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

Covid19 Clinical Trial

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

Status Not yet recruiting

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Postoperative Complications

• NCT number: NCT05052021
• Study type: Observational
• Source: Sefako Makgatho Health Sciences University
• Contact: Hyla-Louise Kluyts, DMed
• Phone: 27836803839
• Email: hyla.kluyts@smu.ac.za
• Status: Not yet recruiting
• Start date: September 2021
• Completion date: December 2023