The South African Collaborative Surgical Outcomes Study (SACSOS)

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSefako Makgatho Health Sciences University

About this trial

Improving quality of perioperative care depends on reliable measurement of clinically important and patient-centred data, that will allow collaborative decision-making between patient and clinician. The use of digital health tools to share person-centric data with the aim of improving quality of care is encouraged by the World Health Organization Global Strategy on Digital Health. With virtual and online communication becoming a universal feature of modern life, there is a promising opportunity to engage patients and clinicians in perioperative data collection using digital health platforms. The Perioperative Shared Health Record (PSHR), developed by Safe Surgery South Africa, provides the opportunity to capture standardised patient-centric postoperative outcomes measures, like Quality of Recovery (QOR), Health Related Quality of Life (HRQOL), the WHO Disability Assessment Schedule (WHODAS). These are all standardised measures and questionnaires, which have been recommended by working groups focused on the patient's experience after surgery. The PSHR enables sharing of data between the surgical patient and his/her clinical team (surgeons and anaesthetists).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients presenting for any surgical procedure at South African hospitals during the specified study period.

Disqualifiers

Patients unable to provide consent to participation.

Patients whose legal guardian is unable to provide consent to participation (if applicable).

Patients unable to nominate next-of-kin, guardian of or a person of their choice, as their representative during follow-up.

Trial population

To enable a patient-centred approach, patients will be invited to participate in the study by a member of the clinical team responsible for their care. Initially, clinical teams in the South African private health care sector will be approached. In later phases of the study, recruitment will include eligible patients in the South African public health care sector.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Public or Private Sector Patients

    Other intervention

    No intervention will be done. Two groups of patients will be recruited: patients receiving surgery in the Private Healthcare Sector, and patients receiving surgery in the Public Healthcare Sector

Treatment groups

1,000 Participants
are divided into 2 treatment groups
Group A: Patients within the private healthcare sector1 intervention
Group B: Patients within the public healthcare sector.1 intervention

Trial outcomes

Primary outcomes

1

To describe the relationship between preoperative and 6-month postoperative health-related quality of life in South African surgical patients.

Health Related Quality of Life, measured with the EQ-5D-5L score, preoperatively and at 6 months postoperatively

Time frame
6 Months post-operatively

Secondary outcomes

1

To describe the relationship between patient comorbidities, surgical characteristics and postoperative patient- reported outcomes measures (quality of recovery, health-related quality of life).

Quality of recovery (QoR) preoperatively and at 24-48 hours postoperatively

Time frame
24-48 hours postoperatively
2

To assess data quality (accuracy) of the adapted patient-reported POMS by comparison with completed provider POMS.

Amended Postoperative Morbidity Survey (POMS) postoperatively after 5 days

Time frame
5 days postoperatively
3

To compare data quality (completeness) for patient-reported outcomes and provider POMS between public and private sector settings.

POMS recorded by surgeon at discharge from hospital after surgical procedure

Time frame
5-7 days postoperatively

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sefako Makgatho Health Sciences University

Lead sponsor

Medical Research Council, South Africa

Collaborator

University of Cape Town

Collaborator

This trial is not recruiting at the moment. You can still explore other options: