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Recruitment status Terminated
Unique ID issued by UMIN UMIN000025646
Receipt No. R000029507
Scientific Title Intravesical laparoscopic ureteral reimplantation for vesicoureteral reflux and megaureter
Date of disclosure of the study information 2017/01/12
Last modified on 2017/01/12

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Basic information
Public title Intravesical laparoscopic ureteral reimplantation for vesicoureteral reflux and megaureter
Acronym Intravesical laparoscopic ureteral reimplantation for VUR
Scientific Title Intravesical laparoscopic ureteral reimplantation for vesicoureteral reflux and megaureter
Scientific Title:Acronym Intravesical laparoscopic ureteral reimplantation for VUR
Region
Japan

Condition
Condition vesicoureteral reflux, megaureter
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the usefulness and safety of intravesical laparoscopic surgery for vesicoureteral reflux and megaureter
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes perioperative complication, surgical time, blood loss
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 Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 We perform intravesical laparoscopic surgery for VUR and megaureter.
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
3 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 3 years old or older
Key exclusion criteria less than three years old
neurogenic bladder
Target sample size 3

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Katsuya Aoki
Organization Nara Medical University
Division name Department of Urology
Zip code
Address 840 Shijo-cho, Kashihara, Nara
TEL 0744-22-3051
Email aokik@naramed-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Katsuya Aoki
Organization Nara Medical University
Division name Department of Urology
Zip code
Address 840 Shijo-cho, Kashihara, Nara
TEL 0744-22-3051
Homepage URL
Email aokik@naramed-u.ac.jp

Sponsor
Institute Nara Medical University
Institute
Department

Funding Source
Organization Nara Medical University
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
2017 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 Terminated
Date of protocol fixation
2012 Year 02 Month 15 Day
Date of IRB
Anticipated trial start date
2012 Year 02 Month 15 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
2017 Year 01 Month 12 Day
Last modified on
2017 Year 01 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029507

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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