-ku, Sendai 980-8575, Japan
TEL
022-717-7278
kaiho@uro.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Kaiho |
Organization
Tohoku University Graduate School of Medicine
Division name
Urology
Zip code
9808574
Address
1-1 Seiryomachi, Aoba-ku, Sendai 980-8575, Japan
TEL
022-717-7278
Homepage URL
kaiho@uro.med.tohoku.ac.jp
Sponsor or person
Institute
Department of Urology, Tohoku University Graduate School of Medicine (Director: Prof. Yoichi Arai)
Institute
Department
Personal name
Funding Source
Organization
Department of Urology, Tohoku University Graduate School of Medicine (Director: Prof. Yoichi Arai)
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
Department of Urology, Tohoku University Graduate School of Medicine
Address
1-1 Seiryoumachi, Aoba, Sendai, Japan
Tel
022-717-7278
kaiho@uro.med.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
| 2016 | Year | 09 | Month | 01 | 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
Completed
Date of protocol fixation
| 2014 | Year | 04 | Month | 22 | Day |
Date of IRB
| 2014 | Year | 04 | Month | 22 | Day |
Anticipated trial start date
| 2014 | Year | 04 | Month | 22 | Day |
Last follow-up date
| 2017 | 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
| 2016 | Year | 08 | Month | 26 | Day |
Last modified on
| 2021 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027405
