UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046740 |
|---|---|
| Receipt number | R000053271 |
| Scientific Title | A study to evaluate routine screening for deep vein thrombosis before surgery |
| Date of disclosure of the study information | 2022/01/27 |
| Last modified on | 2022/01/26 20:47:47 |
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Basic information
Public title
A study to evaluate routine screening for deep vein thrombosis before surgery
Acronym
RSDVT
Scientific Title
A study to evaluate routine screening for deep vein thrombosis before surgery
Scientific Title:Acronym
RSDVT
Region
| Japan |
Condition
Condition
Completed
Classification by specialty
| Surgery in general | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
evaluate screening deep venous thrombosis before surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
occurrence of pulmonary thromboembolism
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
surgical case
Key exclusion criteria
non-surgical case
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Endoh |
Organization
Saku Central Hospital Advanced Care Center
Division name
Thoracic Surgery
Zip code
385-0051
Address
3400-28 Nakagomi, Saku, Nagano
TEL
0267-62-8181
hidend0509@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Endoh |
Organization
Saku Central Hospital Advanced Care Center
Division name
Thoracic Surgery
Zip code
3850051
Address
3400-28, Nakagomi, Saku, Nagano
TEL
0267-62-8181
Homepage URL
hidend0509@yahoo.co.jp
Sponsor or person
Institute
Saku Central Hospital
Institute
Department
Personal name
Funding Source
Organization
Saku Central Hospital
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
Saku central Hospital Advanced Care Center
Address
3400-28 Nakagomi, Saku, Nagano
Tel
0267-62-8181
ctroffice@sakuhp.or.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 | 01 | Month | 27 | Day |
Related information
URL releasing protocol
217 patients were reported to have deep venous thrombosis
Publication of results
Unpublished
Result
URL related to results and publications
217 patients were reported to have deep venous thrombosis
Number of participants that the trial has enrolled
217
Results
217 patients were reported to have deep venous thrombosis.
Of the total 217 patients, all were managed using anti-embolism elastic stockings and 111 patients took anticoagulants.
No patient was developed with pulmonary thromboembolism.
Results date posted
| 2022 | Year | 01 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Not applicable
Participant flow
Not applicable
Adverse events
Not applicable
Outcome measures
Not applicable
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 17 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study that observed prognosis after surgery, results of ultra sound screening for deep venous thrombosis before and after surgery, and prevention method which selected by each surgeon without intervention.
Management information
Registered date
| 2022 | Year | 01 | Month | 26 | Day |
Last modified on
| 2022 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053271
