UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038785 |
|---|---|
| Receipt number | R000044173 |
| Scientific Title | Diagnostic accuracy of physical examination to detect the pelvic fractures among the blunt trauma patients; systematic review and meta-analysis |
| Date of disclosure of the study information | 2019/12/31 |
| Last modified on | 2021/02/18 07:39:52 |
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Basic information
Public title
Diagnostic accuracy of physical examination to detect the pelvic fractures among the blunt trauma patients; systematic review and meta-analysis
Acronym
Diagnostic accuracy of physical examination to detect the pelvic fractures among the blunt trauma patients; systematic review and meta-analysis
Scientific Title
Diagnostic accuracy of physical examination to detect the pelvic fractures among the blunt trauma patients; systematic review and meta-analysis
Scientific Title:Acronym
Diagnostic accuracy of physical examination to detect the pelvic fractures among the blunt trauma patients; systematic review and meta-analysis
Region
| Japan |
Condition
Condition
Pelvic fracture
Classification by specialty
| Emergency medicine | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Our study aim is to perform systematic review and meta-analysis to identify the diagnostic accuracy of physical examination for pelvic fracture among the blunt trauma patients.
Basic objectives2
Others
Basic objectives -Others
systematic review and meta-analysis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
summary receiver operating characteristic (SROC) and sensitivity and specificity
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
We will include all reports on the diagnostic accuracy of physical examinations for detecting pelvic fractures. We will include the studies designed as prospective or retrospective observational (cohort or cross-sectional) studies, or secondary analysis of randomized controlled trials.
Key exclusion criteria
We will exclude diagnostic case control studies. We will exclude case studies that did not provide sufficient diagnostic test accuracy data
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Okada |
| Middle name | |
| Last name | Yohei |
Organization
Graduate school of medicine, Kyoto Univerisity
Division name
Emergency and primary care medicine
Zip code
6068507
Address
ShogoinKawaramchi54
TEL
+81757513111
yokada-kyf@umin.ac.jp
Public contact
Name of contact person
| 1st name | Okada |
| Middle name | |
| Last name | Yohei |
Organization
Graduate school of medicine, Kyoto Univerisity
Division name
Emergency and primary care medicine
Zip code
6068507
Address
ShogoinKawaramachi 54
TEL
+81757513111
Homepage URL
yokada-kyf@umin.ac.jp
Sponsor or person
Institute
Graduate school of medicine, Kyoto Univerisity
Institute
Department
Personal name
Funding Source
Organization
Graduate school of medicine, Kyoto Univerisity
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
None
Address
None
Tel
none
None
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
| 2019 | Year | 12 | Month | 31 | 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
49043
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
| 2019 | Year | 12 | Month | 31 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 10 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 10 | 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
Participants
The target participants are blunt trauma patients with potential pelvic injury.
Target condition
Target condition is pelvic fracture due to blunt trauma.
Setting
Any type of settings are included. (e.g., prehospital setting or emergency department)
Index test
The index test being investigated is physical examination for pelvic fracture.
Reference standard is X-ray or Computed tomography (CT) to confirm the target condition defined as fracture of pelvis (ilium, ischium, pubis, and sacral fractures) diagnosed by physician such as emergency physician, acute care surgeon, orthopedics or radiologist.
Management information
Registered date
| 2019 | Year | 12 | Month | 04 | Day |
Last modified on
| 2021 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044173
