UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042453 |
|---|---|
| Receipt number | R000048463 |
| Scientific Title | Does emergency Orthopaedic surgery in the pandemic era increase the risk of developing COVID-19? A combined analysis of retrospective and prospective study at a national tertiary hospital in Jakarta, Indonesia |
| Date of disclosure of the study information | 2020/11/16 |
| Last modified on | 2020/11/14 10:28:10 |
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Basic information
Public title
Does emergency Orthopaedic surgery in the pandemic era increase the risk of developing COVID-19? A combined analysis of retrospective and prospective study at a national tertiary hospital in Jakarta, Indonesia
Acronym
Risk of developing COVID 19 in emergency Orthopaedic surgery
Scientific Title
Does emergency Orthopaedic surgery in the pandemic era increase the risk of developing COVID-19? A combined analysis of retrospective and prospective study at a national tertiary hospital in Jakarta, Indonesia
Scientific Title:Acronym
Risk of developing COVID 19 in emergency Orthopaedic surgery
Region
| Asia(except Japan) |
Condition
Condition
The study was performed at the emergency department unit at a national tertiary hospital in Jakarta, Indonesia. Subjects were patients who underwent emergency orthopaedic surgeries from April to May 2020.
Classification by specialty
| Medicine in general | Orthopedics | Adult |
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the relationship of emergency orthopaedic surgery and the incidence rate of COVID-19.
Basic objectives2
Others
Basic objectives -Others
Prognosis and risk
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Variables analyzed in this study includes age, gender, types of anaesthesia, duration of surgery, length of stay, clinical symptoms, and comorbidities. These variables were considered risk factors that may contribute to the development of COVID-19 infection.
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
| 2 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Subjects were patients who underwent emergency orthopaedic surgeries at our institution from April to May 2020.
Key exclusion criteria
Those who were previously infected with COVID-19 from polymerase chain reaction (PCR) reverse transcriptase (RT) examination obtained via nasopharynx and oropharynx swab were excluded from the study.
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | Achmad |
| Middle name | Fauzi |
| Last name | Kamal |
Organization
Faculty of Medicine, Universitas Indonesia, Cipto Mangunkusumo Hospital, Jakarta, Indonesia
Division name
Department of Orthopaedics and Traumatology
Zip code
10430
Address
Jl. Pangeran Diponegoro No.71, RW.5, Kenari, Kec. Senen, Kota Jakarta Pusat, Daerah Khusus Ibukota Jakarta 10430
TEL
+6281511450189
fauzikamal@yahoo.com
Public contact
Name of contact person
| 1st name | I Wayan Arya Mahendra |
| Middle name | |
| Last name | Karda |
Organization
Faculty of Medicine, Universitas Indonesia, Cipto Mangunkusumo Hospital, Jakarta, Indonesia
Division name
Department of Orthopaedics and Traumatology
Zip code
10430
Address
Jl. Pangeran Diponegoro No.71, RW.5, Kenari, Kec. Senen, Kota Jakarta Pusat, Daerah Khusus Ibukota J
TEL
+6287788408163
Homepage URL
arya961mahendra@gmail.com
Sponsor or person
Institute
Faculty of Medicine, Universitas Indonesia, Cipto Mangunkusumo Hospital, Jakarta, Indonesia
Institute
Department
Personal name
Funding Source
Organization
Faculty of Medicine, Universitas Indonesia, Cipto Mangunkusumo Hospital, Jakarta, Indonesia
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
The Ethics Committee of the Faculty of Medicine, University of Indonesia - Cipto Mangunkusumo Hospital
Address
Gedung Fakultas Kedokteran UI JI. Salemba Raya No.6, Jakarta 10430 PO.Box 1358
Tel
+62213912477
humas@fk.ui.ac.id
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
| 2020 | Year | 11 | Month | 16 | 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
14
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
| 2020 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 16 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This was a combined retrospective and prospective study. The study was performed at the emergency department unit at a national tertiary hospital in Jakarta, Indonesia. Subjects were patients who underwent emergency orthopaedic surgeries from April to May 2020. Variables analyzed in this study include age, gender, clinical symptoms, comorbidities, types of anaesthesia, duration of surgery, and length of stay. Physical examination, laboratory testing (routine blood test and differential blood count), and plain x-ray of the thorax were done to evaluate the outcome.
Management information
Registered date
| 2020 | Year | 11 | Month | 14 | Day |
Last modified on
| 2020 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048463
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