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

2021年9月17日 更新者:Hyla-Louise Kluyts、Sefako Makgatho Health Sciences University

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

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.

研究概览

详细说明

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.

研究类型

观察性的

注册 (预期的)

1000

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

To enable a patient-centred approach, patients will be invited to participate in the study by a member of the clinical team responsible for their care. 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.

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
Perioperative or Recent Covid19 Infection

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.

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)
No or Previous Covid19 Infection

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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Quality of Life using EQ-5D-5L (terminology for the descriptive system) score
大体时间:6 Months post-operatively
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
大体时间:12 Months post-operatively
The questionnaire provides a simple descriptive profile of a respondent's health state.
12 Months post-operatively

次要结果测量

结果测量
措施说明
大体时间
In-Hospital Mortality
大体时间:30 days postoperatively
Mortality while admitted to hospital
30 days postoperatively
30 Day Mortality
大体时间:30 days
Mortality at 30 Days
30 days
In-Hospital Post-Operative Morbidity
大体时间:30 days
Using the Peri-Operative Morbidity Survey (POMS)
30 days
30 Day Post-Operative Morbidity
大体时间:30 days post-operatively
Using the Peri-Operative Morbidity Survey (POMS)
30 days post-operatively
Post-Operative Intensive Care Unit Length of Stay
大体时间:30 days postoperatively
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
大体时间:30 days postoperatively
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
大体时间:24-48 hours Post-Operatively
Using the Quality of Recovery 15 (QoR15) Scale.
24-48 hours Post-Operatively
Covid19 Diagnosis
大体时间:30 days post-operatively
Any patient reported diagnosis of Covid19.
30 days post-operatively
Post-Operative Complications
大体时间:30 days post-operatively
Post-Operative complications reported by patient or physician.
30 days post-operatively
Readmission to Hospital
大体时间:30 days post-operatively
Readmission for any reason
30 days post-operatively
Days Alive and Out of Hospital (DAOH)
大体时间:30 days post-operatively
Standardised patient-centered outcome measure, evaluating number of days alive and out of hospital.
30 days post-operatively
Functional status
大体时间:6 months post-operatively
Using the WHO Disability Assessment Score (WHODAS)
6 months post-operatively
Functional status
大体时间:12 months post-operatively
Using the WHO Disability Assessment Score (WHODAS)
12 months post-operatively
Hospital Cost
大体时间:30 days postoperatively
As reported by hospital manager
30 days postoperatively

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Bruce Biccard, PhD、University of Cape Town
  • 首席研究员:Hyla-Louise Kluyts, DMed、Sefako Makgatho Health Sciences University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (预期的)

2021年9月1日

初级完成 (预期的)

2023年9月1日

研究完成 (预期的)

2023年12月1日

研究注册日期

首次提交

2021年9月14日

首先提交符合 QC 标准的

2021年9月17日

首次发布 (实际的)

2021年9月22日

研究记录更新

最后更新发布 (实际的)

2021年9月22日

上次提交的符合 QC 标准的更新

2021年9月17日

最后验证

2021年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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