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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000023786
Receipt No. R000027405
Scientific Title Outcomes of robot-assisted laparoscopic pyeloplasty
Date of disclosure of the study information 2016/09/01
Last modified on 2017/02/28

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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
Last name of lead principal investigator
1st name
Middle name
Last name Yasuhiro Kaiho
Organization Tohoku University Graduate School of Medicine
Division name Urology
Zip code
Address 1-1 Seiryomachi, Aoba-ku, Sendai 980-8575, Japan
TEL 022-717-7278
Email kaiho@uro.med.tohoku.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Yasuhiro Kaiho
Organization Tohoku University Graduate School of Medicine
Division name Urology
Zip code
Address 1-1 Seiryomachi, Aoba-ku, Sendai 980-8575, Japan
TEL 022-717-7278
Homepage URL
Email kaiho@uro.med.tohoku.ac.jp

Sponsor
Institute Department of Urology, Tohoku University Graduate School of Medicine (Director: Prof. Yoichi Arai)
Institute
Department

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
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 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
Date of protocol fixation
2014 Year 04 Month 22 Day
Date of IRB
Anticipated trial start date
2014 Year 04 Month 22 Day
Last follow-up date
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
2017 Year 02 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027405

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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