UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical study for rabot-assisted laparoscopic radical cystectomy
Title of the study (Brief title)	Clinical study for RARC
Region	Japan

Condition
Condition	bladder cancer
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The objective of this study is to assess the ustility of robot-assisted laparoscopic radical cystectomy for patients with nonmetastatic muscle-invasive bladder cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Perioperative adverse events
Key secondary outcomes	operative time, blood loss

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Patinets with nonmetastatic muscle invasive bladder cancer, who take part in this study, will be treated with robot-assisted laparoscopic radical cystectomy.
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 bladder cancer Patients who agree to receive robot-assisted laparoscopic radical cystectomy (Prior to start the study, wrriten informed consent will be required for all participants)
Key exclusion criteria	1. Patients with active double cancers 2. Patients possibly in pregnant 3. Patients who are not optimal candidates for laparoscopic surgery 4. Patients who are not candidates for this study
Target sample size	10

Research contact person
Name of lead principal investigator	Hideaki Miyake
Organization	Hamamatsu University School of Medicine
Division name	Department of Urology
Address	1-20-1 Handayama, Higashi-Ku, Hamamatsu 431-3192, Japan
TEL	0534352306
Email	hmiyake@hama-med.ac.jp

Public contact
Name of contact person	Hideaki Miyake
Organization	Hamamatsu University School of Medicine
Division name	Department of Urology
Address	1-20-1 Handayama, Higashi-Ku, Hamamatsu 431-3192, Japan
TEL	0534352306
Homepage URL
Email	hmiyake@hama-med.ac.jp

Sponsor
Institute	Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization	Hamamatsu University School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2016 Year 12 Month 01 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 10 Month 11 Day
Anticipated trial start date	2016 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 11 Month 11 Day
Last modified on	2016 Year 11 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028541