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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025339
Receipt No. R000029152
Scientific Title A retrospective Multicenter Study to Assess the Safety and Efficacy of Robot-assisted (da Vinci surgical system, DVSS) Partial Nephrectomy for small renal tumors.
Date of disclosure of the study information 2016/12/20
Last modified on 2016/12/20

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Basic information
Public title A retrospective Multicenter Study to Assess the Safety and Efficacy of Robot-assisted (da Vinci surgical system, DVSS) Partial Nephrectomy for small renal tumors.
Acronym A retrospective Multicenter Study to Assess the Safety and Efficacy of Robot-assited Partial Nephrectomy
Scientific Title A retrospective Multicenter Study to Assess the Safety and Efficacy of Robot-assisted (da Vinci surgical system, DVSS) Partial Nephrectomy for small renal tumors.
Scientific Title:Acronym A retrospective Multicenter Study to Assess the Safety and Efficacy of Robot-assited Partial Nephrectomy
Region
Japan

Condition
Condition Small renal tumors
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the safety and efficacy of robot-assisted (da Vinci surgical system, DVSS) partial nephrectomy for small renal tumors performed at multi-institutions in Japan.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes - Oncological outcome: margin status, recurrence-free survival
- Renal function: Warm ischemia time, serum creatinine, eGFR
- Safety outcomes:Adverse Events
- Other outcomes: Operative Time, Blood Loss
Key secondary outcomes - Assessment of factors that affect post-operative kidney function
- Assessment of learning curves for robot-assisted partial nephrectomy
- Assessment of changes of pre- and post- operative eGFR

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with small renal tumors who received Robot-assisted partial nephrectomy between January 2011 and March 2016
Key exclusion criteria Patients who deny the enrollment of this study
Target sample size 900

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masato Fujisawa
Organization Kobe University Graduate School of Medicine
Division name Division of Urology, Department of Surgery Related
Zip code
Address 7-5-2, Kusunokicho, Chuoku, Kobe, 650-0017, Japan
TEL 078-382-6155
Email uro6155@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Junya Furukawa
Organization Kobe University Graduate School of Medicine
Division name Division of Urology, Department of Surgery Related
Zip code
Address 7-5-2, Kusunokicho, Chuoku, Kobe, 650-0017, Japan
TEL 078-382-6155
Homepage URL
Email uro6155@med.kobe-u.ac.jp

Sponsor
Institute Kobe University Graduate School of Medicine
Division of Urology, Department of Surgery Related
Institute
Department

Funding Source
Organization none
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 神戸大学医学部附属病院を含め約60施設

Other administrative information
Date of disclosure of the study information
2016 Year 12 Month 20 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
2016 Year 05 Month 06 Day
Date of IRB
Anticipated trial start date
2016 Year 06 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2016 Year 12 Month 20 Day
Last modified on
2016 Year 12 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029152

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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