UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study of safety and efficacy of robot assisted surgery
Title of the study (Brief title)	Aimed to find out how inflammation will be develop during robot assisted surgery
Region	Japan

Condition
Condition	malignant tumor of the bladder
Classification by specialty	Urology Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Aimed to find out how inflammation will be develop during robot assisted surgery
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To estimate safety and efficacy of robot assisted surgery with quantifing stress and inflammation related substance.
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	Patient who has robot assisted surgery for bladder malignant tumor
Key exclusion criteria	Patient wothout inforned consent, who has robot assisted surgery for bladder malignant tumor
Target sample size	15

Research contact person
Name of lead principal investigator	Tetsuya Kushikata
Organization	Hirosaki University
Division name	Department of Anesthesiology, Graduate School of Medicine
Address	Zaifu 5, Hirosaki, Aomori
TEL	0172335111
Email	tetsuyak@cc.hirosaki-u.ac.jp

Public contact
Name of contact person	Tetsuya Kushikata
Organization	Hirosaki University
Division name	Department of Anesthesiology, Graduate School of Medicine
Address	Zaifu 5, Hirosaki, Aomori
TEL	0172335111
Homepage URL
Email	tetsuyak@cc.hirosaki-u.ac.jp

Sponsor
Institute	Department of Anesthesiology, Hirosaki University Graduate School of Medicine
Institute
Department

Funding Source
Organization	N/A
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	2013 Year 12 Month 11 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 11 Month 28 Day
Anticipated trial start date	2013 Year 12 Month 11 Day
Last follow-up date	2018 Year 12 Month 11 Day
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	analysis data obtained
Other related information	Robot-assisted surgery has a merit of low-invasive. It is expected to reduce blood-loss and wound size even though in case of high invasive surgery like total cystectomy. Robot-assisted surgery has different approach from ordinary laparotomy; thus, it may possible to develop unexpected complication mesenteric traction syndrome. Purpose of this study is to evaluate safety and efficacy of a robot-assisted surgery. We investigate usual blood examination and changes in stress/inflammation related substances (catecholamine, cortisol, orexin, urotensin II, procalcitonin, presepsin, endotoxin, etc.).

Management information
Registered date	2013 Year 12 Month 11 Day
Last modified on	2018 Year 12 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014681