UMIN-CTR Clinical Trial

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