Surgery Clinical Trial
— ASOSOfficial title:
African Surgical Outcomes Study (ASOS): An African, Multi-centre Seven Day Evaluation of Patient Care and Clinical Outcomes for Patients Undergoing Surgery
Verified date | February 2017 |
Source | University of KwaZulu |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
STUDY OBJECTIVE To confirm the incidence of in-hospital postoperative complications in adult
surgical patients in Africa.
STUDY DESIGN Seven day, African national multi-centre prospective observational cohort study
of adult (≥18 years) patients undergoing surgery. Patients will be followed up for a maximum
of 30 days. We will follow the original International Surgical Outcomes Study (ISOS) study
design.
The primary outcome is in-hospital postoperative complications in adult surgical patients in
Africa. Secondary outcomes include in-hospital mortality and the relationship between
postoperative complications and postoperative mortality.
The intention is to present a representative sample of surgical outcomes across all African
countries. This study will run between February and March 2016.
Status | Completed |
Enrollment | 11422 |
Est. completion date | June 30, 2016 |
Est. primary completion date | June 30, 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - All consecutive patients admitted to participating centres undergoing elective and non-elective surgery commencing during a seven day study cohort period with a planned overnight hospital stay following surgery. The recruitment week will run between February and May 2016. Exclusion Criteria: - Patients undergoing planned day-case surgery or radiological procedures not requiring anaesthesia. |
Country | Name | City | State |
---|---|---|---|
Algeria | National Coordination Office | Algiers | |
Benin | National Coordination Office | Cotonou | |
Burundi | National Coordination Office | Bujumbura | |
Cameroon | National Coordination Office | Mutengene | |
Congo | National Coordination Office | Brazzaville | |
Congo, The Democratic Republic of the | National Coordination Office | Kinshasa | |
Egypt | National Coordination Office | Cairo | |
Ethiopia | National Coordination Office | Addis Ababa | |
Gambia | National Coordination Office | Banjul | |
Ghana | National Coordination Office | Kumasi | |
Kenya | National Coordination Office | Nairobi | |
Libyan Arab Jamahiriya | National Coordination Office | Tripoli | |
Madagascar | National Coordination Office | Androhibe | Tana |
Mali | National Coordination Office | Bamako | |
Mauritius | National Coordination Office | Rose Belle | |
Namibia | National Coordination Office | Windhoek | |
Niger | National Coordination Office | Niamey | Naimey |
Nigeria | National Coordination Office | Ibadan | |
Senegal | National Coordination Office | Dakar | |
South Africa | University of Kwazulu-Natal | Congella | Kwazulu-Natal |
Tanzania | National Coordination Office | Mwanza | |
Togo | National Coordination Office | Tokoin | Lomé |
Uganda | National Coordination Office | Kampala | |
Zambia | National Coordination Office | Lusaka | Lusaka Province |
Zimbabwe | National Coordination Office | Harare | Harare Province |
Lead Sponsor | Collaborator |
---|---|
University of KwaZulu | Medical Research Council, South Africa |
Algeria, Benin, Burundi, Cameroon, Congo, Congo, The Democratic Republic of the, Egypt, Ethiopia, Gambia, Ghana, Kenya, Libyan Arab Jamahiriya, Madagascar, Mali, Mauritius, Namibia, Niger, Nigeria, Senegal, South Africa, Tanzania, Togo, Uganda, Zambia, Zimbabwe,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of in-hospital postoperative complications in adult surgical patients in Africa | Postoperative complications | In-hospital upto 30 days | |
Secondary | Rate of mortality on the day of surgery for patients undergoing surgery in Africa | Mortality on the day of surgery | 1 day | |
Secondary | The in-hospital mortality rate for patients undergoing surgery in Africa | In-hospital mortality | In-hospital upto 30 days |
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