Clinical Trials Logo

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 10000
Est. completion date February 1, 2025
Est. primary completion date December 30, 2024
Accepts healthy volunteers
Gender All
Age group 1 Day to 18 Years
Eligibility 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. 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.

Study Design


Intervention

Procedure:
Surgery
All children submitted to surgery will be followed until hospital discharge or 30 days postoperatively.

Locations

Country Name City State
Brazil Academic Reserach Organization, Instituto do Coracao, Hospital das Clinicas, Faculdade de Medicina, Universidade de Sao Paulo São Paulo SP

Sponsors (1)

Lead Sponsor Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (6)

Bainbridge D, Martin J, Arango M, Cheng D; Evidence-based Peri-operative Clinical Outcomes Research (EPiCOR) Group. Perioperative and anaesthetic-related mortality in developed and developing countries: a systematic review and meta-analysis. Lancet. 2012 — View Citation

Bickler SW, Rode H. Surgical services for children in developing countries. Bull World Health Organ. 2002;80(10):829-35. Epub 2002 Nov 28. — View Citation

Butler EK, Tran TM, Nagarajan N, Canner J, Fuller AT, Kushner A, Haglund MM, Smith ER; SOSAS 4 Country Research Group. Epidemiology of pediatric surgical needs in low-income countries. PLoS One. 2017 Mar 3;12(3):e0170968. doi: 10.1371/journal.pone.0170968 — View Citation

GlobalSurg Collaborative. Determinants of morbidity and mortality following emergency abdominal surgery in children in low-income and middle-income countries. BMJ Glob Health. 2016 Dec 12;1(4):e000091. doi: 10.1136/bmjgh-2016-000091. eCollection 2016. Err — View Citation

Habre W, Disma N, Virag K, Becke K, Hansen TG, Johr M, Leva B, Morton NS, Vermeulen PM, Zielinska M, Boda K, Veyckemans F; APRICOT Group of the European Society of Anaesthesiology Clinical Trial Network. Incidence of severe critical events in paediatric a — View Citation

Torborg A, Cronje L, Thomas J, Meyer H, Bhettay A, Diedericks J, Cilliers C, Kluyts H, Mrara B, Kalipa M, Rodseth R, Biccard B; South African Paediatric Surgical Outcomes Study Investigators. South African Paediatric Surgical Outcomes Study: a 14-day pros — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative in-hospital complication Percentage of postoperative complications in-hospital until 30 days
Secondary Surgical mortality Percentage of surgical mortality in-hospital until 30 days
Secondary Admission to critical care Percentage of children admitted in critical care until 30 days
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04279054 - Decreased Neuraxial Morphine After Cesarean Delivery Early Phase 1
Active, not recruiting NCT04580030 - Tricuapid Annular Plane Sistolic Excursion Before General Anesthesia Can Predict Hypotension After Induction
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Recruiting NCT04099693 - A Prospective Randomized Study of General Anesthesia Versus Anesthetist Administered Sedation for ERCP
Terminated NCT02481999 - Pre- and Postoperative EEG-Monitoring for Children Aged From 0,5 to 8 Years
Completed NCT04235894 - An Observer Rating Scale of Facial Expression Can Predict Dreaming in Propofol Anesthesia
Recruiting NCT05525104 - The Effect of DSA on Recovery of Anaesthesia in Children (Het Effect Van DSA op Het Herstel na Anesthesie Bij Kinderen). N/A
Recruiting NCT05024084 - Desflurane and Sevoflurane Minimal Flow Anesthesia on Recovery and Anesthetic Depth Phase 4
Completed NCT04204785 - Noise in the OR at Induction: Patient and Anesthesiologists Perceptions N/A
Completed NCT03277872 - NoL, HR and MABP Responses to Tracheal Intubation Performed With MAC Blade Versus Glidescope N/A
Terminated NCT03940651 - Cardiac and Renal Biomarkers in Arthroplasty Surgery Phase 4
Terminated NCT02529696 - Measuring Sedation in the Intensive Care Unit Using Wireless Accelerometers
Completed NCT05346588 - THRIVE Feasibility Trial Phase 3
Terminated NCT03704285 - Development of pk/pd Model of Propofol in Patients With Severe Burns
Recruiting NCT05259787 - EP Intravenous Anesthesia in Hysteroscopy Phase 4
Completed NCT02894996 - Does the Response to a Mini-fluid Challenge of 3ml/kg in 2 Minutes Predict Fluid Responsiveness for Pediatric Patient? N/A
Completed NCT05386082 - Anesthesia Core Quality Metrics Consensus Delphi Study
Terminated NCT03567928 - Laryngeal Mask in Upper Gastrointestinal Procedures N/A
Recruiting NCT06074471 - Motor Sparing Supraclavicular Block N/A
Completed NCT04163848 - CARbon Impact of aNesthesic Gas