UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049365 |
|---|---|
| Receipt number | R000056185 |
| Scientific Title | Operative Management for Traumatic Chest Wall Injuries: A Systematic Review and Meta-analysis with Trial Sequential Analysis |
| Date of disclosure of the study information | 2022/11/01 |
| Last modified on | 2024/05/02 11:56:16 |
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Basic information
Public title
Operative management for traumatic chest wall injuries: a protocol for systematic review and meta-analysis with trial sequential analysis
Acronym
Operative Management for Traumatic Chest Wall Injuries
Scientific Title
Operative Management for Traumatic Chest Wall Injuries: A Systematic Review and Meta-analysis with Trial Sequential Analysis
Scientific Title:Acronym
Operative Management for Traumatic Chest Wall Injuries
Region
| Japan |
Condition
Condition
Traumatic Chest Wall Injuries
Classification by specialty
| Surgery in general | Chest surgery | Orthopedics |
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the effectiveness and safety of operative management for traumatic chest wall injuries
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Duration of mechanical ventilation
Key secondary outcomes
All-cause mortality, pneumonia, length of ICU stay, length of hospital stay, tracheostomy, quality of life including pain, spirometry
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Papers published until October 2022. Randomised controlled trials for operative versus non-operative management for traumatic multi-rib fractures
Patients; Either flail chest wall injuries or multiple (more than 3) rib fractures.
Intervention; Operative rib fracture fixation
Comparison; Non-operative management
Outcome; The duration of mechanical ventilation, all-cause mortality, pneumonia, length of stay in ICU, length of stay in the hospital, tracheostomy, quality of life including pain, spirometry
Key exclusion criteria
1) Systematic review or meta-analysis articles, retrospective analysis, non-RCT, single prospective cohort study without a control group, case reports, repeated reports.
2) Literature of very low quality.
3) Studies with research purpose or operation type differed from those defined in this study.
4) Two investigators independently screened all titles, abstracts, and full texts for eligibility. Final inclusion will be decided after resolving discrepancies between the two investigators.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Kazuma |
| Middle name | |
| Last name | Yamakawa |
Organization
Osaka Medical and Pharmaceutical University
Division name
Department of Emergency and Critical Care Medicine
Zip code
569-8686
Address
2-7 Daigakumachi, Takatsuki, Osaka, Japan
TEL
0726831221
kazuma.yamakawa@ompu.ac.jp
Public contact
Name of contact person
| 1st name | Kazuma |
| Middle name | |
| Last name | Yamakawa |
Organization
Osaka Medical and Pharmaceutical University
Division name
Department of Emergency and Critical Care Medicine
Zip code
569-8686
Address
2-7 Daigakumachi, Takatsuki, Osaka, Japan
TEL
0726831221
Homepage URL
kazuma.yamakawa@ompu.ac.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
Research grant program by the Japanese Society of Thrombosis and Haemostasis
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Medical and Pharmaceutical University
Address
2-7 Daigakumachi, Takatsuki, Osaka, Japan
Tel
0726831221
kazuma.yamakawa@ompu.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 | 11 | Month | 01 | 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
Completed
Date of protocol fixation
| 2022 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 30 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Systematic searching will be performed using three databases (Pubmed, Scopus, and Cochrane).
We will additionally analyze by trial sequential analysis. If we acquire sufficient data, we will perform subgroup analysis as heterogeneity analysis (age, sex, severity of trauma, with and without mechanical ventilation and lung contusion). Also, we will perform sensitivity analysis using low RoB trials.
Management information
Registered date
| 2022 | Year | 10 | Month | 29 | Day |
Last modified on
| 2024 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056185
| 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 |
