UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019055 |
|---|---|
| Receipt number | R000022035 |
| Scientific Title | Study for efficacy and safety of robot-assisted radical cystectomy using Da Vinci surgical system |
| Date of disclosure of the study information | 2015/09/24 |
| Last modified on | 2020/03/23 10:17:03 |
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Basic information
Public title
Study for efficacy and safety of robot-assisted radical cystectomy using Da Vinci surgical system
Acronym
Efficacy and safety of RARC
Scientific Title
Study for efficacy and safety of robot-assisted radical cystectomy using Da Vinci surgical system
Scientific Title:Acronym
Efficacy and safety of RARC
Region
| Japan |
Condition
Condition
Patients with invasive bladder cancer or those equivalent cancer who are undergoing radical cystectomy
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Duration of surgery, blood loss, surgical complications, histology of surgical specimens, and postoperative outcome will be evaluated for assessment of utility and safety of robot-assisted radical cystectomy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Duration of surgery, blood loss, perioperative and postoperative complications, histology of surgical specimen
Key secondary outcomes
Recurrent free survival, overall survival
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 | Maneuver |
Interventions/Control_1
Radical cystectomy and pelvic lymph node dissection will be performed by full robot-assisted procedure using Da Vinci surgical system. Urinary diversion will be performed by extracorporeal procedure.
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
Diagnosed as bladder cancer by histological examination
Clinical stage of T2-3N0M0 or BCG resistant TisN0M0
Informed consent is obtained from the patient
Key exclusion criteria
Active other malignancy
History of lower abdominal surgery
Severe heart disease
Severe hepatic disease
Anti-coagulant therapy cannot stop
Sever obesity such as BMI > 35
Patients without informed consent
Any other reasons inappropriate for this study
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Toru |
| Middle name | |
| Last name | Shimazui |
Organization
Ibaraki Prefectural Central Hospital
Division name
Department of Urology
Zip code
309-1793
Address
6528 Koibuchi, Kasama, Ibaraki 309-1793, Japan
TEL
0296-77-1121
torushim@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Yamauchi |
Organization
Ibaraki Prefectural Central Hospital
Division name
Department of Urology
Zip code
309-1793
Address
6528 Koibuchi, Kasama, Ibaraki 309-1793, Japan
TEL
0296-77-1121
Homepage URL
at-yamauchi@chubyoin.pref.ibaraki.jp
Sponsor or person
Institute
Ibaraki Prefectural Central Hospital
Institute
Department
Personal name
Funding Source
Organization
Ibaraki Prefectural Central Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of Ibaraki Prefectural Central Hospital
Address
6528 Koibuchi, Kasama, Ibaraki, Japan
Tel
0296-77-1121
h-oyama@chubyoin.pref.ibaraki.jp
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
| 2015 | Year | 09 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
5
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
Completed
Date of protocol fixation
| 2014 | Year | 12 | Month | 03 | Day |
Date of IRB
| 2014 | Year | 11 | Month | 26 | Day |
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 09 | Month | 17 | Day |
Last modified on
| 2020 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022035
