UMIN-CTR Clinical Trial

Basic information
Public title	Orthopaedic Surgery in The Pandemic Era
Acronym	Orthopaedic Surgery in The Pandemic Era
Scientific Title	Does elective 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	Does elective 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
Region	Asia(except Japan)

Condition
Condition	Subjects were patients who underwent elective orthopaedic surgeries at our institution from April to May 2020
Classification by specialty	Medicine in general Infectious disease Orthopedics
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	This study aims to investigate whether elective orthopaedic surgery will increase the risk of developing COVID-19
Basic objectives2	Others
Basic objectives -Others	to investigate whether elective orthopaedic surgery will increase the risk of developing COVID-19
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Variables analysed in this study includes age, gender, types of anaesthesia, duration of surgery, length of stay, clinical symptoms, smoking status, comorbidities, any history of visitation to pandemic countries, and any frequent contact with COVID-19-positive patients. These variables are considered risk factors that may contribute to the development of COVID-19
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Subjects were patients who underwent elective 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, as well as those who were reluctant to participate, were excluded from the study.
Target sample size	35

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	Universitas Indonesia
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Outside Japan
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 10 Month 30 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	35
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 16 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 05 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Variables analysed in this study includes age, gender, types of anaesthesia, duration of surgery, length of stay, clinical symptoms, smoking status, comorbidities, any history of visitation to pandemic countries, and any frequent contact with COVID-19-positive patients. These variables are considered risk factors that may contribute to the development of COVID-19. Patients who were eligible for elective surgery were examined preoperatively by laboratory testing (routine blood test and differential blood count) and plain chest radiograph. The patients also underwent COVID-19 screening by SARS CoV-2 Immunoglobulin G & IgM antibody test using 2019-nCoV IgG/IgM Detection Kit

Management information
Registered date	2020 Year 10 Month 08 Day
Last modified on	2020 Year 10 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047986