The South African Coronavirus Disease of 2019 (COVID-19) Surgical Outcomes Study

Covid19 Clinical Trial

— SACSOS  

Official title:

The South African COVID-19 Surgical Outcomes Study - A Prospective Observational Cohort Study of Long-term Patient-reported Outcomes After Surgery Using a Digital Health Platform

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05052021
• Other study ID #: SMUREC/M/184/2020
• Status: Not yet recruiting
• Start date: September 2021
• Est. completion date: December 2023

Study information

• Verified date: September 2021
• Source: Sefako Makgatho Health Sciences University
• Contact: Hyla-Louise Kluyts, DMed
• Phone: 27836803839
• Email: hyla.kluyts[@]smu.ac.za
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The infectious coronavirus disease of 2019 (COVID-19), caused by corona virus SARS-severe acute respiratory syndrome corona virus 2 (SARS-CoV-2) has caused significant disruption in surgical services to patients globally. Data from the COVIDSurg Cohort Study suggest mortality rates of patients infected with SARS-Cov-2 in the peri-operative period of up to 25.6% in emergency surgery and 18.9% in elective surgery. Based on estimates by the COVIDSurg Collaborative, large numbers of elective surgical procedures are cancelled. The COVID-19 pandemic has forced healthcare providers to 'shift from patient-centred ethics to public health ethics'. This has had impact on pre-operative testing for COVID-19, and scheduling of surgery. Currently, a provisional recommendation to delay surgery for at least four weeks after a positive COVID test, exists. Weighing the risk of surgery and potential complications during the COVID-19 pandemic, against the benefit of undergoing a surgical procedure to improve quality of life, remains difficult. A study to determine the long term effect of the pandemic on patient-reported outcome may provide guidance on how to safely return to surgical activity that are again more focused on individualized care. There is also the opportunity to record outcomes that are currently accepted as the standard for understanding longer term recovery after surgery.

Description:

SACSOS is a patient-centered prospective observational cohort study. Initially, clinical teams in the South African private health care sector will be approached. In later phases of the study, recruitment will include eligible patients in the South African public health care sector. Patient engagement and -participation will be sought during the recruitment process by engaging with the clinical team (surgeon, anaesthetist, hospital clinical manager) for individual patient care (at a micro level); in data collection using a patient-centric platform; and in the follow up after surgery. Participation from health care providers will be in a team-based approach, including a surgeon, an anaesthetist and the hospital manager at each specific center. A call for collaboration will be extended to hospital management groups, individual hospital managers, and professional surgical and anaesthesia societies. A core group of participating centers may be identified which provide surgical services in provinces with highest number of apparent COVID-19 transmission at the time. The study will focus on patient participation with the web-based platform as the primary recruitment method. This will reduce the need for clinician input, and promote greater patient-centeredness. Patient participation and data capturing require internet access to the web-based platform. The dataset is based on variables collected during the first COVIDSurg study. The data collected will include a patient perspective on urgency of surgery during the pandemic, and quality of life measures.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: December 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients presenting for any surgical procedure at South African hospitals during the specified study period.

Exclusion Criteria:

• Patients unable to provide consent to participation.
• Patients whose legal guardian is unable to provide consent to participation (if applicable).
• Patients unable to nominate next-of-kin, guardian of or a person of their choice, as their representative during follow-up.

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Postoperative Complications

Intervention

Other:
• Recent or Peri-Operative Covid19 Infection
No intervention will be done. The groups will be differentiated based on whether they had recent or peri-operative Covid19 infection (group 1), or whether they have had no or previous Covid19 infection (Group 2)

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Sefako Makgatho Health Sciences University	Medical Research Council, South Africa, University of Cape Town

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life using EQ-5D-5L (terminology for the descriptive system) score	The questionnaire provides a simple descriptive profile of a respondent's health state.	6 Months post-operatively
Primary	Quality of Life using EQ-5D-5L (terminology for the descriptive system) score	The questionnaire provides a simple descriptive profile of a respondent's health state.	12 Months post-operatively
Secondary	In-Hospital Mortality	Mortality while admitted to hospital	30 days postoperatively
Secondary	30 Day Mortality	Mortality at 30 Days	30 days
Secondary	In-Hospital Post-Operative Morbidity	Using the Peri-Operative Morbidity Survey (POMS)	30 days
Secondary	30 Day Post-Operative Morbidity	Using the Peri-Operative Morbidity Survey (POMS)	30 days post-operatively
Secondary	Post-Operative Intensive Care Unit Length of Stay	Admission to Intensive Care for any reason post-operatively. Distinguishing between planned and unexpected ICU admissions.	30 days postoperatively
Secondary	Post-Operative Hospital Length of Stay	Total duration of admission, including days admitted to Intensive Care Unit or High Care Unit and days admitted to ward.	30 days postoperatively
Secondary	Quality of Recovery	Using the Quality of Recovery 15 (QoR15) Scale.	24-48 hours Post-Operatively
Secondary	Covid19 Diagnosis	Any patient reported diagnosis of Covid19.	30 days post-operatively
Secondary	Post-Operative Complications	Post-Operative complications reported by patient or physician.	30 days post-operatively
Secondary	Readmission to Hospital	Readmission for any reason	30 days post-operatively
Secondary	Days Alive and Out of Hospital (DAOH)	Standardised patient-centered outcome measure, evaluating number of days alive and out of hospital.	30 days post-operatively
Secondary	Functional status	Using the WHO Disability Assessment Score (WHODAS)	6 months post-operatively
Secondary	Functional status	Using the WHO Disability Assessment Score (WHODAS)	12 months post-operatively
Secondary	Hospital Cost	As reported by hospital manager	30 days postoperatively

External Links

•   Website for Safe Surgery South Africa. Surgery South Africa, a non-profit company (NPC) will act as custodian of data captured using the Perioperative Shared Health Record (PSHR) platform.