UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of robot assisted laparoscopic radical cystectomy
Title of the study (Brief title)	Evaluation of robot assisted laparoscopic radicalcystectomy
Region	Japan

Condition
Condition	Invasive Bladder cancer
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Evaluate the effectiveness and safety of robot-assisted total cystectomy using the da Vinci surgical system (DVSS) for patients with advanced bladder cancer, in whom total cystectomy is indicated.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Intraoperative bleeding volume
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Robot-assisted laparoscopic 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	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Transurethral bladder tumor resection was performed, and from the pathological findings it is a bladder cancer patient diagnosed as requiring bladder total resection. 2) Abdominal contrast CT or MRI has been diagnosed as resectable. 3) It is under 80 years old. 4) The age at the time of consent acquisition is over 20 years old. 5) For patient participation, written consent has been obtained from the patient himself.
Key exclusion criteria	1) Patient have active duplicated cancers. 2) Hemorrhagic diathesis or discontinuation of anticoagulant is impossible. 3) Patients with morbid obesity (Body mass Index: BMI>35. 4) Mental illness or psychiatric symptoms are merged, and judgment of participation in the examination is judged difficult. 5) It is a patient who may be pregnant or may be pregnant. 6) Patients with severe complications (liver disease, kidney disease, heart disease, lung disease, blood disease, autoimmune failure etc). 7) For other reasons, the investigator or test sharing doctor of the medical institution participating in this study (hereinafter referred to as the medical institution to be conducted) judges that participation in this exam is ineligible.
Target sample size	10

Research contact person
Name of lead principal investigator	Nasu Yasutomo
Organization	Okayama University
Division name	Urology
Address	Shikatacho 2-5-1 okayama
TEL	0862357287
Email	kobayasu@md.okayama-u.ac.jp

Public contact
Name of contact person	Kobayashi Yasuyuki
Organization	Okayama University
Division name	Urology
Address	Shikatacho 2-5-1 okayama
TEL	0862357287
Homepage URL
Email	kobayasu@md.okayama-u.ac.jp

Sponsor
Institute	Okayama university
Institute
Department

Funding Source
Organization	Okayama university
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	2018 Year 02 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 12 Month 11 Day
Anticipated trial start date	2018 Year 01 Month 20 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	2017 Year 12 Month 11 Day
Last modified on	2017 Year 12 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034446