Latin American Surgical Outcomes Study

NCT05169164 | Completed

• 1 other identifier: LASOS
• Study Type: observational
• Target: 23,000
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Postoperative complications

  In-hospital postoperative complications of any cause, censored at 30 days following surgery for patients who remain in hospital

  30 days

Secondary Outcomes (3)

• Mortality

  30 days

• Hospital stay

  30 days

• Critical care

  30 days

Study Arms (1)

Single group

All adult patients (aged 18 years or older) undergoing elective or emergency surgery with a planned overnight stay. No interventions, only observational.

Other: No intervention, observational

Interventions

No intervention, observational OTHER

No intervention, observational

Single group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Each national group will select a single seven-day period for patient recruitment between 1st April and 31st October 2022. Patients will be identified by the participating sites by review of elective theatre lists, theatre logbooks, handover sheets, emergency admissions and ward lists. All patients undergoing surgery over this period at a hospital taking part in the study will be eligible for inclusion provided they meet the following criteria.

You may qualify if:

• All adult patients (aged 18 years or older) undergoing elective or emergency surgery with a planned overnight stay.
• Surgery is defined as a procedure where a deliberate access to the body is gained via an incision or percutaneous puncture, and where instrumentation is used in addition to the puncture needle, or instrumentation via a natural orifice.

You may not qualify if:

• Patients who are undergoing planned day-case surgery or radiological procedures.

Sponsors & Collaborators

• University of Sao Paulo: lead
• Queen Mary University of London: collaborator

Study Sites (1)

Banco de Prótesis

Montevideo, Uruguay

Location

Related Publications (2)

• Latin American Surgical Outcomes Study (LASOS) group. Patient outcomes after surgery in 17 Latin American countries (LASOS): a 7 day prospective cohort study. Lancet Glob Health. 2025 Apr;13(4):e635-e645. doi: 10.1016/S2214-109X(24)00558-8.

  PMID: 40155102 DERIVED

• Hajjar LA, Quintao VC, Vieira APZ, Nakada LN, Pearse RM, Ramirez MBD, la Medina AR, Alvarez A, McLoghlin S, Boccalatte L, Padmore G, Feraudy I, Martinez M, Villablanca N, Perez C, Calvache JA, Lincango E, Sosa R, Shu S, Riva J, Godinez L, Frias M, Major D, Licea M, Batista S, Charles S, Vaca M, Rosado ID, Borunda D, Zaky OB, Cardona CMC, Carmona MJC, Stefani LC. Latin American surgical outcomes study: study protocol for a multicentre international observational cohort study of patient outcomes after surgery in Latin American countries. BJA Open. 2022 Aug 19;3:100030. doi: 10.1016/j.bjao.2022.100030. eCollection 2022 Sep.

  PMID: 37588582 DERIVED

Related Links

• Study Principal Web-site

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ludhmila Hajjar, MD, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: December 23, 2021
• Study Start: April 1, 2022
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: August 9, 2023

Record last verified: 2023-08

Locations

UR (1)