UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047722 |
|---|---|
| Receipt number | R000054409 |
| Scientific Title | Comparison of importance of preoperative anesthesia difficulty factors affecting postoperative outcome |
| Date of disclosure of the study information | 2022/05/11 |
| Last modified on | 2023/05/11 09:19:50 |
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Basic information
Public title
Comparison of importance of preoperative anesthesia difficulty factors affecting postoperative outcome
Acronym
Comparison of importance of preoperative anesthesia difficulty factors affecting postoperative outcome
Scientific Title
Comparison of importance of preoperative anesthesia difficulty factors affecting postoperative outcome
Scientific Title:Acronym
Comparison of importance of preoperative anesthesia difficulty factors affecting postoperative outcome
Region
| Japan |
Condition
Condition
Elective surgery patients who died within 60 days after surgery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We will select patients who have difficulty in preoperative anesthesia and who died within 60 days and investigate which complications most affect outcome after surgery.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Select patients who have difficulty preoperative anesthesia and die within 60 days to investigate which preoperative complications have the greatest impact on postoperative outcomes
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Elective surgery patients who died within 60 days after surgery
Key exclusion criteria
emergency surgery
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | MAIKO |
| Middle name | |
| Last name | SATOMOTO |
Organization
toho University
Division name
Department of Anesthesiology
Zip code
1438541
Address
6-11-1. Omori-nishi, Ota-ku, Tokyo 143-8541, Japan
TEL
09034444882
maiko.satomoto@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | MAIKO |
| Middle name | |
| Last name | SATOMOTO |
Organization
Toho University
Division name
Department of Anesthesiology
Zip code
1438541
Address
6-11-1, Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan
TEL
0337654151
Homepage URL
maiko.satomoto@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University
Institute
Department
Personal name
Funding Source
Organization
Toho University, Department of Anesthesiology
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
Toho University Ethics Review Board
Address
6-11-1, Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan
Tel
0337624151
omori.rinri@ext.toho-u.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
東邦大学医療センター大森病院
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 05 | Month | 11 | 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
45
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
| 2020 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 22 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 11 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational Study
Management information
Registered date
| 2022 | Year | 05 | Month | 11 | Day |
Last modified on
| 2023 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054409
