African Surgical OutcomeS-2 (ASOS-2) Trial

NCT03853824 | Completed

• 1 other identifier: ASOS-2
• Study Type: interventional
• Target: 27,507
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• In hospital mortality.

  Number of Participants with In hospital mortality

  In-hospital, and censored at 30 days after surgery if still in-hospital.

Secondary Outcomes (1)

• Composite of severe in-hospital complications and mortality

  In-hospital, and censored at 30 days after surgery if still in-hospital.

Other Outcomes (7)

• 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.

• In-hospital severe urinary tract or acute kidney injury

  In-hospital, and censored at 30 days after surgery if still in-hospital.

• In-hospital severe bloodstream infection or acute respiratory distress syndrome

  In-hospital, and censored at 30 days after surgery if still in-hospital.

Study Arms (2)

Intervention arm

OTHER

Patients randomised to increased postoperative surveillance.

Other: Increased postoperative surveillance

Control arm

OTHER

Patients randomised to usual postoperative care.

Other: Usual postoperative care

Interventions

Increased postoperative surveillance OTHER

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.

Intervention arm

Usual postoperative care OTHER

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.

Control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All consecutive adult patients aged 18 years and over admitted to participating centres undergoing elective and non-elective surgery

You may not qualify if:

• Prior participation in ASOS-2

Sponsors & Collaborators

• University of Cape Town: lead
• Bill and Melinda Gates Foundation: collaborator

Study Sites (1)

Groote Schuur Hospital

Cape Town, Western Cape, 8001, South Africa

Location

Related Publications (3)

• 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.

  PMID: 29306587 BACKGROUND

• Vickery N, Stephens T, du Toit L, van Straaten D, Pearse R, Torborg A, Rolt L, Puchert M, Martin G, Biccard B; ASOS-2 Investigators. Understanding the performance of a pan-African intervention to reduce postoperative mortality: a mixed-methods process evaluation of the ASOS-2 trial. Br J Anaesth. 2021 Nov;127(5):778-788. doi: 10.1016/j.bja.2021.07.001. Epub 2021 Aug 24.

  PMID: 34446223 DERIVED

• ASOS-2 Investigators. Enhanced postoperative surveillance versus standard of care to reduce mortality among adult surgical patients in Africa (ASOS-2): a cluster-randomised controlled trial. Lancet Glob Health. 2021 Oct;9(10):e1391-e1401. doi: 10.1016/S2214-109X(21)00291-6. Epub 2021 Aug 19.

  PMID: 34418380 DERIVED

Study Officials

• Bruce M Biccard, MD, PhD

  University of Cape Town

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Anaesthetist

Model Details: Participating sites will be randomised to normal postoperative care, or increased postoperative surveillance. Randomisation will be stratified according to the level of the surgical facility and the expected weekly surgical case-load. Participating sites which have been randomised to increased surveillance will need to provide increased surveillance to surgical patients with a predicted increased postoperative risk as determined by the ASOS risk stratification tool. 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.

Study Record Dates

• First Submitted: February 20, 2019
• First Posted: February 26, 2019
• Study Start: May 6, 2019
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: September 10, 2020

Record last verified: 2020-09

Locations

ZA (1)