Surgery Clinical Trial
Official title:
African Surgical OutcomeS-2 (ASOS-2) Trial
An international, multicentre, African cluster randomised trial.
Primary objective :
To determine whether increased postoperative surveillance in high-risk adult surgical
patients reduces overall in-hospital mortality in surgical patients aged 18 years and over in
Africa.
Primary outcome measure:
In-hospital mortality, censored at 30 days if the patient is still alive and in-hospital.
Secondary objective:
To determine whether increased postoperative surveillance in high-risk adult surgical
patients reduces the overall incidence of the composite of severe in-hospital complications
and mortality in adult surgical patients aged 18 years and over in Africa.
Secondary outcome measure:
Composite of severe in-hospital complications and mortality, censored at 30 days if the
patient is still alive and in-hospital.
Study design:
ASOS-2 is an African, international, multicentre, cluster randomised trial.
Inclusion criteria:
- Patients: All consecutive adult patients aged 18 years and over admitted to
participating centres undergoing elective and non-elective surgery
- Participating surgical centres: Randomised according to a stratification based upon the
level of the surgical facility and the surgical case load. Recruitment will start in May
2019.
Exclusion criteria:
*Prior participation in ASOS-2
Recruitment and screening:
This is a pragmatic trial. It is an African, international cluster randomised controlled
trial in several African countries. Participating surgical sites will be randomised to either
increased postoperative surveillance or usual postoperative care. The investigators expect
all consecutive adult patients aged 18 years and over admitted to participating centres
undergoing elective and non-elective surgery to be included in the trial. 'Broadcasting'
through appropriate hospital notices and signage will inform the patients and the public that
the hospital is participating in the cluster randomised trial.
Ethics approval:
The requirement for patient consent is expected to vary according to regulations of the
participating nations. The national leaders will ensure ethics approval is obtained from
their respective countries and centres. Centres will not be permitted to record data unless
ethics approval or an equivalent waiver is in place.
Randomisation:
Participating sites will be randomised to normal postoperative care, or increased
postoperative surveillance. Randomisation will be stratified according to the level of the
surgical facility and the expected weekly surgical case-load.The investigators plan to
randomise 664 hospitals to either increased postoperative surveillance or standard care for
high-risk adult (≥18 years) surgical patients. The follow up is in-hospital.
Trial intervention:
The intervention arm to which each participating site is randomised will be offered to all
eligible surgical patients for the duration of the trial.
Intervention arm:
Participating sites which have been randomised to increased surveillance will need to provide
increased surveillance to surgical patients with a predicted increased postoperative risk as
determined by the ASOS risk stratification tool. Increased postoperative surveillance can
include either of the following; i) admission to a higher care ward than had been planned at
the time of surgery, ii) an increase in the frequency of nursing observations in the
postoperative period, iii) ensuring that the patient is placed in view of the nursing
station, and not in a remote location in the postoperative ward, or iv) allowing family
members to stay with the patient in the ward in the postoperative period. The nature of the
offered increased postoperative surveillance will be left to the discretion of the healthcare
workers and the participating sites. However, all sites will be encouraged to include more
than one of the increased postoperative surveillance intervention. The healthcare providers
will also receive information on the leading causes of postoperative mortality in African
surgical patients as documented in ASOS; surgical site infections, bloodstream infection and
acute respiratory distress syndrome, pneumonia, acute kidney injury, postoperative bleeding,
and cardiac arrest. This will be known as the 'Postoperative surveillance bedside guide' and
will be placed at the bedside of every patient flagged as high-risk by the ASOS Surgical Risk
Calculator. This should be placed in a visible position at the patient's bedside e.g. posted
on the wall above the patient's bed.
Control arm:
Participating sites randomised to the control arm will provide usual postoperative care to
patients. The care will be left to the discretion of the healthcare providers.
Data collection and collation:
Centre specific data will be collected once for each hospital including: university or
non-university hospital, number of hospital beds, number of operating rooms, number and level
of critical care beds and details about the reimbursement status of the hospital. An ASOS-2
case record form (CRF) will be completed for every eligible patient who undergoes surgery
during the trial. Patients will be followed up until hospital discharge. This will be
censored at thirty days i.e. patients will be followed up until discharge or for thirty days
whichever is the shorter period.
Follow up procedures:
Follow-up data will be collected by a site trial investigator. Investigators will review a
participant's in-hospital medical records (paper or electronic) up to hospital discharge.
Sample size calculation:
This is a cluster randomised trial of hospitals in Africa. The investigators will match
hospitals on expected surgical volume in a week of surgery. This varied tremendously across
the ASOS group; with a median number of surgical procedures per hospital for the study week
in ASOS of 29 (IQR 10-71). The variability of the individual patient outcomes explained by
the cluster (or surgical site) is taken into account in these sample size calculations. The
inter-cluster correlation coefficient (ICC) in ASOS was 0.01. For the sample size
calculation, the investigators have therefore used a conservative ICC of 0.015.
Based on ASOS, the investigators estimate the coefficient of variance for a 4-week
recruitment period to be 0.63. A 4-week recruitment period is defined as the following; i)
hospitals stop recruiting at the end of the week in which they have exceeded 100 enrolled
patients, and ii) if a site had not reached 100 enrolled patients after 4 weeks of
recruiting, it would stop recruiting.
The incidence of mortality in ASOS was 2.1%. The investigators expect a 25% relative risk
reduction in mortality through increased surveillance of postoperative surgical patients at
high-risk of severe complications or in-hospital mortality. Based on the intra-cluster
correlation coefficient (ICC) for the composite of severe complications and mortality in
ASOS-2 of 1.5%, a coefficient of variance of 0.63, and stratification for the level of the
surgical facility, and the volume of procedures per week, a trial for efficacy of increased
postoperative surveillance would require 64,200 patients, from 642 surgical centres across
Africa.
Statistical analysis:
Outcomes will be presented at a continental level. All institutional level data will be
anonymised prior to publication. Categorical variables will be described as proportions and
will be compared using chi-square tests. Continuous variables will be described as mean and
standard deviation if normally distributed or median and inter-quartile range if not normally
distributed. Comparisons of continuous variables between groups will be performed using
t-tests, one-way ANOVA or equivalent non-parametric tests as appropriate.
The primary outcome will be in hospital mortality. Overall differences in in-hospital
mortality will be compared between the intervention and control clusters. All analyses will
account for clusters. A list of baseline risk factors (the risk factors in the ASOS Surgical
Risk Calculator) will be included in the analysis. The investigators will use logistic
regression model to estimate the effect of increased postoperative surveillance, on the
primary and secondary outcomes. The investigators will calculate the odds ratios and their
associated 95% confidence intervals. The investigators will infer statistical significance if
the computed 2-sided p-value is < 0.05. A single final analysis is planned at the end of the
study.
Subgroup analyses:
An a priori decision has been taken to conduct the following subgroup analyses; i) between
high- and low-outcome hospitals, ii) between district hospitals and higher-level hospitals,
iii) between low- and high-human resourced surgical hospitals, iv) between low-income
countries and middle-income countries, and v) between the different types of postoperative
surveillance.
Secondary studies: The use of the ASOS-2 Trial data for secondary studies will be encouraged.
Monitoring and auditing:
The Sponsor will have oversight of the trial conduct at each site. The trial team will take
day-to-day responsibility for ensuring compliance with the requirements of GCP in terms of
quality control and quality assurance of the data collected as well as safety reporting. The
ASOS-2 Trial Management Group will communicate closely with individual sites and the
Sponsor's representatives to ensure these processes are effective.
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