The South African Coronavirus Disease of 2019 (COVID-19) Surgical Outcomes Study (SACSOS)
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
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
注册 (预期的)
联系人和位置
学习联系方式
- 姓名:Hyla-Louise Kluyts, DMed
- 电话号码:27836803839
- 邮箱:hyla.kluyts@smu.ac.za
研究联系人备份
- 姓名:Charle Steyl, FCA
- 电话号码:27848000904
- 邮箱:201710494@swave.smu.ac.za
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
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
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
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
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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