Status:
COMPLETED
South African Paediatric Surgical Outcomes Study (SAPSOS)
Lead Sponsor:
University of KwaZulu
Collaborating Sponsors:
South African Society of Anaesthesiologists (SASA)
Safe Surgery South Africa (SSA)
Conditions:
Anesthesia
Postoperative Complications
Eligibility:
All Genders
Up to 15 years
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 leve...
Detailed Description
Methods Fourteen-day, South African national multi-centre prospective cohort study of paediatric patients (\<16 years) undergoing surgery. Centres The investigators aim to recruit from as many Sout...
Eligibility Criteria
Inclusion
- 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. -
Exclusion
- 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. -
Key Trial Info
Start Date :
May 22 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 20 2017
Estimated Enrollment :
2025 Patients enrolled
Trial Details
Trial ID
NCT03367832
Start Date
May 22 2017
End Date
September 20 2017
Last Update
December 12 2017
Active Locations (1)
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1
University of KwaZuluNatal
Durban, KwaZuluNatal, South Africa