MedTrace Logo

Latin American Surgical Outcomes Study

NCT05169164 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 23000

Last updated 2023-08-09

No results posted yet for this study

Summary

Methods: International, seven-day observational cohort study of complications following elective or emergency surgery. Objectives: To provide detailed data describing post-operative complications and associated mortality. Number of participants: Our aim is to recruit as many patients from as many hospitals as possible in Latin American nations. Eligible countries for participation: Countries and dependencies in Latin America that are situated in the area stretching from the northern border of Mexico to the southern tip of South America, including the Caribbean. Inclusion criteria: all adult patients aged 18 years or older undergoing elective or emergency surgery during the seven-day study period with a planned overnight stay. Exclusion criteria: patients who are undergoing planned day-case surgery or radiological procedures. Statistical methodology and analysis: Single and multi-level logistic regression models will be constructed to identify factors independently associated with these outcomes and to adjust for differences in confounding factors. A single final analysis is planned at the end of the study. A pre-defined analysis will focus on outcomes of patients who have undergone caesarean section. Study duration: Each nation will select a 7-day period between 1st April and 31th October 2022.

Conditions

  • Postoperative Complications
  • Mortality

Interventions

OTHER

No intervention, observational

No intervention, observational

Sponsors & Collaborators

  • Queen Mary University of London

    collaborator OTHER

  • University of Sao Paulo

    lead OTHER

Principal Investigators

  • Ludhmila Hajjar, MD, PhD · University of Sao Paulo

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-01
Primary Completion
2023-03-31
Completion
2023-03-31

Countries

  • Uruguay

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05169164 on ClinicalTrials.gov