Trial Outcomes & Findings for South African Surgical Outcomes Study (NCT NCT02141867)

Results Overview

In hospital mortality

Recruitment status

COMPLETED

Target enrollment

3927 participants

Primary outcome timeframe

Upto 30 days

Results posted on

2016-02-09

Participant Flow

Participant milestones

Participant milestones
Measure	Noncardiac Surgical Patients Noncardiac surgery patients 16 years or older undergoing inpatient surgery
Overall Study STARTED	4021
Overall Study COMPLETED	3927
Overall Study NOT COMPLETED	94

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

South African Surgical Outcomes Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Noncardiac Surgical Patients n=3927 Participants Noncardiac surgery patients 16 years or older undergoing inpatient surgery. Age 43.5 (SD 17.6) years, Male 1994 (50.8%)
Age, Continuous	43.5 years STANDARD_DEVIATION 17.6 • n=5 Participants
Sex: Female, Male Female	1933 Participants n=5 Participants
Sex: Female, Male Male	1994 Participants n=5 Participants
Elective surgery Elective surgery	1795 participants n=5 Participants
Elective surgery Urgent/ Emergent surgery	2120 participants n=5 Participants

PRIMARY outcome

Timeframe: Upto 30 days

In hospital mortality

Outcome measures

Outcome measures
Measure	Noncardiac Surgical Patients n=3927 Participants Noncardiac surgery patients 16 years or older undergoing inpatient surgery
Mortality	123 participants

SECONDARY outcome

Timeframe: Upto 30 days

Outcome measures

Outcome measures
Measure	Noncardiac Surgical Patients n=3927 Participants Noncardiac surgery patients 16 years or older undergoing inpatient surgery
Duration of Hospital Stay	3 Days Interval 1.0 to 6.0

SECONDARY outcome

Timeframe: Upto 30 days

Outcome measures

Outcome measures
Measure	Noncardiac Surgical Patients n=3927 Participants Noncardiac surgery patients 16 years or older undergoing inpatient surgery
Admission to Critical Care After Surgery	255 participants

SECONDARY outcome

Timeframe: Upto 30 days

Outcome measures

Outcome measures
Measure	Noncardiac Surgical Patients n=255 Participants Noncardiac surgery patients 16 years or older undergoing inpatient surgery
Duration of Critical Care Stay	3 Days Interval 1.0 to 7.0

Adverse Events

Non Cardiac Surgery

Serious events: 123 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Non Cardiac Surgery n=3927 participants at risk Non cardiac surgery patients 16 years or older
Surgical and medical procedures In hospital mortality	3.1% 123/3927 • In hospital Observational study

Other adverse events

Adverse event data not reported

Additional Information

Prof Bruce Biccard

South African Surgical Outcomes Study

Phone: +27312604328

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place