NCT03853824: ASOS-2

African Surgical OutcomeS-2 (ASOS-2) Trial

Completed NA Last updated 10 September 2020

What this trial tests

NA trial testing Increased postoperative surveillance in Surgery in 27,507 participants. Completed in 31 August 2020.

Timeline

6 May 2019

Primary endpoint
31 August 2020

31 August 2020

Quick facts

Lead sponsor	University of Cape Town
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	27,507
Start date	6 May 2019
Primary completion	31 August 2020
Estimated completion	31 August 2020
Sites	1 location across South Africa

Drugs / interventions tested

• Increased postoperative surveillance
• Usual postoperative care

Conditions studied

• Surgery — all drugs for Surgery →
• Morality — all drugs for Morality →

Sponsor

University of Cape Town

Who can join

18 and older, any sex, with Surgery or Morality. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Enhanced postoperative surveillance versus standard of care to reduce mortality among adult surgical patients in Africa (ASOS-2): a cluster-randomised controlled trial.
   ASOS-2 Investigators. · · 2021 · cited 43× · PMID 34418380 · DOI 10.1016/s2214-109x(21)00291-6
2. Understanding the performance of a pan-African intervention to reduce postoperative mortality: a mixed-methods process evaluation of the ASOS-2 trial.
   Vickery N, Stephens T, du Toit L, van Straaten D, et al · · 2021 · cited 7× · PMID 34446223 · DOI 10.1016/j.bja.2021.07.001