Latin American Surgical Outcomes Study in Pediatric Patients

NCT05934682 | Recruiting

• 1 other identifier: LASOS-Peds
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Complications; Children; Neonate; Infant; Anesthesia

Outcome Measures

Primary Outcomes (1)

• Postoperative in-hospital complication

  Percentage of postoperative complications in-hospital

  until 30 days

Secondary Outcomes (2)

• Surgical mortality

  until 30 days

• Admission to critical care

  until 30 days

Study Arms (1)

Children submitted to surgery

We will follow children submitted to surgery until hospital discharge or until 30 days after surgery.

Procedure: Surgery

Interventions

Surgery PROCEDURE

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

Children submitted to surgery

Eligibility Criteria

• Age: 1 Day - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children submitted to surgery (elective and non-elective).

You may qualify if:

• 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.

You may not qualify if:

• 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);
• patients undergoing obstetric surgery.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Academic Reserach Organization, Instituto do Coracao, Hospital das Clinicas, Faculdade de Medicina, Universidade de Sao Paulo

São Paulo, São Paulo, 05403-000, Brazil

RECRUITING

Related Publications (7)

• 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 Sep 22;380(9847):1075-81. doi: 10.1016/S0140-6736(12)60990-8.

  PMID: 22998717 RESULT

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

  PMID: 12471405 RESULT

• 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. eCollection 2017.

  PMID: 28257418 RESULT

• 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 prospective, observational cohort study of paediatric surgical patients. Br J Anaesth. 2019 Feb;122(2):224-232. doi: 10.1016/j.bja.2018.11.015. Epub 2018 Dec 19.

  PMID: 30686308 RESULT

• 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.

  PMID: 28588977 RESULT

• 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 anaesthesia (APRICOT): a prospective multicentre observational study in 261 hospitals in Europe. Lancet Respir Med. 2017 May;5(5):412-425. doi: 10.1016/S2213-2600(17)30116-9. Epub 2017 Mar 28.

  PMID: 28363725 RESULT

• Quintao VC, de Sousa GS, Torborg A, Vieira A, Consonni F, Rodrigues S, Proenca J, Carlos RV, Clemente M, Alonso N, Neville M, Leite F, Tonello C, Evans F, Garcia-Marcinkiewicz A, Guris R, Herrera J, Andersen A, Schaigorodsky L, Biondini N, Cajas N, Cruzat F, Cortinez LI, Giraldo M, Valle A, Pozo C, Betancourt A, Echeto MA, Dominguez A, Sarmiento L, Gonzalez K, Abrego G, Leguizamon L, Paula L, Lauber C, Lopez G, Biccard BM, Carmona MJ, Hajjar LA. Latin American Surgical Outcomes Study in Paediatrics (LASOS-Peds): study protocol and statistical analysis plan for a multicentre international observational cohort study. BMJ Open. 2024 Sep 23;14(9):e086350. doi: 10.1136/bmjopen-2024-086350.

  PMID: 39313281 DERIVED

MeSH Terms

Conditions

Postoperative Complications

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Vinicius Quintao, MD, PhD

  Postdoctoral fellow

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vinicius Quintao, MD, PhD

CONTACT

+ 55 11 2661-5795; vinicius.quintao@hc.fm.usp.br

Alexandra Vieira, Pharm, MSc

CONTACT

+ 55 11 2661-5795; aro@incor.usp.br

Study Design

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

Study Record Dates

• First Submitted: June 19, 2023
• First Posted: July 7, 2023
• Study Start: December 20, 2023
• Primary Completion: February 28, 2025
• Study Completion: March 30, 2025
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)