Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT05934682 |
Other study ID # |
LASOS-Peds |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
December 20, 2023 |
Est. completion date |
February 1, 2025 |
Study information
Verified date |
November 2023 |
Source |
University of Sao Paulo |
Contact |
Vinicius Quintao, MD, PhD |
Phone |
+ 55 11 2661-5795 |
Email |
vinicius.quintao[@]hc.fm.usp.br |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
This prospective, international, multicenter observational study will include hospitals
performing pediatric surgery in participating Latin American countries.
We aim to assess the incidence of hospital postoperative complications in pediatric surgical
patients < 18-years-old in Latin America. We will recruit all consecutive pediatric patients
under the age of 18 years who were admitted to participating hospitals undergoing elective
and nonelective surgery. The primary outcome is in-hospital postoperative complications up to
30 days after surgery.
Description:
Background
Surgery is a cost-effective public health intervention. However, there are significant
disparities in access to and in the safety of surgical and anesthesia services in low- and
middle-income countries compared to high-income countries. (1) Additionally, there is a
significant burden of surgical disease in the pediatric surgical population with a
significant unmet need. (2,3) In Africa, children represent a significant proportion of the
population, with approximately 50% of the population aged <19 years; moreover, this
proportion is very similar in Latin America. (4) Postoperative complications are an important
determinant of surgical morbidity and mortality. Limited data from Africa and Latin America
suggest that risk factors, incidence, and outcomes associated with pediatric surgical
complications differ in high-income countries. In the South African Pediatric Surgical
Outcomes Study (SAPSOS), patients in this middle-income country (5) had twice the incidence
of complications (6-8), and the types of complications differed from those in high-income
countries, with a predominance of infectious complications. Furthermore, risk factors for
complications (including ASA physical status, urgent surgery, surgery severity, and
infectious indication for surgery) were different from those in high-income countries,
wherein the risk factors include post-conceptual age, ASA physical status > 3, history of
cardiovascular disease, and cardiovascular, neurological, or orthopedic surgical procedures.
(9) Postoperative mortality was observed to be ten times higher in
South Africa than in a prospective study in high-income countries. (10) Furthermore, a
prospective study of pediatric perioperative mortality in 24 Kenyan hospitals demonstrated a
7-day postoperative mortality of 1.7% (11), which is 17 times higher than that reported in
high-income countries.
The African Surgical Outcomes Study (ASOS) described surgical outcomes in African adult
patients. (12) Specifically, patients had a lower risk profile and fewer complications than
those in high-income countries. However, postoperative mortality was twice the global
average. A similar study is being performed in Latin America (LASOS), which also includes
adults.
It is necessary to determine the importance of complications in pediatric surgical patients
in Latin America, as well as the risk factors and types of complications that are experienced
by these patients, due to the fact that data on this population are scarce. Consequently, we
will be able to target appropriate interventions and funding to improve surgical outcomes for
children in Latin America.
Study objectives
Primary objective
To determine the incidence of in-hospital postoperative complications up to 30 days after
surgery in Latin American pediatric surgical patients (under 18-years-old).
Secondary objectives
In pediatric surgical patients under 18 years of age in Latin America, we aim to:
1. determine the perioperative in-hospital mortality rate up to 30 days after surgery;
2. determine the incidence of severe intraoperative adverse events;
3. determine the association between preoperative, intraoperative, and infrastructural
factors and postoperative complications and death.
Methods
Study design
14-day Latin American international multicenter prospective cohort study of pediatric
patients (<18 years) undergoing surgery.
Inclusion criteria
All of the consecutive patients under 18-years-old who were admitted to participating
hospitals during the study period and who underwent elective and nonelective surgeries will
be included in the study. This analysis will include outpatient surgeries and surgical
procedures outside of operating rooms requiring local or general anesthesia. Recruitment will
occur for fourteen days, starting on the date chosen by each participating hospital within
the study cohort period (to be determined).
Exclusion criteria
1. patients undergoing radiological or other procedures that do not require general
anesthesia or in which general anesthesia is performed but no procedure is performed
(e.g., general anesthesia during MRI);
2. patients undergoing obstetric surgery.
Hospitals
Our goal is to recruit as many Latin American hospitals as possible. Each hospital will
receive an individual report that compares its dataset with that of the overall national
cohort.
Ethics in research and informed consent
Research ethics and regulatory approvals will be sought before the initiation of the study in
each location by using national research legislation/guidelines for that country.
