UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025339 |
|---|---|
| Receipt number | 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 18:00:23 |
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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
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
uro6155@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Medicine
Division of Urology, Department of Surgery Related
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029152
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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