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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Covid19, Postoperative Complications

Intervention / Treatment
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* Other: Recent or Peri-Operative Covid19 Infection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Perioperative or Recent Covid19 Infection<br>Patients will be classified as having Perioperative Covid19 Infection if they test positive for SARS-CoV-2 within 7 days before and 30 days after surgery. Patients will be classified as having Recent Covid19 infection if they tested positive for Covid19 within 1-6 weeks before surgery. These patients will be analysed together as a group, as it is likely that their risk for complications will be similar. | Other: Recent or Peri-Operative Covid19 Infection<br>* 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)<br>|
| No or Previous Covid19 Infection<br>Patients will be classified as having No Covid19 Infection if they have never tested positive for Covid19. Patients will be classified as having Previous Covid19 Infection when they tested positive for Covid19 infection 7 weeks or more before surgery. These patients will be analysed together as a group, as it is likely that their risk for complications will be similar. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-Hospital Mortality | Mortality while admitted to hospital | 30 days postoperatively | 
| 30 Day Mortality | Mortality at 30 Days | 30 days | 
| In-Hospital Post-Operative Morbidity | Using the Peri-Operative Morbidity Survey (POMS) | 30 days | 
| 30 Day Post-Operative Morbidity | Using the Peri-Operative Morbidity Survey (POMS) | 30 days post-operatively | 
| 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 | 
| 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 | 
| Quality of Recovery | Using the Quality of Recovery 15 (QoR15) Scale. | 24-48 hours Post-Operatively | 
| Covid19 Diagnosis | Any patient reported diagnosis of Covid19. | 30 days post-operatively | 
| Post-Operative Complications | Post-Operative complications reported by patient or physician. | 30 days post-operatively | 
| Readmission to Hospital | Readmission for any reason | 30 days post-operatively | 
| 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 | 
| Functional status | Using the WHO Disability Assessment Score (WHODAS) | 6 months post-operatively | 
| Functional status | Using the WHO Disability Assessment Score (WHODAS) | 12 months post-operatively | 
| Hospital Cost | As reported by hospital manager | 30 days postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Outcome measures, Peri-operative care, Patient-centered care, Cost Benefit Analysis