Background 

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. If we do this, we will be able to target appropriate interventions to improve surgical outcomes for children in Africa. We have the capacity to do this important work, through the African Perioperative Research Group (APORG) group.

Study Introduction

Introduction Slides

Study Objective

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

Study Design

Fourteen-day, international African multi-centre prospective cohort study of paediatric patients (under <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 and territories. This study will run from September 2021 until September 2022.

Prepatory 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.

Study Dates

National lead will determine (with their team) the start date for their country

Declare your interest

Please click on the link below to declare your interest for the ASOS-Paeds study.

Declare your interest

FAQs

Administrative Questions

What is the screening log?

All studies need to report the number of eligible patients during the recruitment period. This is the screening log. It is important that the ASOS-Paeds Hospital Lead Investigator reports the number of eligible ASOS-Paeds patients from the previous 24 hours in the screening log every morning.

Where can I find all the up to date study documents?

All study documents are available on the ASOS-Paeds Website (http://asos.org.za/index.php/asos-paeds) and on the APON platform (https://periopnetwork.org). Please ensure that you are using version 2 of the case record form (CRF). If you are not sure, please check that it is the same as the CRF on the website.

What is APON and why do I need to register on this platform?

APON is a digital platform designed for researchers in Africa to connect, share and collaborate on various research projects across the continent. Only investigators who have registered can be included in the publication(s) for ASOS-Paeds and so it is important that all hospital investigators who take part register on APON. To register, go to: https://periopnetwork.org

Which CRFs need to be completed for the study?

When recruiting, a CRF for every patient and a daily CRF for the number of eligible patients (the screening log) needs to be completed. Before recruitment starts, a hospital information document also needs to be completed along with the site-readiness questionnaire.

Enrolment/Recruitment Questions

How do we indicate patients being transferred?

If a patient is transferred from your facility, the patient is treated as discharged and the post-op CRF completed. The new hospital should also be contacted and the patient should not be included again if he/she already had surgery.

If a patient is transferred to your facility and already had surgery, please do not recruit the patient again.
If the patient did not have surgery at the previous hospital, please recruit the patient.

What are the inclusion criteria for the study?

We are including any patient undergoing a surgical procedure. This procedure can be either in or outside of operating room, provided they receive anaesthesia.

Inclusion and exclusion criteria as per the study protocol

Inclusion criteria

All consecutive patients < 18 years, admitted to participating hospitals during the study period who undergo elective and non-elective surgery. This will include day case surgery and operative procedures outside of operating theatres requiring local or general anaesthesia. Recruitment will run for fourteen days, commencing on the date chosen by each participating hospital within the study cohort period.

Exclusion criteria

  • 1. Patients undergoing 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. Patients having obstetric surgery.
  • 3. Prior participation in the ASOS-Paeds.

    • Which patients are eligible for the study?

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

    Should day cases be included in the study?

    Yes. Day cases are included in the study, there does not need to be an overnight admission. In this case the days in hospital will be indicated as zero.

    Is it only paediatric surgery procedures that will be included in the study?

    No, not just paediatric surgery procedures should be included, but all procedures in patients less than 18 years. This includes ENT, neurosurgery, urology, plastic surgery, etc.

    Which patients should not be included in the study?

  • 1. Any patient having a Caesarean section

  • 2. Any patient having a general anaesthetic outside the operating room that is not for and intervention or procedure eg a diagnostic MRI scan

  • 3. Patients 18 years and older

  • 4. Patients previously recruited in ASOS-Paeds

    • Patient CRF Questions

    What if a patient had previous operations OUTSIDE the recruitment period

    If a patient had a previous operation before recruitment started, they are recruited to the study and the operation counts as the first surgery, but if they came back for a subsequent surgery in the recruitment period then it is not included.

    What if there are previous complications existing before surgery

    If patients came in with a complication, it is not recorded. Only new complications are reported. For example, if a patient comes in with an infection it doesn't count, but if they get a new infection then it is counted as a complication of this surgery.

    If a patient had to go for a second surgery INSIDE the recruitment period

    You should not complete a new CRF form if a patient comes back for surgery if they have already been included in the study. If they had to have a second operation, the option "re-operation" is selected on the postoperative follow up CRF. Any postoperative complication needs to be recorded as appropriate.

    Under what 'type of surgery' is an umbilical or inguinal hernia repair

    Please list umbilical and inguinal hernia operations under 'other' category for 'type of surgery'

    What is the meaning of "After Hours" on the patient CRF form?

    After hours refers to what is considered after hours at your hospital. Everyone has different work patterns so after hours could be different in different places.

    I can not see a particular medical co-morbidity (ex. SCD) as part of the comorbidities and no column for 'others'. In that regard, what do we do?

    We realise that some patients may have important data which we have not asked for. The CRF has been designed to request only the most important patient data.

    What to select under co-morbid disease

    We have not made definitions for all these diseases. We simply want doctors to give what they believe are the most appropriate answers. If the patient probably has the disease, then tick the box. If they probably do not have the disease, then leave it blank.

    Hospital information sheet

    What needs to be included on the hospital information sheet when recording the number of beds, operating rooms, and operations performed.

    It is importnat to give both the total number of all hospital beds and operating rooms, as well as the total number of all operations and then also the number of operations in patients less than 18 years.

    How many operating lists per week:

    Full day slates on average

    How many surgical cases are in total are done on average per month in your hospital?

    Any surgical procedure requiring any form of anaesthesia.

    Click below to download the study documents

    ASOS-Paeds Study Summary

    English
    French
    Arabic

    Study Protocol

    English
    French
    Arabic

    ASOS-Paeds Broadcasting Document

    English
    French
    Arabic

    ASOS-Paeds Broadcasting Infographic

    English
    French
    Xhosa
    Afrikaans
    Sesotho
    Zulu
    Venda
    XiTsonga

    ASOS-Paeds Editable Broadcasting Infographic

    Hospital Information

    English
    French
    Arabic

    ASOS-Paeds CRF document

    English
    French
    Arabic

    ASOS-Paeds Screening Log

    English
    Arabic

    ASOS-Paeds Outcomes Definitions

    English
    French
    Arabic

    Ethical Approval

    ASOS-Paeds Ethical Approval

    Participating Countries and Territories

    Countries and territories confirmed to be participating in ASOS-Paeds:

    • Algeria

      • National Leader: Prof Souad Bouaoud
      National Leader: Dr Meriem Abdoun

    • Burkina Faso

      • National Leader: Dr Kélan Bertille

    • Cameroon

      • National Leader: Dr Raymond Ndikontar

    • Congo

      • National Leader: Prof Fabrice Otiobanda

    • Democratic Republic of the Congo

      • National Leader: Dr Dolly Munlemvo
      National Leader: Dr Jean Kalongo

    • Egypt

      • National Leader: Prof Maher Fawzy
      National Leader: Dr Mahmoud Elfiky

    • Ethiopia

      • National Leader: Dr Desalegn Bekele
      National Leader: Dr Fitsum Kefle

    • Gambia

      • National Leader: Dr Mustapha Bittaye
      National Leader: Dr Ahmadou Lamin Samateh

    • Ghana

      • National Leader: Dr Mama Yaa Nyarko

    • Guinea

      • National Leader: Dr Joseph Donamou

    • Kenya

      • National Leader: Dr Thomas Muinga Chokwe

    • Libya

      • National Leader: Dr Muhammed Elhadi
      National Leader: Dr Yousef Kryem

    • Madagascar

      • National Leader: Prof Lalatiana Andriamanarivo
      National Leader: Prof Arsitide Romain Raherison

    • Malawi

      • National Leader: Dr Wakisa Mulwafu
      National Leader: Dr Emma Thomson

    • Mali

      • National Leader: Prof Yakaria Coulibaly

    • Mauritius

      • National Leader: Dr Kushal Ramkhalawan

    • Morocco

      • National Leader: Dr Ahmed Rhassane

    • Namibia

      • National Leader: Dr Sarah Shalongo

    • Niger

      • National Leader: Dr Maman Sani Chaibou

    • Nigeria

      • National Leader: Dr Adesoji O Ademuyiwa
      National Leader: Dr Babatunde Babasola Osinaike

    • Rwanda

      • National Leader: Dr Yayehyirad Mekonnen Ejigu

    • Seychelles

      • National Leader: Dr Marvin Fanny

    • Senegal

      • National Leader: Dr Mamadou Mour Traore

    • Sierra Leone

      • National Leader: Dr Isaac Olufemi Smalle

    • Somalia

      • National Leader: Dr Mohamed Omar

    • Somaliland

      • National Leader: Dr Mubarak Mohamed
      National Leader: Dr Shukri Dahir

    • South Africa

      • National Leader: Dr Heidi Meyer

    • Sudan

      • National Leader: Dr Tarig Fadalla
      National Leader: Dr Bareeq Abdallah

    • Tunisia

      • National Leader: Nahla Kechiche

    • Uganda

      • National Leader: Dr Mary Nabukenya
      National Leader: Dr Adam Hewitt-Smith

    • Zimbabwe

      • National Leader: Dr Pisirai Ndarukwa

      If you want to participate in the ASOS-Paeds Study feel free to contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.