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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006694
Receipt No. R000007888
Scientific Title A Prospective Multi-institutinal study of Perioperative and Functional Outcomes of Laparoscopic and Open Partial Nephrectomy
Date of disclosure of the study information 2011/11/11
Last modified on 2013/05/09

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Basic information
Public title A Prospective Multi-institutinal study of Perioperative and Functional Outcomes of Laparoscopic and Open Partial Nephrectomy
Acronym JSELPNSG
Scientific Title A Prospective Multi-institutinal study of Perioperative and Functional Outcomes of Laparoscopic and Open Partial Nephrectomy
Scientific Title:Acronym JSELPNSG
Region
Japan

Condition
Condition renal tumor
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify perioperative and functional outcomes of laparoscopic and open partial nephrectomy in Japan
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Perioperative outcome
renal function
Key secondary outcomes

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 who were clinically diagnosed with T1a renal cancer and received laparoscopic or open partial nephrectomy
Key exclusion criteria Patients who had a solitary kidney or received partial nephrectomy without renal arterial clumping
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoichi Arai
Organization Tohoku University School of Medicine
Division name Urology
Zip code
Address 1-1 Seiryo-machi, Aoba-ku, Sendai
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Akhiro Ito
Organization Tohoku University School of Medicine
Division name Urology
Zip code
Address
TEL 022-717-7278
Homepage URL
Email

Sponsor
Institute Department of Urology Tohoku University School of Medicine
Institute
Department

Funding Source
Organization Department of Urology Tohoku University School of Medicine
Organization
Division
Category of Funding Organization Self funding
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
2011 Year 11 Month 11 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
2010 Year 05 Month 06 Day
Date of IRB
Anticipated trial start date
2011 Year 05 Month 01 Day
Last follow-up date
2013 Year 04 Month 01 Day
Date of closure to data entry
2013 Year 05 Month 20 Day
Date trial data considered complete
2013 Year 06 Month 01 Day
Date analysis concluded
2013 Year 12 Month 01 Day

Other
Other related information pre- and post-operative renal function, perioperative outcomes, clinical findings, pathological diagnosis, perioperative complications


Management information
Registered date
2011 Year 11 Month 09 Day
Last modified on
2013 Year 05 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007888

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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