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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000039978
Receipt No. R000045579
Scientific Title Clinical Outcomes of Open and Laparoscopic Urological Surgery in Gifu University Hospital
Date of disclosure of the study information 2020/03/31
Last modified on 2020/03/30

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Basic information
Public title Clinical Outcomes of Open and Laparoscopic Urological Surgery in Gifu University Hospital
Acronym Clinical Outcomes of Open and Laparoscopic Urological Surgery in Gifu University Hospital
Scientific Title Clinical Outcomes of Open and Laparoscopic Urological Surgery in Gifu University Hospital
Scientific Title:Acronym Clinical Outcomes of Open and Laparoscopic Urological Surgery in Gifu University Hospital
Region
Japan

Condition
Condition Urological malignancies
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To analyze and disclose clinical outcomes of urological surgery
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Overall survival
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
18 years-old <
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria For patients who meet all of the following criteria.
1) 20 years or older at surgical time with no age limit.
2) Regardless of gender.
3) Patients who underwent open or laparoscopic surgery at our institution.
4) Regardless with or without distant metastasis.
5) Regardless with or without preoperative therapy.
Key exclusion criteria Exclude patients who meet any of the following criteria.
1) Patients determined to be inappropriate by the doctor's judgement.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Keita
Middle name
Last name Nakane
Organization Gifu University Hospital
Division name Department of Urology
Zip code 501-1194
Address Yanagido 1-1, Gifu, Japan
TEL 058-230-6338
Email keitaco@gifu-u.ac.jp

Public contact
Name of contact person
1st name Keita
Middle name
Last name Nakane
Organization Gifu University Hospital
Division name Department of Urology
Zip code 501-1194
Address Yanagido 1-1, Gifu, Japan
TEL 058-230-6338
Homepage URL
Email keitaco@gifu-u.ac.jp

Sponsor
Institute Department of Urology, Gifu University Hospital
Institute
Department

Funding Source
Organization Department of Urology, Gifu University Hospital
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 Institutional Review Board of Gifu University School of Medicine
Address Yanagido 1-1, Gifu Japan
Tel 058-230-6059
Email rinri@gifu-u.ac.jp

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
2020 Year 03 Month 31 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 300
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 No longer recruiting
Date of protocol fixation
2018 Year 07 Month 04 Day
Date of IRB
2018 Year 07 Month 04 Day
Anticipated trial start date
2018 Year 07 Month 04 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2020 Year 03 Month 30 Day
Last modified on
2020 Year 03 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045579

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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