National leaders will ensure that the necessary ethical and regulatory approvals are obtained
for participating hospitals in their country. Hospitals can only record data if there is
ethical approval or an equivalent waiver.
This study is a large-scale clinical audit; therefore, it does not pose a significant risk to
the study population. In most, if not all, countries, there will be no requirement for
individual patient consent, as all of the data will be anonymized and are expected to be
recorded as part of routine clinical practice.
A precedent has already been set from an international perspective. In the original EuSOS
study, consent was provided in 27 of the 28 participating European countries. (13) In the
ASOS study (12) and the ASOS-2 trial, consent was provided in most hospitals. In African
pediatric perioperative studies, written informed consent was provided by six of eight ethics
committees in the SAPSOS (5) study. Additionally, in a study in Kenya, written informed
consent was provided in all 24 participating hospitals. (11) The LASOS study also obtained a
consent form waiver from the coordinating center (Hospital das ClĂnicas HCFMUSP).
Informational signage documents will be used at participating sites to ensure that all of the
patients and parents/guardians know that the hospital is participating in the study. These
handover documents will be placed in critical areas of the participating hospitals, with
explanations of the dates and nature of the study.
Recruitment and screening
We expect that all consecutive pediatric patients under 18 years undergoing elective and
nonelective surgeries will be included in the study. Each hospital must record and submit a
triage record of all of the eligible patients. Publicity through the appropriate hospital
notices and signage will inform patients, their parents/guardians, and the public that the
hospital is participating in the study.
Data collection and grouping
Each hospital will individually collect and record data on an electronic or paper case
recording form (CRF) for each recruited patient. Paper CRFs will be stored in a locked office
at each hospital, as they will include patient-identifiable data to allow for the tracking of
clinical outcomes.
Data will be pseudoanonymized by generating a unique numeric code and transcribed by local
investigators into a secure, password-protected electronic CRF on the REDCap platform. Each
patient will be solely identified on the electronic CRF by their numerical code; thus, the
study coordinating team can only trace the data back to an individual patient with contact
with the local team. A participant (patient) list will be used at each hospital to match the
identification codes in the database to individual patients to record clinical results and to
provide any missing data points. Access to the data entry system will be protected by the
username and password provided during the registration process to individual local
investigators. All of the electronic data transfers between participating hospitals and the
coordinating center will be encrypted by using a secure protocol (HTTPS/SSL 3.0 or higher).
When individual hospitals are unable to access the registration form over the internet,
pseudoanonymous coded data can also be faxed, registered mailed, emailed, or WhatsApp
messaged to the coordinating center (if necessary).
Each hospital will maintain a secure trial file, including a protocol, local investigator
delegation record, ethics approval documentation, participant list, and other documentation
(such as trial definitions).
A printout of the final summary of the included patients with essential variables should be
produced for each hospital, along with the submission of final data for double-checking for
completeness and accuracy.
Sample size calculation
We plan to recruit as many hospitals from each participating country as possible and ask them
to include all eligible patients in the study. We do not have a specific sample size, and
statistical models will be adapted to the event rate provided by the recruited sample to
avoid inappropriate use of any logistic regression models.
Statistical analysis
The data to be collected are all collected as part of routine clinical care. Categorical
variables will be described as proportions and compared by using chi-square tests. Continuous
variables will be described as the mean and standard deviation if normally distributed or as
the median and interquartile range if not normally distributed. The univariate analysis will
test factors associated with postoperative complications, intensive care admission, and
in-hospital death.
Hierarchical multilevel logistic regression models will be constructed to identify factors
that are independently associated with these outcomes and to adjust for differences in
confounding factors. Factors will be entered into the models based on their univariate
relationship with the outcome (p<0.05), biological plausibility, and low rate of missing
data. Logistic regression results will be reported as adjusted odds ratios (ORs) with 95%
confidence intervals. Moreover, models will be evaluated by using sensitivity analyses to
explore possible interacting factors and to examine any effect on the results. A statistical
analysis plan will be written before the analysis.
Primary outcome
Postoperative complications in the hospital up to 30 days after surgery.
Secondary outcomes
1. Mortality on the day of surgery;
2. Hospital mortality up to 30 days after surgery;
3. Risk factors associated with in-hospital complications;
4. Severe intraoperative critical adverse events;
5. Level of qualification of anesthesia and surgery providers, as well as the number of
specialists per pediatric population;
6. Admission to intensive care.