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

17 septembre 2021 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

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

Observationnel

Inscription (Anticipé)

1000

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

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

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

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

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

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

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Anticipé)

1 septembre 2021

Achèvement primaire (Anticipé)

1 septembre 2023

Achèvement de l'étude (Anticipé)

1 décembre 2023

Dates d'inscription aux études

Première soumission

14 septembre 2021

Première soumission répondant aux critères de contrôle qualité

17 septembre 2021

Première publication (Réel)

22 septembre 2021

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

22 septembre 2021

Dernière mise à jour soumise répondant aux critères de contrôle qualité

17 septembre 2021

Dernière vérification

1 septembre 2021

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

INDÉCIS

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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