UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030337
Receipt number R000034446
Scientific Title Evaluation of robot assisted laparoscopic radical cystectomy
Date of disclosure of the study information 2018/02/01
Last modified on 2017/12/11 07:59:35

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Basic information

Public title

Evaluation of robot assisted laparoscopic radical cystectomy

Acronym

Evaluation of robot assisted laparoscopic radicalcystectomy

Scientific Title

Evaluation of robot assisted laparoscopic radical cystectomy

Scientific Title:Acronym

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

1st name
Middle name
Last name Nasu Yasutomo

Organization

Okayama University

Division name

Urology

Zip code


Address

Shikatacho 2-5-1 okayama

TEL

0862357287

Email

kobayasu@md.okayama-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kobayashi Yasuyuki

Organization

Okayama University

Division name

Urology

Zip code


Address

Shikatacho 2-5-1 okayama

TEL

0862357287

Homepage URL


Email

kobayasu@md.okayama-u.ac.jp


Sponsor or person

Institute

Okayama university

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


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

Preinitiation

Date of protocol fixation

2017 Year 12 Month 11 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034446


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name