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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000042453
Receipt No. 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

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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
Email 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
Email arya961mahendra@gmail.com

Sponsor
Institute Faculty of Medicine, Universitas Indonesia, Cipto Mangunkusumo Hospital, Jakarta, Indonesia
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048463

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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