UMIN-CTR Clinical Trial

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