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
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Očekávaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Hyla-Louise Kluyts, DMed
- Telefonní číslo: 27836803839
- E-mail: hyla.kluyts@smu.ac.za
Studijní záloha kontaktů
- Jméno: Charle Steyl, FCA
- Telefonní číslo: 27848000904
- E-mail: 201710494@swave.smu.ac.za
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Quality of Life using EQ-5D-5L (terminology for the descriptive system) score
Časové okno: 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
Časové okno: 12 Months post-operatively
|
The questionnaire provides a simple descriptive profile of a respondent's health state.
|
12 Months post-operatively
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
In-Hospital Mortality
Časové okno: 30 days postoperatively
|
Mortality while admitted to hospital
|
30 days postoperatively
|
|
30 Day Mortality
Časové okno: 30 days
|
Mortality at 30 Days
|
30 days
|
|
In-Hospital Post-Operative Morbidity
Časové okno: 30 days
|
Using the Peri-Operative Morbidity Survey (POMS)
|
30 days
|
|
30 Day Post-Operative Morbidity
Časové okno: 30 days post-operatively
|
Using the Peri-Operative Morbidity Survey (POMS)
|
30 days post-operatively
|
|
Post-Operative Intensive Care Unit Length of Stay
Časové okno: 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
Časové okno: 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
Časové okno: 24-48 hours Post-Operatively
|
Using the Quality of Recovery 15 (QoR15) Scale.
|
24-48 hours Post-Operatively
|
|
Covid19 Diagnosis
Časové okno: 30 days post-operatively
|
Any patient reported diagnosis of Covid19.
|
30 days post-operatively
|
|
Post-Operative Complications
Časové okno: 30 days post-operatively
|
Post-Operative complications reported by patient or physician.
|
30 days post-operatively
|
|
Readmission to Hospital
Časové okno: 30 days post-operatively
|
Readmission for any reason
|
30 days post-operatively
|
|
Days Alive and Out of Hospital (DAOH)
Časové okno: 30 days post-operatively
|
Standardised patient-centered outcome measure, evaluating number of days alive and out of hospital.
|
30 days post-operatively
|
|
Functional status
Časové okno: 6 months post-operatively
|
Using the WHO Disability Assessment Score (WHODAS)
|
6 months post-operatively
|
|
Functional status
Časové okno: 12 months post-operatively
|
Using the WHO Disability Assessment Score (WHODAS)
|
12 months post-operatively
|
|
Hospital Cost
Časové okno: 30 days postoperatively
|
As reported by hospital manager
|
30 days postoperatively
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Bruce Biccard, PhD, University of Cape Town
- Vrchní vyšetřovatel: Hyla-Louise Kluyts, DMed, Sefako Makgatho Health Sciences University
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Očekávaný)
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- SMUREC/M/184/2020
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