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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020461
Receipt No. R000023591
Scientific Title A Study of Robotic Assisted Laparoscopic Pyeloplasty
Date of disclosure of the study information 2016/01/12
Last modified on 2020/07/10

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Basic information
Public title A Study of Robotic Assisted Laparoscopic Pyeloplasty
Acronym A Study of Robotic Pyeloplasty
Scientific Title A Study of Robotic Assisted Laparoscopic Pyeloplasty
Scientific Title:Acronym A Study of Robotic Pyeloplasty
Region
Japan

Condition
Condition ureteropelvic junction obstruction
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Analysis of perioperative data of Robotic Assisted Laparoscopic Pyeloplasty
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Time of operation
Key secondary outcomes bleeding, Visual Analogue Scale,Complications,renal function,hospital stay,success rate

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Robotic Assisted Laparoscopic Pyeloplasty for ureteropelvic junction obstruction
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
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria ureteropelvic junction obstruction
Key exclusion criteria Past histry of intraabdominal surgery
Target sample size 6

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuyuki Naitoh
Organization Kyoto Prefectural University of Medecine
Division name Urology
Zip code
Address Kajiicho-Kamigyouku
TEL 075-251-5595
Email naitoh@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasuyuki Naitoh
Organization Kyoto Prefectural University of Medecine
Division name Urology
Zip code
Address Kajiicho-Kamigyouku
TEL 075-251-5595
Homepage URL
Email naitoh@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medecine
Institute
Department

Funding Source
Organization Kyoto Prefectural University of Medecine
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
Address
Tel
Email

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 01 Month 12 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
2015 Year 02 Month 12 Day
Date of IRB
2020 Year 06 Month 11 Day
Anticipated trial start date
2016 Year 01 Month 12 Day
Last follow-up date
2020 Year 06 Month 11 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 01 Month 06 Day
Last modified on
2020 Year 07 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023591

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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