UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018088 |
|---|---|
| Receipt number | R000020509 |
| Scientific Title | Renal function after fluid restriction during robotic-assisted laparoscopic radical prostatectomy. |
| Date of disclosure of the study information | 2015/07/01 |
| Last modified on | 2023/04/28 23:32:04 |
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Basic information
Public title
Renal function after fluid restriction during robotic-assisted laparoscopic radical prostatectomy.
Acronym
Renal function after robotic-assisted laparoscopic radical prostatectomy.
Scientific Title
Renal function after fluid restriction during robotic-assisted laparoscopic radical prostatectomy.
Scientific Title:Acronym
Renal function after robotic-assisted laparoscopic radical prostatectomy.
Region
| Japan |
Condition
Condition
prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Establish the fluid management during robotic-assisted laparoscopic radical prostatectomy not to damage renal function.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
preoperative vs postoperative day 7 serum creatinine level
Key secondary outcomes
serum creatinine level on postoperative day 1 and 2
postoperative urine output
postoperative airway edema
incidence of AKI based on KDIGO criteria
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
Key inclusion criteria
Patient who is undergoing robotic-assisted laparoscopic radical prostatectomy.
Key exclusion criteria
Patient who has disease which might give disadvantage by doing fluid restriction.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Hajime |
| Middle name | |
| Last name | Iwasaki |
Organization
Asahikawa Medical University
Division name
department of Anesthesiology and Critical Care Medicine
Zip code
0788510
Address
2-1-1-1 Midorigaoka-higashi, Asahikawa, Hokkaido, Japan
TEL
0166-68-2583
iwasakih@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | Hajime |
| Middle name | |
| Last name | Iwasaki |
Organization
Asahikawa Medical University
Division name
department of Anesthesiology and Critical Care Medicine
Zip code
0788510
Address
2-1-1-1 Midorigaoka-higashi, Asahikawa, Hokkaido, Japan
TEL
0166-68-2583
Homepage URL
iwasakih@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University
Institute
Department
Personal name
Funding Source
Organization
There is no funding.
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
Asahikawa Medical University Research Ethics Committee
Address
2-1-1-1 Midorigaoka-higashi, Asahikawa, Hokkaido, Japan
Tel
0166-66-1300
rs-kk.g@asahikawa-med.ac.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 | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
70
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
| 2015 | Year | 06 | Month | 25 | Day |
Date of IRB
| 2015 | Year | 02 | Month | 09 | Day |
Anticipated trial start date
| 2015 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective cohort study.
Management information
Registered date
| 2015 | Year | 06 | Month | 25 | Day |
Last modified on
| 2023 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020509
