International, seven-day observational cohort study of complications following elective or emergency surgery in Latin America
More than 310 million patients undergo surgery worldwide each year with reported hospital mortality between 1 and 4%. Recent estimates suggest that 4.2 million deaths occur within 30 days of surgery, and half of these occur in low and middle-income countries (LMIC). Complications are more common and are a leading cause of long term morbidity and mortality. With the high volumes of surgery performed, there is increasing recognition of the massive potential impact of even small improvements in perioperative care.
The International Surgical Outcomes Study (ISOS) confirmed the association between complications and death after surgery at a global scale, but predominantly included high-income nations. More recently, the African Surgical Outcomes Study (ASOS) found that patients undergoing surgery in African nations were twice as likely to die than those in high-income countries (HIC), despite being younger with fewer co-morbid diseases.
Latin America describes a geographic area including 25 nations, and countries within the region have some of the highest income disparity worldwide. Rapid demographic and societal changes have led to an increasing burden of non-communicable disease. Provision of healthcare varies widely within Latin America, with a mix of private, social and government funded schemes. A recent report highlighted marked variation within and between countries of surgical provision in Latin America. Given the disparity in socioeconomic status and care models this is perhaps unsurprising. However, it is unclear how these disparities relate to outcomes for individual patients. Our aim is to conduct a seven-day cohort study of adults undergoing in-patient surgery in Latin America to provide detailed data describing post-operative complications and associated mortality.
Frequently Asked Questions
LASOS will run along very similar lines to the previous EuSOS study. ISOS and ASOS studies. Each hospital will collect data on every eligible patient who has surgery during the study week and follow them until they leave hospital to collect further data on complications after surgery. Data will be collected on paper and then entered onto a secure website. Analysis will then start once data collection is complete.
The most obvious difference is that all countries will be eligible to take part in Latin America. In this study we will collect data on elective and urgent surgeries. We also will collect data from cesarean section in a separate CRF.
We have developed a data entry website especially for the project to make this process quicker, simpler and more accurate. A key difference is that patient, hospital and national level data will be anonymised with comparisons made across international regions. Once your data is uploaded and confirmed as complete and accurate, you will be automatically provided with a spreadsheet of the data for your hospital.
We would welcome as many hospitals as possible from Latin America. We want to have hospitals from small and major countries, from healthy and also poor regions.
Each national group will choose a week between 1st April and 31th October 2022. The seven-day recruitment period will begin at 08:00 local time on the Monday of this week and ends at 07:59 on the following Monday.
Every adult patient aged 18 years or older who undergoes elective or urgent surgery which starts (ie induction of anaesthesia) during the seven day cohort week and is planned to stay overnight in hospital. This will include minor, intermediate and major surgery but we will not collect data on day-case (ambulatory) surgery even if they have an unplanned overnight stay in hospital. We will not collect data on patients who have radiological procedures. Patients should be followed up until hospital discharge or for a maximum of 30 days whichever is shorter.
Yes. Patients who have either cardiac or thoracic surgery are eligible.
Yes, we want you to collect data describing young fit patients as well as older ones. We need to find out more about the whole surgical population to understand what happens to the patients at high risk of complications. This means we need to aim to collect data on every patient who fits the criteria.
We realize taking part in LASOS involves a lot of work and we are very grateful to all the investigators for your support. We have carefully balanced collection of important data against the work this involves. The data sheets (CRFs) are very short compared to other studies of this type. The study cohort week lasts only seven days.
Yes. We know very little about the epidemiology of surgery in Latin America and we need to make sure the findings of LASOS are relevant to as many different hospitals as possible so we can understand what types of care are most effective.
Yes. All local investigators who take part in the study are members of the LASOS study group and will be publicly listed on the website. All LASOS publications will be published on behalf of the LASOS study group which means all study group members can list these in their curriculum vitae or resume. All 2000 investigators on the previous EuSOS, ISOS and ASOS studies were listed on Pubmed.
No. The seven-day recruitment period will begin at 08:00 local time on the Monday of this week and ends at 07:59 on the following Monday.
Patients should only be included in the study once. Repeat surgery should only be included if the first procedure took place before the LASOS study week began.
All identifiable data collected, processed and store for the purpose of the project will remain confidential at all times and comply with Good Clinical Practice for research (GCP) guidelines and the principles of the Data Protection Act 1998 (UK). Data will be anonymised prior to transfer to the ISOS study management group except where the patient has given written informed consent to allow transfer of identifiable data. Access to the data entry system will be protected by username and password delivered during the registration process for individual local investigators. All electronic data transfer between participating centres and the co-ordinating centres will be encrypted using SSL/TLS protocol (HTTPS).
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