UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048123 |
|---|---|
| Receipt number | R000054844 |
| Scientific Title | Retrospective study on physical function of elderly people requiring emergency abdominal surgery |
| Date of disclosure of the study information | 2022/06/21 |
| Last modified on | 2022/06/21 14:54:45 |
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Basic information
Public title
Survey of physical function in elderly people and surgery
Acronym
S-PEAS Survey
Scientific Title
Retrospective study on physical function of elderly people requiring emergency abdominal surgery
Scientific Title:Acronym
S-PEAS Retrospective Study
Region
| Japan |
Condition
Condition
acute abdomen
Classification by specialty
| Surgery in general | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The number of elderly people who require emergency abdominal surgery is increasing, but there are a certain number of people whose physical function deteriorates after emergency surgery. In this survey, by examining items that can predict postoperative deterioration of physical function from preoperative general condition, it is useful for maintaining quality of life after surgery and for family and social care and welfare.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
physical functions, discharge destination, 30-day and 90-day survival prognosis
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent emergency abdominal surgery with a diagnosis of acute abdomen
Key exclusion criteria
Under 65 years old, exogenous disease, missing data
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Keishi |
| Middle name | |
| Last name | Yamaguchi |
Organization
Saiseikai Yokohamashi Tobu Hospital
Division name
Department of Trauma and Emergency Surgery
Zip code
230-0012
Address
3-6-1 Shimosueyoshi, Tsurumiku
TEL
045-576-3000
yamakei0218@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Keishi |
| Middle name | |
| Last name | Yamaguchi |
Organization
Saiseikai Yokohamashi Tobu Hospital
Division name
Department of Trauma and Emergency Surgery
Zip code
230-0012
Address
3-6-1 Shimosueyoshi, Tsurumiku
TEL
045-576-3000
Homepage URL
yamakei0218@yahoo.co.jp
Sponsor or person
Institute
Saiseikai Yokohamashi Tobu Hospital
Institute
Department
Personal name
Funding Source
Organization
NA
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
Yokohama City University Medical Center
Address
4-57 Urafunecho, Minamiku, Yokohama
Tel
045-261-5656
takeru-a@umin.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
| 2022 | Year | 06 | Month | 21 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 12 | Month | 13 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 13 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 13 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NA
Management information
Registered date
| 2022 | Year | 06 | Month | 21 | Day |
Last modified on
| 2022 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054844
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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