The South African Collaborative Surgical Outcomes Study (SACSOS)

NCT05052021 | Not Yet Recruiting

• 1 other identifier: SMUREC/M/184/2020
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Postoperative Complications

Keywords

Outcome measures; Peri-operative care; Patient-centered care

Outcome Measures

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

  6 Months post-operatively

Secondary Outcomes (3)

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

  24-48 hours postoperatively

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

  5 days postoperatively

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

  5-7 days postoperatively

Study Arms (2)

Patients within the private healthcare sector

Patients from private sector hospitals in South Africa accommodating the use of the Bespoke Surgical Institute (BSI) Deep Health clinical data platform.

Other: Public or Private Sector Patients

Patients within the public healthcare sector.

Patients admitted for surgery at Dr George Mukhari Academic Hospital, Gauteng Department of Health.

Other: Public or Private Sector Patients

Interventions

Public or Private Sector Patients OTHER

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

Patients within the private healthcare sector; Patients within the public healthcare sector.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sefako Makgatho Health Sciences University: lead
• Medical Research Council, South Africa: collaborator
• University of Cape Town: collaborator

Related Links

• Website for Safe Surgery South Africa. Surgery South Africa, a non-profit company (NPC) will act as custodian of data captured using the Perioperative Shared Health Record (PSHR) platform.

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bruce Biccard, PhD

  University of Cape Town

  PRINCIPAL INVESTIGATOR

• Hyla-Louise Kluyts, DMed

  Sefako Makgatho Health Sciences University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyla-Louise Kluyts, DMed

CONTACT

27836803839; hyla.kluyts@smu.ac.za

Charle Steyl, FCA

CONTACT

27848000904; 201710494@swave.smu.ac.za

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: September 22, 2021
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: May 23, 2025

Record last verified: 2025-05