Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

African Surgical Outcomes Study (ASOS) (ASOS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03044899
Recruitment Status : Completed
First Posted : February 7, 2017
Last Update Posted : February 7, 2017
Sponsor:
Collaborator:
Medical Research Council, South Africa
Information provided by (Responsible Party):
University of KwaZulu

Brief Summary:

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.


Condition or disease Intervention/treatment
Surgery Surgery- Complications Mortality Procedure: All surgeries in adult patients

Show Show detailed description

Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 11422 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 30 Days
Official Title: African Surgical Outcomes Study (ASOS): An African, Multi-centre Seven Day Evaluation of Patient Care and Clinical Outcomes for Patients Undergoing Surgery
Actual Study Start Date : February 1, 2016
Actual Primary Completion Date : June 30, 2016
Actual Study Completion Date : June 30, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: After Surgery

Group/Cohort Intervention/treatment
Adult surgical patients
All surgeries in adult patients
Procedure: All surgeries in adult patients
All surgeries in adult patients




Primary Outcome Measures :
  1. Incidence of in-hospital postoperative complications in adult surgical patients in Africa [ Time Frame: In-hospital upto 30 days ]
    Postoperative complications


Secondary Outcome Measures :
  1. Rate of mortality on the day of surgery for patients undergoing surgery in Africa [ Time Frame: 1 day ]
    Mortality on the day of surgery

  2. The in-hospital mortality rate for patients undergoing surgery in Africa [ Time Frame: In-hospital upto 30 days ]
    In-hospital mortality



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Seven day, African national multi-centre cohort study of adult (≥18 years) patients undergoing surgery.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03044899


Locations
Layout table for location information
Algeria
National Coordination Office
Algiers, Algeria, 16000
Benin
National Coordination Office
Cotonou, Benin
Burundi
National Coordination Office
Bujumbura, Burundi
Cameroon
National Coordination Office
Mutengene, Cameroon
Congo, The Democratic Republic of the
National Coordination Office
Kinshasa, Congo, The Democratic Republic of the
Congo
National Coordination Office
Brazzaville, Congo
Egypt
National Coordination Office
Cairo, Egypt
Ethiopia
National Coordination Office
Addis Ababa, Ethiopia
Gambia
National Coordination Office
Banjul, Gambia
Ghana
National Coordination Office
Kumasi, Ghana
Kenya
National Coordination Office
Nairobi, Kenya
Libyan Arab Jamahiriya
National Coordination Office
Tripoli, Libyan Arab Jamahiriya
Madagascar
National Coordination Office
Androhibe, Tana, Madagascar
Mali
National Coordination Office
Bamako, Mali
Mauritius
National Coordination Office
Rose Belle, Mauritius
Namibia
National Coordination Office
Windhoek, Namibia
Nigeria
National Coordination Office
Ibadan, Nigeria
Niger
National Coordination Office
Niamey, Naimey, Niger
Senegal
National Coordination Office
Dakar, Senegal
South Africa
University of Kwazulu-Natal
Congella, Kwazulu-Natal, South Africa, 4013
Tanzania
National Coordination Office
Mwanza, Tanzania
Togo
National Coordination Office
Tokoin, Lomé, Togo
Uganda
National Coordination Office
Kampala, Uganda
Zambia
National Coordination Office
Lusaka, Lusaka Province, Zambia
Zimbabwe
National Coordination Office
Harare, Harare Province, Zimbabwe
Sponsors and Collaborators
University of KwaZulu
Medical Research Council, South Africa
Investigators
Layout table for investigator information
Principal Investigator: Bruce Biccard, MD, PhD University of KwaZulu

Additional Information:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
ASOS Protocol version 1.0

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: University of KwaZulu
ClinicalTrials.gov Identifier: NCT03044899    
Other Study ID Numbers: ASOS
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: February 7, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of KwaZulu:
Surgery
Complications
Mortality