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The South African Collaborative Surgical Outcomes Study (SACSOS)

A Prospective Observational Cohort Study of Patient-reported Outcomes After Surgery Using a Digital Health Platform

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05052021
Acronym
SACSOS
Enrollment
1000
Registered
2021-09-22
Start date
2025-06-01
Completion date
2027-06-30
Last updated
2025-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Complications

Keywords

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

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).

Detailed description

SACSOS is a patient-centered prospective observational cohort study. 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. Patient engagement and -participation will be sought during the recruitment process by engaging with the clinical team (surgeon, anaesthetist, hospital clinical manager) for individual patient care (at a micro level); in data collection using a patient-centric platform; and in the follow up after surgery. Data will be collected by patients using a digital platform, the Perioperative Shared Health Record (PSHR). De-identified data will be extracted from the database at predetermined intervals and made available to the principal investigator for analysis. The PSHR will be updated to optimise health information exchange between the surgical patient and clinical team members during the study. Participation from health care providers will be in a team-based approach, including surgeon(s) and/or anaesthetist(s) at each specific center. A core group of participating centers will be identified. The study will focus on patient participation with the web-based platform as the primary recruitment method. This will reduce the need for clinician input, and promote greater patient-centeredness. Patient participation and data capturing require internet access to the web-based platform.

Interventions

OTHERPublic or Private Sector Patients

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

Sponsors

Medical Research Council, South Africa
CollaboratorOTHER
University of Cape Town
CollaboratorOTHER
Sefako Makgatho Health Sciences University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
To describe the relationship between preoperative and 6-month postoperative health-related quality of life in South African surgical patients.6 Months post-operativelyHealth Related Quality of Life, measured with the EQ-5D-5L score, preoperatively and at 6 months postoperatively

Secondary

MeasureTime frameDescription
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 postoperativelyQuality of recovery (QoR) preoperatively and at 24-48 hours postoperatively
To assess data quality (accuracy) of the adapted patient-reported POMS by comparison with completed provider POMS.5 days postoperativelyAmended Postoperative Morbidity Survey (POMS) postoperatively after 5 days
To compare data quality (completeness) for patient-reported outcomes and provider POMS between public and private sector settings.5-7 days postoperativelyPOMS recorded by surgeon at discharge from hospital after surgical procedure

Contacts

Primary ContactHyla-Louise Kluyts, DMed
hyla.kluyts@smu.ac.za27836803839
Backup ContactCharle Steyl, FCA
201710494@swave.smu.ac.za27848000904

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026