ObesityQoRPS-MSNCT07804290
Quality of Recovery and Patient Satisfaction After Metabolic Surgery at a Tertiary Hospital in Gauteng (QoRPS-MS)
An observational study of Obesity and Obesity (Disorder), run by Sefako Makgatho Health Sciences University at 1 site in South Africa.
Trial summary
PURPOSE OF THE STUDY?This study aims to assess patients' quality of recovery and satisfaction after metabolic surgery at a tertiary hospital in South Africa using two validated questionnaires. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Obesity (Disorder), Metabolic Disease
- How many people
- 84 participants
- Where
- 1 siteSouth Africa
- Study dates
- 4 Sep 2025to 4 Sep 2026
- 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: Patients undergoing metabolic surgery.
Who may be able to join
- Adults aged 18 years or older.
- Undergoing elective metabolic surgery at Dr George Mukhari Academic Hospital.
- Able and willing to provide written informed consent.
- Able to complete the study questionnaires.
Who cannot join
- History of a psychiatric illness that may impair completion of the study questionnaires.
- Inability to communicate during the postoperative assessment.
- Life-threatening postoperative complications requiring intensive care or preventing questionnaire completion.
- Postoperative confusion or delirium.
- Incomplete Quality of Recovery-15 (QoR-15) or Bauer Patient Satisfaction Questionnaire responses.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
PURPOSE OF THE STUDY?This study aims to assess patients' quality of recovery and satisfaction after metabolic surgery at a tertiary hospital in South Africa using two validated questionnaires. These assess postoperative comfort, return to normal activities, symptoms such as pain, nausea and vomiting, and satisfaction with perioperative care. WHY HAVE PARTICIPANTS BEEN SELECTED? Adults aged 18 years and older undergoing elective metabolic surgery with a protocol-driven anaesthetic will be eligible. A total of 84 participants will be enrolled. WHEN WILL THE RESEARCH BE CONDUCTED? The study will be conducted from September 2025 to September 2026. HOW WILL PARTICIPATION AFFECT TREATMENT? Participation will not alter planned medical, surgical or anaesthetic care. WHAT WILL PARTICIPANTS BE REQUIRED TO DO? Before surgery, the principal investigator or research assistant will explain the study, answer questions and obtain written informed consent.
Participants will complete the 15-item Quality of Recovery (QoR-15) questionnaire and the Bauer Patient Satisfaction Questionnaire. The QoR-15 assesses aspects of recovery using scores from 0 (worst) to 10 (best). The Bauer questionnaire assesses postoperative symptoms and satisfaction with care. Both questionnaires will be administered before surgery and repeated on the first postoperative day. WILL PERSONAL INFORMATION BE USED? Participant confidentiality and anonymity will be maintained. Names will appear only on consent forms, which will be securely stored by Dr Tsime in accordance with institutional requirements. Demographic and clinical information will be collected in a de-identified form for research purposes.
Read the detailed description
Title: Quality of Recovery and Patient Satisfaction after Metabolic Surgery at a Tertiary Hospital in Gauteng: A Cross-Sectional Study (QoRPS-MS)
Obesity is a major public health challenge in South Africa, with approximately 42% of women and 13% of men classified as obese. Obesity is associated with an increased risk of non-communicable diseases, including hypertension, type 2 diabetes mellitus, and cardiovascular disease. Metabolic surgery, including Roux-en-Y gastric bypass (RYGB) and biliopancreatic diversion with duodenal switch, has demonstrated effectiveness in achieving sustained weight loss and improving obesity-related comorbidities. However, limited evidence is available regarding postoperative quality of recovery and patient satisfaction following metabolic surgery within the South African healthcare setting.
This cross-sectional observational study will evaluate patient-reported quality of recovery and satisfaction among adults who have undergone metabolic surgery at Dr George Mukhari Academic Hospital. Quality of recovery will be assessed using the 15-Item Quality of Recovery (QoR-15) questionnaire, and patient satisfaction will be assessed using the Bauer Patient Satisfaction Questionnaire. Data collection will occur during routine postoperative follow-up visits.
