UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047975 |
|---|---|
| Receipt number | R000054620 |
| Scientific Title | Risk factors of deep venous thrombosis after surgery: selective estrogen receptor modulators and postoperative rehabilitation |
| Date of disclosure of the study information | 2022/06/08 |
| Last modified on | 2025/06/12 17:23:17 |
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Basic information
Public title
Analysis of risk factors for deep venous thrombosis in patients after orthopedic surgery for the lower extremity in elderly female patients: The effect of selective estrogen receptor modulators and postoperative rehabilitation
Acronym
Risk factors of deep venous thrombosis after surgery: selective estrogen receptor modulators and postoperative rehabilitation
Scientific Title
Risk factors of deep venous thrombosis after surgery: selective estrogen receptor modulators and postoperative rehabilitation
Scientific Title:Acronym
Risk factors of deep venous thrombosis after surgery
Region
| Japan |
Condition
Condition
Elderly female patients undergoing orthopedic surgery for the lower extremity
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Survey of thrombosis during perioperative period
Basic objectives2
Others
Basic objectives -Others
None
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Thrombosis during perioperative period (seven days after surgery)
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
| 100 | years-old | > |
Gender
Female
Key inclusion criteria
Patients undergoing orthopedic surgery for lower extremity
Key exclusion criteria
None
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yukio |
| Middle name | |
| Last name | Hayashi |
Organization
Yoka Municipal Hospital
Division name
Anesthesiology
Zip code
6678555
Address
1878-1 Yoka, Yoka-cho, Yabu, 667-8555 Hyogo, JAPAN
TEL
0796625555
yhayashi@anes.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Yukio |
| Middle name | |
| Last name | Hayashi |
Organization
Yoka Municipal Hospital
Division name
Anesthesiology
Zip code
6678555
Address
1878-1 Yoka, Yoka-cho, Yabu, 667-8555 Hyogo, JAPAN
TEL
0796625555
Homepage URL
yhayashi@anes.med.osaka-u.ac.jp
Sponsor or person
Institute
Yoka Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
Yoka Municipal Hospital
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
None
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB, Yoka Municipal Hospital
Address
1878-1 Yoka, Yoka-cho, Yabu, 667-8555 Hyogo, JAPAN
Tel
0796625555
somu1@hosp.yoka.hyogo.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 | 08 | Day |
Related information
URL releasing protocol
Annual of Surgery and Perioperative Care 2025;10:1072
Publication of results
Partially published
Result
URL related to results and publications
Annual of Surgery and Perioperative Care 2025;10:1072
Number of participants that the trial has enrolled
201
Results
Dementia and emaciation are significant risk factors for deep venous thrombosis after orthopedic surgery for the lower extremity in elderly female patients.
Results date posted
| 2025 | Year | 06 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 06 | Month | 10 | Day |
Baseline Characteristics
Elderly female patients undergoing orthopedic surgery for lower extremity.
Participant flow
Annual of Surgery and Perioperative Care 2025;10:1072
Adverse events
None
Outcome measures
Deep venous thrombosis after surgery
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2022 | Year | 05 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 07 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 16 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 30 | Day |
Date trial data considered complete
| 2023 | Year | 12 | Month | 30 | Day |
Date analysis concluded
| 2025 | Year | 05 | Month | 31 | Day |
Other
Other related information
None
Management information
Registered date
| 2022 | Year | 06 | Month | 07 | Day |
Last modified on
| 2025 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054620
