COVID-19 and mortality in surgical patients
| ISRCTN | ISRCTN97118839 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN97118839 |
| Secondary identifying numbers | M221055 MED-09-108 HREC University of the Witwatersrand |
- Submission date
- 14/02/2024
- Registration date
- 17/06/2024
- Last edited
- 17/06/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English Summary
Background and study aims
Surgical deaths may be preventable, potentially preventable or non-preventable. A preventable death is a death that should not have occurred regardless of the setting or resources whereas a potentially preventable death would not have happened if the situation was ideal. Factors that contribute to preventable or potentially preventable mortalities in surgical patients include medication errors, treatment delay, error of judgement, training issues, lack of supervision, shortage of resources and patient factors. Non-preventable deaths include deaths due to advanced cancer or severe traumatic brain injury. Around 5-15% of surgical deaths are preventable. The COVID-19 pandemic led to limitations in access to healthcare facilities and delays in the initiation of treatment. COVID-19 affects the outcomes of patients receiving surgery. Globally, it is evident that COVID-19 infection increases surgical death rates. Evidence from a recent study performed internationally illustrated that COVID-19-positive patients requiring surgery had an 18.9% risk of in-hospital mortality compared to COVID-19-negative patients where a 3.6% risk for IHM was reported. The study investigates how COVID-19 influences the preventability of surgical deaths and the contributing factors.
Who can participate?
Records of surgical patients who died during the period of study
What does the study involve?
The study involved the analysis of records of surgical patients who were admitted and died during the period of the COVID-19 pandemic from 01/03/2020 to 31/03/2020.
What are the possible benefits and risks of participating?
There were no benefits to the patients and potential risks included potential violation of privacy as the study dealt with medical records. However, data was de-identified and anonymized.
Where is the study run from?
Charlotte Maxeke Johannesburg Academic Hospital (South Africa)
When is the study starting and how long is it expected to run for?
March 2020 to November 2023
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Thifhelimbilu Luvhengo, thifheliluvhengo@gmail.com or thifhelimbilu.luvhengo@wits.ac.za
Contact information
Public, Scientific, Principal Investigator
Charlotte Maxeke Johannesburg Academic Hospital
Department of Surgery
Johannesburg
2193
South Africa
| Phone | +27 (0)839952552 |
|---|---|
| thifhelimbilu.luvhengo@wits.ac.za |
Study information
| Study design | Retrospective observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Treatment, Efficacy |
| Scientific title | The impact of COVID-19 infection on surgical mortality in Johannesburg, South Africa |
| Study acronym | COVID-19 Surg Mortalities |
| Study hypothesis | The study was observational. The rationale was to investigate if COVID-19 led to an increase in preventable surgical mortalities. |
| Ethics approval(s) |
Approved 24/04/2023, Human Research Ethics Committee (Medical) University of the Witwatersrand (3rd Floor, Room 306, Philip Tobias Building, Cnr York Road and Princess of Wales Terrace, Faculty of Health Sciences, Parktown, Johannesburg, 2193, South Africa; +27 (0)117171252; Iain.Burns@wits.ac.za), ref: M221055 MED-09-108 |
| Condition | Surgical mortality during the COVID-19 pandemic |
| Intervention | The study involved the analysis of records of surgical patients who were admitted and died during the period of the COVID-19 pandemic from 01/03/2020 to 31/03/2020. |
| Intervention type | Other |
| Primary outcome measure | The rate of occurrence of preventable mortalities among surgical patients who died during admission measured using data collected from medical records over 2 years from the 1st March 2020 to 31st March 2022 |
| Secondary outcome measures | Factors that contributed to preventable surgical mortalities measured using data collected from medical records over 2 years from the 1st March 2020 to 31st March 2022 |
| Overall study start date | 01/03/2020 |
| Overall study end date | 30/11/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 90 Years |
| Sex | Both |
| Target number of participants | 438 |
| Participant inclusion criteria | All patients who were admitted to the surgical department and died in hospital during the study period |
| Participant exclusion criteria | Patients whose final diagnosis at death was not surgical |
| Recruitment start date | 25/04/2023 |
| Recruitment end date | 01/11/2023 |
Locations
Countries of recruitment
- South Africa
Study participating centre
Johannesburg
2193
South Africa
Sponsor information
University/education
Charlotte Maxeke Johannesburg Academic Hospital
Department of Surgery
Johannesburg
2193
South Africa
| Phone | +27 (0)117172080 |
|---|---|
| Dyanadree.Subroyen@wits.ac.za | |
| Website | http://www.wits.ac.za/ |
"ROR" |
https://ror.org/03rp50x72 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 30/04/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | We plan to present the results at international research conferences and to publish the work in a high-impact peer-reviewed journal. |
| IPD sharing plan | The dataset generated and analyzed during the research will be made available on request with the prior permission of the local ethics committee by Thifhelimbilu Luvhengo (thifhelimbilu.luvhengo@wits.ac.za). The type of data that will be shared: Excel spreadsheet of results. Dates of availability: When it is requested and after obtaining permission from the local ethics committee. Whether consent from participants was required and obtained: The study did not require consent from participants as it was an audit based on records of departmental weekly morbidity and mortality records. Comments on data anonymization: Data was anonymized after extraction. All patient’s identifiers were removed. Any ethical or legal restrictions: Data can only be shared after receipt of ethical approval. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 28/02/2023 | 20/02/2024 | No | No |
Additional files
Editorial Notes
20/02/2024: Study's existence confirmed by the Human Research Ethics Committee (Medical) University of the Witwatersrand.
