Surgery Clinical Trial
— ASOS-2Official title:
African Surgical OutcomeS-2 (ASOS-2) Trial
NCT number | NCT03853824 |
Other study ID # | ASOS-2 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 6, 2019 |
Est. completion date | August 31, 2020 |
Verified date | September 2020 |
Source | University of Cape Town |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
An international, multicentre, African cluster randomised trial.
Primary objective :
To determine whether increased postoperative surveillance in high-risk adult surgical
patients reduces overall in-hospital mortality in surgical patients aged 18 years and over in
Africa.
Primary outcome measure:
In-hospital mortality, censored at 30 days if the patient is still alive and in-hospital.
Secondary objective:
To determine whether increased postoperative surveillance in high-risk adult surgical
patients reduces the overall incidence of the composite of severe in-hospital complications
and mortality in adult surgical patients aged 18 years and over in Africa.
Secondary outcome measure:
Composite of severe in-hospital complications and mortality, censored at 30 days if the
patient is still alive and in-hospital.
Status | Completed |
Enrollment | 27507 |
Est. completion date | August 31, 2020 |
Est. primary completion date | August 31, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - All consecutive adult patients aged 18 years and over admitted to participating centres undergoing elective and non-elective surgery Exclusion Criteria: - Prior participation in ASOS-2 |
Country | Name | City | State |
---|---|---|---|
South Africa | Groote Schuur Hospital | Cape Town | Western Cape |
Lead Sponsor | Collaborator |
---|---|
University of Cape Town | Bill and Melinda Gates Foundation |
South Africa,
Biccard BM, Madiba TE, Kluyts HL, Munlemvo DM, Madzimbamuto FD, Basenero A, Gordon CS, Youssouf C, Rakotoarison SR, Gobin V, Samateh AL, Sani CM, Omigbodun AO, Amanor-Boadu SD, Tumukunde JT, Esterhuizen TM, Manach YL, Forget P, Elkhogia AM, Mehyaoui RM, Zoumeno E, Ndayisaba G, Ndasi H, Ndonga AKN, Ngumi ZWW, Patel UP, Ashebir DZ, Antwi-Kusi AAK, Mbwele B, Sama HD, Elfiky M, Fawzy MA, Pearse RM; African Surgical Outcomes Study (ASOS) investigators. Perioperative patient outcomes in the African Surgical Outcomes Study: a 7-day prospective observational cohort study. Lancet. 2018 Apr 21;391(10130):1589-1598. doi: 10.1016/S0140-6736(18)30001-1. Epub 2018 Jan 3. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | In-hospital severe superficial or deep surgical site, or body cavity infection | Number of Participants with in-hospital severe superficial or deep surgical site, or body cavity infection | In-hospital, and censored at 30 days after surgery if still in-hospital. | |
Other | In-hospital severe urinary tract or acute kidney injury | Number of Participants with in-hospital severe urinary tract or acute kidney injury | In-hospital, and censored at 30 days after surgery if still in-hospital. | |
Other | In-hospital severe bloodstream infection or acute respiratory distress syndrome | Number of Participants with in-hospital severe bloodstream infection or acute respiratory distress syndrome | In-hospital, and censored at 30 days after surgery if still in-hospital. | |
Other | In-hospital severe pneumonia | Number of Participants with in-hospital severe pneumonia | In-hospital, and censored at 30 days after surgery if still in-hospital. | |
Other | In-hospital severe postoperative bleed | Number of Participants with in-hospital severe postoperative bleed | In-hospital, and censored at 30 days after surgery if still in-hospital. | |
Other | In-hospital cardiac arrest | Number of Participants with in-hospital cardiac arrest | In-hospital, and censored at 30 days after surgery if still in-hospital. | |
Other | Other severe complications in-hospital | Number of Participants with other severe complications in-hospital | In-hospital, and censored at 30 days after surgery if still in-hospital. | |
Primary | In hospital mortality. | Number of Participants with In hospital mortality | In-hospital, and censored at 30 days after surgery if still in-hospital. | |
Secondary | Composite of severe in-hospital complications and mortality | Number of Participants with severe in-hospital complications (as defined in the pre-specified complications) and mortality | In-hospital, and censored at 30 days after surgery if still in-hospital. |
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