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African Surgical OutcomeS-2 (ASOS-2) Trial

NCT03853824 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27507

Last updated 2020-09-10

No results posted yet for this study

Summary

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.

Conditions

  • Surgery
  • Morality

Interventions

OTHER

Increased postoperative surveillance

Increased postoperative surveillance can include either of the following; i) admission to a higher care ward than had been planned at the time of surgery, ii) an increase in the frequency of nursing observations in the postoperative period, iii) ensuring that the patient is placed in view of the nursing station, and not in a remote location in the postoperative ward, or iv) allowing family members to stay with the patient in the ward in the postoperative period.

OTHER

Usual postoperative care

Participating sites randomised to the control arm will provide usual postoperative care to patients. The care will be left to the discretion of the healthcare providers.

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • University of Cape Town

    lead OTHER

Principal Investigators

  • Bruce M Biccard, MD, PhD · University of Cape Town

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-06
Primary Completion
2020-08-31
Completion
2020-08-31

Countries

  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03853824 on ClinicalTrials.gov