South African Paediatric Surgical Outcomes Study (SAPSOS)

NCT03367832 | Completed

• 1 other identifier: SAPSOS
• Study Type: observational
• Target: 2,025
• Locations: 1 country
• Sites: 1

Brief Summary

There are few data of paediatric peri-operative morbidity and mortality in South Africa. There is little information on the burden or profile of surgical disease in the paediatric population, the level of anaesthesia or surgical care (specialist versus non-specialist) for paediatric patients, the quality of peri-operative care or contributing factors to poor outcomes. In order to understand current paediatric peri-operative morbidity and mortality in South Africa, it is important to start obtaining these data. Risk factors can be identified and changes can be in implemented accordingly to improve future outcomes. The study will take place over fourteen-days. It is a South African national multi-centre prospective cohort study of paediatric patients (\<16 years) undergoing surgery. The SAPSOS study (as was the South African Surgical Outcomes Study (SASOS) study) will be based on the methodology of the European Surgical Outcomes Study (EuSOS). This study has important public health implications for South Africa as surgery is now recognized internationally as an essential part of public health, yet still needs to be defined as a priority in South Africa. Policy-makers and healthcare providers need evidence to plan resource allocation in a way that will improve quality and outcomes. The data from SAPSOS and SASOS, would provide a platform for government and health care providers in South Africa to appropriately allocate funding, make policy decisions and plan future peri-operative healthcare in South Africa.

Conditions

Anesthesia; Postoperative Complications; Child Mortality; Hospital Mortality; Pediatrics; Surgery

Outcome Measures

Primary Outcomes (1)

• Postoperative complications

  In-hospital postoperative complications in paediatric surgical patients in South Africa

  30 days

Secondary Outcomes (3)

• Mortality

  24 hours

• In-hospital Mortality

  30 days

• Critical Care

  30 days

Study Arms (1)

Paediatric surgical patients

All patients \< 16 years, admitted to participating centres during the study period who undergo elective and non-elective surgery

Eligibility Criteria

• Age: Up to 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Fourteen-day, South African national multi-centre prospective cohort study of paediatric patients (\<16 years) undergoing surgery

You may qualify if:

• All consecutive patients \< 16 years, admitted to participating centres during the study period who undergo elective and non-elective surgery. This will include day case surgery and operative procedures outside operating theatres where a general anaesthetic (GA) is performed. -

You may not qualify if:

• Patients undergoing radiological or other procedures not requiring general anaesthesia, or where general anaesthesia is performed but no procedure is done e.g. GA during a magnetic resonance imaging (MRI).
• Obstetric surgical procedures. -

Sponsors & Collaborators

• University of KwaZulu: lead
• South African Society of Anaesthesiologists (SASA): collaborator
• Safe Surgery South Africa (SSA): collaborator

Study Sites (1)

University of KwaZuluNatal

Durban, KwaZuluNatal, South Africa

Location

Related Publications (3)

• LeBrun DG, Chackungal S, Chao TE, Knowlton LM, Linden AF, Notrica MR, Solis CV, McQueen KA. Prioritizing essential surgery and safe anesthesia for the Post-2015 Development Agenda: operative capacities of 78 district hospitals in 7 low- and middle-income countries. Surgery. 2014 Mar;155(3):365-73. doi: 10.1016/j.surg.2013.10.008. Epub 2013 Oct 11.

  PMID: 24439745 BACKGROUND

• 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 BACKGROUND

• 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 DERIVED

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alexandra Torborg, MBChB

  University of KwaZulu

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2017
• First Posted: December 11, 2017
• Study Start: May 22, 2017
• Primary Completion: September 20, 2017
• Study Completion: September 20, 2017
• Last Updated: December 12, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Once the primary publications have been completed
• Access Criteria: Full study protocol and ethics approval must be submitted to the Steering Committee who will then make a decision.

Locations

ZA (1)