Demographic and relevant clinical characteristics will also be collected to explore factors that may influence postoperative recovery and patient satisfaction. Statistical analyses will evaluate QoR-15 scores, Bauer Patient Satisfaction Questionnaire scores, and the relationship between quality of recovery and patient satisfaction.
The findings are expected to improve understanding of patient-reported outcomes following metabolic surgery in a South African tertiary hospital and may identify opportunities to enhance perioperative care and postoperative recovery. The results may also contribute to the optimisation of clinical care pathways and support evidence-based improvements in metabolic surgery services within resource-limited healthcare settings.
- Conditions
- Obesity, Obesity (Disorder), Metabolic Disease
- Keywords
- Metabolic Surgery, Bariatric Surgery, Quality of Recovery, Patient satisfaction, Patient-reported outcomes, Obesity
- Medical subject headings
- Obesity, Metabolic Diseases, Patient Satisfaction
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess patient-reported outcomes using the 15-item Quality of Recovery questionnaire (QoR-15) for patients undergoing metabolic surgery at a tertiary institution.
The QoR-15 is a validated patient-reported outcomes measure with scores ranging from 0 to 150, where higher scores indicate better postoperative recovery. A score >122 is considered good recovery.
Measured: Enrolment from pre-operative (baseline) until Day 1 post-operative.
To assess change in quality of recovery measured using the 15-item Quality of Recovery Questionnaire (QoR-15) for patients undergoing metabolic surgery at a tertiary institution before and after surgery.
Change in quality recovery will be calculated as the difference between the postoperative Day 1 QoR-15 score and the preoperative baseline QoR-15 score. QoR-15 total scores range from 0 to 150, with higher scores indicating better postoperative recovery. A positive change score indicates an improvement in quality of recovery following surgery.
Measured: From baseline preoperative to postoperative day 1.
Secondary outcomes (3)
To assess anaesthesia-related discomfort, using the Bauer questionnaire that is given to patients who undergo metabolic surgery at Dr George Mukhari Academic Hospital.
The first ten questions of the Bauer questionnaire enquire about the presence of symptoms; this data will be split into two categories: either "yes" if the symptom was reported as being present or "no" if not present. The result will be expressed as a percentage per question answered.
Measured: Enrolment will be postoperative day 1.
To assess satisfaction with anaesthesia care after metabolic surgery at a tertiary institution.
The last five questions of the Bauer Questionnaire relate to satisfaction with different aspects of anaesthesia care, which are rated on a 4-point Likert scale. This data will be transformed into two categories, either "Satisfied", which will include "Satisfied" and "Very satisfied", or "Dissatisfied", which will include "Dissatisfied" and "Very dissatisfied". Results will be either satisfied or dissatisfied.
Measured: Enrolment will be postoperative day 1.
To compare quality of recovery with patient satisfaction in patients undergoing metabolic surgery at a tertiary institution.
A further secondary outcome will be comparing mean QoR-15 scores with patient satisfaction in general, using data from the last question of the Bauer questionnaire transformed into two categories, "Satisfied" and "Dissatisfied". If QoR-15 scores are normally distributed, the comparison will be performed with the student t-test. If not normally distributed, non-parametric tests like the Mann-Whitney U test will be used. The null hypothesis for this comparison is that there is no association between QoR-15 scores and overall patient satisfaction.
