UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021704 |
|---|---|
| Receipt number | R000024493 |
| Scientific Title | Prospective observational study for peri operative rare complication |
| Date of disclosure of the study information | 2016/04/01 |
| Last modified on | 2016/03/21 12:53:36 |
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Basic information
Public title
Prospective observational study for peri operative rare complication
Acronym
Prospective observational study for peri operative rare complication
Scientific Title
Prospective observational study for peri operative rare complication
Scientific Title:Acronym
Prospective observational study for peri operative rare complication
Region
| Japan |
Condition
Condition
all patients undergoing surgery
Classification by specialty
| Surgery in general | Anesthesiology | Operative medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
is there a reduction in perioperative complication ?
Basic objectives2
Others
Basic objectives -Others
survey for incidence rate
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
an incidence of perioperative rare complication
Key secondary outcomes
perioperative variables affecting the rate of PORC
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
All patients recieving medical care in perioperative center in our hospital
Key exclusion criteria
patients who refused to participate in the study
Target sample size
12000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiko Kawaguchi |
Organization
Nara Medical University
Division name
Department of Anesthesiology
Zip code
Address
840 Shijo-cho, Kashihara, Nara, Japan
TEL
+81-(0)744-22-3051
drjkawa@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yusuke Naito |
Organization
Nara Medical University
Division name
Department of Anesthesiology
Zip code
Address
840 Shijo-cho, Kashihara, Nara, Japan
TEL
+81-(0)744-22-3051
Homepage URL
schneider.yusuke@gmail.com
Sponsor or person
Institute
Department of Anesthesiology, Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, Nara Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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
奈良県立医科大学付属病院（奈良）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | 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
| 2016 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2019 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 31 | Day |
Other
Other related information
Prospective Observational Study.
Patient is recruited when he/she appears to perioperative center in our hospital
Management information
Registered date
| 2016 | Year | 03 | Month | 31 | Day |
Last modified on
| 2016 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024493
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
