UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045100 |
|---|---|
| Receipt number | R000051502 |
| Scientific Title | The Southeast and East Asian Post-Operative Delirium (SEAPOD) Study |
| Date of disclosure of the study information | 2021/08/10 |
| Last modified on | 2021/08/09 13:50:38 |
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Basic information
Public title
The Southeast and East Asian Post-Operative Delirium (SEAPOD) Study
Acronym
SEAPOD Study
Scientific Title
The Southeast and East Asian Post-Operative Delirium (SEAPOD) Study
Scientific Title:Acronym
SEAPOD Study
Region
| Japan | Asia(except Japan) |
Condition
Condition
The hip fractured patients required surgical intervention
Classification by specialty
| Orthopedics | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The specific aim of the study will be to investigate the incidences and risk factors for postoperative delirium (POD) after hip fracture surgery in elderly patients aged over 65 years in five different Southeast and East Asian countries.
Basic objectives2
Others
Basic objectives -Others
1. To investigate factors in the hospital environments, such as noise levels, ambient lighting, nursing ratios, ward bedding and climate control, that contribute to similarities and/or differences in POD occurrences in different countries and health systems
2. To investigate patient factors, such as disease burden, mental health, education levels, and socioeconomic factors, that contribute to similarities and/or differences in POD occurrences in different countries and health systems
3. To quantify the direct and indirect costs, as well as resource utilization, resulting from the development of POD in each country
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Perioperative delirium is evaluated using NuDESC, 3D CAM.
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
1. Ability to provide informed consent
2. Elderly patients aged 65 years and above
3. Scheduled to undergo elective or emergency hip fracture surgery
Key exclusion criteria
1. History of psychiatric disease
2. Baseline cognitive impairment or dementia (MOCA score < 24)
3. Illiterate (unable to read or write with local language)
4. Active history of substance abuse
5. Has a second surgery planned within 5 days of index surgery
6. Has severe hearing or speaking disability
7. Has a plan to stay in ICU after operation
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Kotoe |
| Middle name | |
| Last name | Kamata |
Organization
Tohoku University School of Medicine
Division name
Department of Anesthesiology and Perioperative Medicine
Zip code
980-8575
Address
2-1 Seiryo-machi, Aoba-ku, Sendai-shi, Miyagi 980-8575, JAPAN
TEL
+81-22-717-7321
kotoe.kamata.c3@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Kotoe |
| Middle name | |
| Last name | Kamata |
Organization
Tohoku University School of Medicine
Division name
Department of Anesthesiology and Perioperative Medicine
Zip code
980-8575
Address
2-1 Seiryo-machi, Aoba-ku, Sendai-shi, Miyagi 980-8575, JAPAN
TEL
+81-22-717-7321
Homepage URL
kotoe.kamata.c3@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai-shi, Miyagi
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
| 2021 | Year | 08 | Month | 10 | 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
| 2021 | Year | 08 | Month | 03 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 05 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This observational study will be conducted at Tohoku University Hospital as part of the SEAPOD Study, an international collaborative study on postoperative delirium in Southeast and East Asia. The population will consist of patients aged 65 years or older who underwent hip fracture surgery at Tohoku University Hospital, and we will conduct an observational study of their preoperative, intraoperative, and postoperative status. The main purpose of this study is to identify the incidence of postoperative delirium and risk factors by comparing the results obtained at Tohoku University Hospital with those of other institutions in Southeast and East Asia.
Management information
Registered date
| 2021 | Year | 08 | Month | 09 | Day |
Last modified on
| 2021 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051502
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