Measured: Enrolment from postoperative day 1.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start4 Sep 2025
- Primary completion4 Sep 2026 (estimated)
- Study completion4 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sefako Makgatho Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Onalenna Tsime, Sefako Makgatho Health Sciences University
- Investigators
- Onalenna O Tsime, MBBCh, Principal investigator, Sefako Makgato Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07804290
- Sponsor's protocol ID
- SMUREC/M/419/2025:PG
- Acronym
- QoRPS-MS
- Status last verified
- Sep 2026
- First submitted
- 18 Jan 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The questionnaire won't ask for participant identifiers. Since the study solely gathers information about participants' experiences and satisfaction-neither sensitive information nor personal identifiers-individual participant data will not be disclosed. Individual data sharing could jeopardize participant privacy and is not necessary for publishing the overall conclusions. To maintain confidentiality, only aggregated or anonymized findings will be utilized. Every piece of information gathered from the questionnaire will be kept private and used only for this research.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Recovery and Patient Satisfaction After Metabolic Surgery at a Tertiary Hospital in Gauteng (QoRPS-MS)
- ClinicalTrials.gov ID
- NCT07804290
- Acronym / sponsor ID
- QoRPS-MS / SMUREC/M/419/2025:PG
- Conditions
- Obesity, Obesity (Disorder), Metabolic Disease
- Keywords
- Metabolic Surgery, Bariatric Surgery, Quality of Recovery, Patient satisfaction, Patient-reported outcomes, Obesity
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Sefako Makgatho Health Sciences UniversityUniversity, hospital or other
- Study start
- 4 Sep 2025 (actual)
- Primary completion
- 4 Sep 2026 (estimated)
- Study completion
- 4 Sep 2026 (estimated)
- First posted
- 4 Sep 2026 (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.
PURPOSE OF THE STUDY?This study aims to assess patients' quality of recovery and satisfaction after metabolic surgery at a tertiary hospital in South Africa using two validated questionnaires. These assess postoperative comfort, return to normal activities, symptoms such as pain, nausea and vomiting, and satisfaction with perioperative care. WHY HAVE PARTICIPANTS BEEN SELECTED? Adults aged 18 years and older undergoing elective metabolic surgery with a protocol-driven anaesthetic will be eligible. A total of 84 participants will be enrolled. WHEN WILL THE RESEARCH BE CONDUCTED? The study will be conducted from September 2025 to September 2026. HOW WILL PARTICIPATION AFFECT TREATMENT? Participation will not alter planned medical, surgical or anaesthetic care. WHAT WILL PARTICIPANTS BE REQUIRED TO DO? Before surgery, the principal investigator or research assistant will explain the study, answer questions and obtain written informed consent.
Participants will complete the 15-item Quality of Recovery (QoR-15) questionnaire and the Bauer Patient Satisfaction Questionnaire. The QoR-15 assesses aspects of recovery using scores from 0 (worst) to 10 (best). The Bauer questionnaire assesses postoperative symptoms and satisfaction with care. Both questionnaires will be administered before surgery and repeated on the first postoperative day. WILL PERSONAL INFORMATION BE USED? Participant confidentiality and anonymity will be maintained. Names will appear only on consent forms, which will be securely stored by Dr Tsime in accordance with institutional requirements. Demographic and clinical information will be collected in a de-identified form for research purposes.
Detailed description
Title: Quality of Recovery and Patient Satisfaction after Metabolic Surgery at a Tertiary Hospital in Gauteng: A Cross-Sectional Study (QoRPS-MS)
Obesity is a major public health challenge in South Africa, with approximately 42% of women and 13% of men classified as obese. Obesity is associated with an increased risk of non-communicable diseases, including hypertension, type 2 diabetes mellitus, and cardiovascular disease. Metabolic surgery, including Roux-en-Y gastric bypass (RYGB) and biliopancreatic diversion with duodenal switch, has demonstrated effectiveness in achieving sustained weight loss and improving obesity-related comorbidities. However, limited evidence is available regarding postoperative quality of recovery and patient satisfaction following metabolic surgery within the South African healthcare setting.
This cross-sectional observational study will evaluate patient-reported quality of recovery and satisfaction among adults who have undergone metabolic surgery at Dr George Mukhari Academic Hospital. Quality of recovery will be assessed using the 15-Item Quality of Recovery (QoR-15) questionnaire, and patient satisfaction will be assessed using the Bauer Patient Satisfaction Questionnaire. Data collection will occur during routine postoperative follow-up visits.
