- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT05052021
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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Hyla-Louise Kluyts, DMed
- Numéro de téléphone: 27836803839
- E-mail: hyla.kluyts@smu.ac.za
Sauvegarde des contacts de l'étude
- Nom: Charle Steyl, FCA
- Numéro de téléphone: 27848000904
- E-mail: 201710494@swave.smu.ac.za
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
---|---|
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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Quality of Life using EQ-5D-5L (terminology for the descriptive system) score
Délai: 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
Délai: 12 Months post-operatively
|
The questionnaire provides a simple descriptive profile of a respondent's health state.
|
12 Months post-operatively
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
In-Hospital Mortality
Délai: 30 days postoperatively
|
Mortality while admitted to hospital
|
30 days postoperatively
|
30 Day Mortality
Délai: 30 days
|
Mortality at 30 Days
|
30 days
|
In-Hospital Post-Operative Morbidity
Délai: 30 days
|
Using the Peri-Operative Morbidity Survey (POMS)
|
30 days
|
30 Day Post-Operative Morbidity
Délai: 30 days post-operatively
|
Using the Peri-Operative Morbidity Survey (POMS)
|
30 days post-operatively
|
Post-Operative Intensive Care Unit Length of Stay
Délai: 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
Délai: 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
Délai: 24-48 hours Post-Operatively
|
Using the Quality of Recovery 15 (QoR15) Scale.
|
24-48 hours Post-Operatively
|
Covid19 Diagnosis
Délai: 30 days post-operatively
|
Any patient reported diagnosis of Covid19.
|
30 days post-operatively
|
Post-Operative Complications
Délai: 30 days post-operatively
|
Post-Operative complications reported by patient or physician.
|
30 days post-operatively
|
Readmission to Hospital
Délai: 30 days post-operatively
|
Readmission for any reason
|
30 days post-operatively
|
Days Alive and Out of Hospital (DAOH)
Délai: 30 days post-operatively
|
Standardised patient-centered outcome measure, evaluating number of days alive and out of hospital.
|
30 days post-operatively
|
Functional status
Délai: 6 months post-operatively
|
Using the WHO Disability Assessment Score (WHODAS)
|
6 months post-operatively
|
Functional status
Délai: 12 months post-operatively
|
Using the WHO Disability Assessment Score (WHODAS)
|
12 months post-operatively
|
Hospital Cost
Délai: 30 days postoperatively
|
As reported by hospital manager
|
30 days postoperatively
|
Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Bruce Biccard, PhD, University of Cape Town
- Chercheur principal: Hyla-Louise Kluyts, DMed, Sefako Makgatho Health Sciences University
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Anticipé)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Processus pathologiques
- Infections à coronavirus
- Infections à Coronaviridae
- Infections à Nidovirales
- Infections par virus à ARN
- Maladies virales
- Infections
- Infections des voies respiratoires
- Maladies des voies respiratoires
- Pneumonie virale
- Pneumonie
- Maladies pulmonaires
- COVID-19 [feminine]
- Complications postopératoires
Autres numéros d'identification d'étude
- SMUREC/M/184/2020
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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