An observational study in Obesity, Obesity (Disorder) and Metabolic Disease, sponsored by Sefako Makgatho Health Sciences University. Enrolling by invitation at 1 site in South Africa. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by Sefako Makgatho Health Sciences University · Observational
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.
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 84 is below the median of 114 across 2,154 observational studies indexed under Obesity.
Browse Obesity studies →Sefako Makgatho Health Sciences University is the lead sponsor of 6 studies on the registry; 3 are open to participants now.
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Patients undergoing metabolic surgery.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Time frame: 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.
Time frame: From baseline preoperative to postoperative day 1.
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.
Time frame: 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.
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.
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.
Time frame: Enrolment from postoperative day 1.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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.
Started Sep 2025 (actual). Primary completion is estimated for Sep 2026, 12 months after the start.
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Sefako Makgatho Health Sciences University