Demographic and relevant clinical characteristics will also be collected to explore factors that may influence postoperative recovery and patient satisfaction. Statistical analyses will evaluate QoR-15 scores, Bauer Patient Satisfaction Questionnaire scores, and the relationship between quality of recovery and patient satisfaction.
The findings are expected to improve understanding of patient-reported outcomes following metabolic surgery in a South African tertiary hospital and may identify opportunities to enhance perioperative care and postoperative recovery. The results may also contribute to the optimisation of clinical care pathways and support evidence-based improvements in metabolic surgery services within resource-limited healthcare settings.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing metabolic surgery.
Key inclusion criteria (4 listed)
- Adults aged 18 years or older.
- Undergoing elective metabolic surgery at Dr George Mukhari Academic Hospital.
- Able and willing to provide written informed consent.
- Able to complete the study questionnaires.
Key exclusion criteria (5 listed)
- History of a psychiatric illness that may impair completion of the study questionnaires.
- Inability to communicate during the postoperative assessment.
- Life-threatening postoperative complications requiring intensive care or preventing questionnaire completion.
- Postoperative confusion or delirium.
- Incomplete Quality of Recovery-15 (QoR-15) or Bauer Patient Satisfaction Questionnaire responses.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To assess patient-reported outcomes using the 15-item Quality of Recovery questionnaire (QoR-15) for patients undergoing metabolic surgery at a tertiary institution.
Time frame: Enrolment from pre-operative (baseline) until Day 1 post-operative.
The QoR-15 is a validated patient-reported outcomes measure with scores ranging from 0 to 150, where higher scores indicate better postoperative recovery. A score >122 is considered good recovery.
To assess change in quality of recovery measured using the 15-item Quality of Recovery Questionnaire (QoR-15) for patients undergoing metabolic surgery at a tertiary institution before and after surgery.
Time frame: From baseline preoperative to postoperative day 1.
Change in quality recovery will be calculated as the difference between the postoperative Day 1 QoR-15 score and the preoperative baseline QoR-15 score. QoR-15 total scores range from 0 to 150, with higher scores indicating better postoperative recovery. A positive change score indicates an improvement in quality of recovery following surgery.
3 secondary outcomes
To assess anaesthesia-related discomfort, using the Bauer questionnaire that is given to patients who undergo metabolic surgery at Dr George Mukhari Academic Hospital.
Time frame: Enrolment will be postoperative day 1.
To assess satisfaction with anaesthesia care after metabolic surgery at a tertiary institution.
Time frame: Enrolment will be postoperative day 1.
To compare quality of recovery with patient satisfaction in patients undergoing metabolic surgery at a tertiary institution.
Time frame: Enrolment from postoperative day 1.
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 4 Sep 2026.
- Individual participant dataSharing planned: No. The questionnaire won't ask for participant identifiers. Since the study solely gathers information about participants' experiences and satisfaction-neither sensitive information nor personal identifiers-individual participant data will not be disclosed. Individual data sharing could jeopardize participant privacy and is not necessary for publishing the overall conclusions. To maintain confidentiality, only aggregated or anonymized findings will be utilized. Every piece of information gathered from the questionnaire will be kept private and used only for this research.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
Onalenna O Tsime, MBBCh principal investigator
Sefako Makgato Health Sciences University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Obesity (Disorder), run by Sefako Makgatho Health Sciences University at 1 site in South Africa.
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 4 inclusion and 5 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: enrolling by invitation, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess patient-reported outcomes using the 15-item Quality of Recovery questionnaire (QoR-15) for patients undergoing metabolic surgery at a tertiary institution. (time frame: Enrolment from pre-operative (baseline) until Day 1 post-operative.). The study lists 2 primary outcomes in all. 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 4 Sep 2026.