Postoperative ComplicationsSACSOSNCT05052021
The South African Collaborative Surgical Outcomes Study (SACSOS)
An observational study of Postoperative Complications, run by Sefako Makgatho Health Sciences University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- Public or Private Sector Patients
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adult patients presenting for any surgical procedure at South African hospitals during the specified study period.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective Observational Cohort Study of Patient-reported Outcomes After Surgery Using a Digital Health Platform
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).
Read the 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.
- Conditions
- Postoperative Complications
- Being tested
- Public or Private Sector Patients
- Keywords
- Outcome measures, Peri-operative care, Patient-centered care
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Public or Private Sector PatientsOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Public or Private Sector Patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
Quality of recovery (QoR) preoperatively and at 24-48 hours postoperatively
Measured: 24-48 hours postoperatively
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
Measured: 5 days postoperatively
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
Measured: 5-7 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start1 Jun 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sefako Makgatho Health Sciences University
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council, South Africa, University of Cape Town
- Responsible party
- Principal investigator, Hyla-Louise Kluyts, Sefako Makgatho Health Sciences University
- Investigators
- Bruce Biccard, PhD, Principal investigator, University of Cape TownHyla-Louise Kluyts, DMed, Principal investigator, Sefako Makgatho Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05052021
- Sponsor's protocol ID
- SMUREC/M/184/2020
- Acronym
- SACSOS
- Status last verified
- May 2025
- First submitted
- 14 Sep 2021
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Cohort Study of Patient-reported Outcomes After Surgery Using a Digital Health Platform
- ClinicalTrials.gov ID
- NCT05052021
- Acronym / sponsor ID
- SACSOS / SMUREC/M/184/2020
- Conditions
- Postoperative Complications
- Keywords
- Outcome measures, Peri-operative care, Patient-centered care
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Sefako Makgatho Health Sciences UniversityUniversity, hospital or other
- Collaborators
- Medical Research Council, South Africa, University of Cape Town
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 22 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients within the private healthcare sector | – | Other: Public or Private Sector PatientsPatients from private sector hospitals in South Africa accommodating the use of the Bespoke Surgical Institute (BSI) Deep Health clinical data platform. |
| Patients within the public healthcare sector. | – | Other: Public or Private Sector PatientsPatients admitted for surgery at Dr George Mukhari Academic Hospital, Gauteng Department of Health. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Adult patients presenting for any surgical procedure at South African hospitals during the specified study period.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Public or Private Sector PatientsNo 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 | Other | Patients within the private healthcare sector, Patients within the public healthcare sector. |
Primary outcome
To describe the relationship between preoperative and 6-month postoperative health-related quality of life in South African surgical patients.
Time frame: 6 Months post-operatively
Health Related Quality of Life, measured with the EQ-5D-5L score, preoperatively and at 6 months postoperatively
3 secondary outcomes
To describe the relationship between patient comorbidities, surgical characteristics and postoperative patient- reported outcomes measures (quality of recovery, health-related quality of life).
Time frame: 24-48 hours postoperatively
To assess data quality (accuracy) of the adapted patient-reported POMS by comparison with completed provider POMS.
Time frame: 5 days postoperatively
To compare data quality (completeness) for patient-reported outcomes and provider POMS between public and private sector settings.
Time frame: 5-7 days postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bruce Biccard, PhD principal investigator
University of Cape Town
Hyla-Louise Kluyts, DMed principal investigator
Sefako Makgatho Health Sciences University
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Complications, run by Sefako Makgatho Health Sciences University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hyla-Louise Kluyts, DMed (27836803839, hyla.kluyts@smu.ac.za), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To describe the relationship between preoperative and 6-month postoperative health-related quality of life in South African surgical patients. (time frame: 6 Months post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.