An African, Multi-centre Evaluation of Patient Care and Clinical Outcomes for Paediatric Patients Undergoing Surgery

NCT05061407 | Completed

• 1 other identifier: ASOS-Paeds
• Study Type: observational
• Target: 8,625
• Locations: 2 countries
• Sites: 2

Brief Summary

Access to safe surgery is a basic human right. This is highlighted by the work of the Lancet Commission on Global Surgery. There is a large burden of surgical disease in the paediatric surgical population with a large unmet need. In Africa, children comprise a significant proportion of the population with approximately 50% of the population being ≤19 years old. Limited data from Africa suggests the risk factors for, incidence and outcomes associated with paediatric surgical complications differ from HICs. The African Surgical Outcomes Study (ASOS) has described surgical outcomes in adult patients in Africa. There is a need to determine the burden of the complications in paediatric surgical patients in Africa, and the risk factors for and the type of complications experienced. Once this study is completed, the investigators will be able to target appropriate interventions to improve surgical outcomes for children in Africa. The investigators have the capacity to do this important work, through the African Perioperative Research Group (APORG) group.

Conditions

Paediatric Surgery; Perioperative/Postoperative Complications; Perioperative Outcomes; Hospital Mortality; Developing Countries; Outcome Assessment; Paediatrics; Prospective Studies; Surgery

Outcome Measures

Primary Outcomes (1)

• Postoperative complications

  Incidence of in-hospital postoperative complications in paediatric surgical patients in Africa.

  Until hospital discharge censored at 30 days postoperative

Secondary Outcomes (6)

• Postoperative mortality

  Until hospital discharge censored at 30 days postoperative

• Access to surgery

  Until hospital discharge censored at 30 days postoperative

• Intraoperative critical incidents

  Until hospital discharge censored at 30 days postoperative

• Anesthesia and surgery providers

  Until hospital discharge censored at 30 days postoperative

• Rate of admission to critical care

  Until hospital discharge censored at 30 days postoperative

Study Arms (1)

Paediatric surgical patients

All patients \< 18 years old, admitted to participating hospitals during the study period who undergo elective and non-elective surgery

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All patients less than 18 years old, admitted to participating hospitals during the study period who undergo elective and non-elective surgery.

You may qualify if:

• Consecutive patients \< 18 years, admitted to participating hospitals during the study period
• elective and non-elective surgery (including day case surgery)
• operative procedures outside operating theatres where a general anaesthetic (GA) is performed.

You may not qualify if:

• radiological or other procedures not requiring general anaesthesia, or where general anaesthesia is performed but no procedure is performed e.g. general anaesthesia during magnetic resonance imaging (MRI).
• Obstetric surgery.
• Prior participation in ASOS-Paeds.

Sponsors & Collaborators

• University of KwaZulu: lead
• University of Cape Town: collaborator
• African Perioperative Research Group (APORG): collaborator
• Safe Surgery South Africa (SSSA): collaborator

Study Sites (2)

Inkosi Albert Luthuli Central Hospital

Durban, KwaZuluNatal, South Africa

Location

Ribat Teaching Hospital

Khartoum, Sudan

Location

Related Publications (1)

• ASOS-Paeds Investigators. Outcomes after surgery for children in Africa (ASOS-Paeds): a 14-day prospective observational cohort study. Lancet. 2024 Apr 13;403(10435):1482-1492. doi: 10.1016/S0140-6736(24)00103-X. Epub 2024 Mar 22.

  PMID: 38527482 DERIVED

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alexandra Torborg

  University of KwaZulu

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 4, 2021
• First Posted: September 29, 2021
• Study Start: January 15, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: March 19, 2025

Record last verified: 2025-03

Locations

SU (1); ZA (1)