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
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
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
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
