Clinical trial NCT05061407: An African, Multi-centre Evaluation of Patient Care and Clinical Outcomes for Paediatric Patients Undergoing Surgery
Official title: An African, International Multi-centre Fourteen-day Evaluation of Patient Care and Clinical Outcomes for Paediatric Patients Undergoing Surgery (ASOS-Paeds)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Paediatric Surgery
Perioperative/Postoperative Complications
Perioperative Outcomes
Hospital Mortality
Developing Countries
Outcome Assessment
Paediatrics
Prospective Studies
Surgery
Lead sponsor: University of KwaZulu
Sponsor class: OTHER
Collaborators: name: University of Cape Town
name: African Perioperative Research Group (APORG)
name: Safe Surgery South Africa (SSSA)
First posted: 2021-09-29
Enrollment: 8625
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: Surgery is a cost-effective public health intervention. There are significant disparities in access to and the safety of surgical and anaesthesia services in low and middle-income countries (LMICs) compared to high-income countries (HICs). 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.

Postoperative complications are an important determinant of surgical morbidity and mortality. Limited data from Africa suggests the risk factors for, incidence and outcomes associated with paediatric surgical complications differ from HICs. In the prospective, observational South African Paediatric Surgical Outcomes Study (SAPSOS), the patients in this middle-income country (MIC), had double the incidence of complications, and the types of complications differed from HICs, with a predominance of infective complications. Furthermore, the risk factors for complications (ASA physical status, urgency of surgery, severity of surgery and infective indication for surgery) were different from HICs, where risk factors include gestational age, ASA physical status \>3, a history of cardiovascular disease, and cardiovascular, neurological, or orthopaedic surgical procedures. Postoperative mortality was ten times higher in South Africa than in a prospective study in HICs. A prospective study of paediatric perioperative mortality in 24 Kenyan hospitals showed a 7 day postoperative mortality of 1.7%, which is 17 times higher than that reported in HICs.

The African Surgical Outcomes Study (ASOS) has described surgical outcomes in adult patients in Africa. Patients had a lower risk profile and fewer complications compared to those in HICs. However, the postoperative mortality was twice that of the global average.

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.

STUDY OBJECTIVE To determine the incidence of in-hospital postoperative complications up to 30 days post-surgery in paediatric surgical patients \<18 years in Africa

STUDY DESIGN Fourteen-day, international African multi-centre prospective cohort study of paediatric patients (\<18 years) undergoing surgery. This study will be registered on ClinicalTrials.gov. Patients will be followed up for a maximum of 30 days.

The primary outcome is the incidence of in-hospital postoperative complications in paediatric surgical patients in Africa. Secondary outcome measures include mortality rate for patients \< 18 years undergoing surgery in Africa, risk factors associated with in-hospital complications, time from first presentation to operation, incidence of severe intraoperative critical incidents, level of qualification of anesthesia and surgery providers and number of specialists per paediatric population, and rate of admission to critical care.

The intention is to present a representative sample of paediatric surgical outcomes across all African countries. This study will run from October 2021 until December 2022.

ETHICS APPROVAL A waiver of consent has been approved by the IRB with the proviso that an approved broadcasting document and pictorial description are both placed for patients to see around the hospital and in the relevant wards. The requirement for patient consent is expected to vary according to regulations of the participating nations. the national leaders will ensure ethics approval is obtained form their respective countries and centres. Centres will not be permitted to record data unless ethics approval and an equivalent waiver is in place.

PREPARATORY WORK Prior leadership in the South African Paediatric Surgical Outcomes Study (SAPSOS) and the African Surgical Outcomes Study (ASOS) have ensured tested resource resources necessary to run this study. This will be the first continental collaborative study of paediatric surgical outcomes in Africa.

IMPORTANCE OF THIS STUDY Surgery is associated with significant morbidity. Accurate information regarding the burden of morbidity and mortality associated with paediatric surgery in Africa would allow for appropriate allocation of resources in the future, and the implementation of interventions to improve paediatric patient outcomes. This study therefore has important public health implications for Africa. This study will also provide the necessary data to develop future collaborative work to improve African surgical paediatric patient outcomes.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

1. 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).
2. Obstetric surgery.
3. Prior participation in ASOS-Paeds.

Primary outcomes:
measure: Postoperative complications
timeFrame: Until hospital discharge censored at 30 days postoperative
Secondary outcomes:
measure: Postoperative mortality
timeFrame: Until hospital discharge censored at 30 days postoperative
measure: Access to surgery
timeFrame: Until hospital discharge censored at 30 days postoperative
measure: Intraoperative critical incidents
timeFrame: Until hospital discharge censored at 30 days postoperative
measure: Anesthesia and surgery providers
timeFrame: Until hospital discharge censored at 30 days postoperative
measure: Rate of admission to critical care
timeFrame: Until hospital discharge censored at 30 days postoperative
measure: Number of specialists per paediatric population
timeFrame: Within 6 months of the start of recruitment
Other outcomes:
Locations:
city: Durban
country: South Africa
facility: Inkosi Albert Luthuli Central Hospital
state: KwaZuluNatal
city: Khartoum
country: Sudan
facility: Ribat Teaching Hospital
Study officials:
affiliation: University of KwaZulu
name: Alexandra Torborg
role: PRINCIPAL_INVESTIGATOR
References: