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NCT Number: NCT05052021

The South African Collaborative Surgical Outcomes Study (SACSOS)

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. 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

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).

    Time frame: 24-48 hours postoperatively

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

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

    Time frame: 5 days postoperatively

    Amended Postoperative Morbidity Survey (POMS) postoperatively after 5 days

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

    Time frame: 5-7 days postoperatively

    POMS recorded by surgeon at discharge from hospital after surgical procedure

Study contacts

Contact information is provided by the study sponsor or research team.

Charle Steyl, FCA

CONTACT

[email protected]

27848000904

Hyla-Louise Kluyts, DMed

CONTACT

[email protected]

27836803839

Sponsors and collaborators

Lead sponsor

Sefako Makgatho Health Sciences University

Other

Collaborators

  • Medical Research Council, South Africa
  • University of Cape Town

Registry information

Official study title

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

Acronym: SACSOS

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Sep 22, 2021
Registry last updated
May 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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