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Enrolling by invitation

NCT Number: NCT07804290

Quality of Recovery and Patient Satisfaction After Metabolic Surgery at a Tertiary Hospital in Gauteng (QoRPS-MS)

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.

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Key information

Conditions

Obesity Behavior Body Weight Health Behavior Metabolic Disease Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity (Disorder) Overnutrition Overweight Pathological Conditions, Signs and Symptoms Patient Satisfaction Signs and Symptoms Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dr George Mukhari Hospital

Ga-Rankuwa, Gauteng, 0204, South Africa

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  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.

    Time frame: Enrolment will be postoperative day 1.

    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.

  2. To assess satisfaction with anaesthesia care after metabolic surgery at a tertiary institution.

    Time frame: Enrolment will be postoperative day 1.

    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.

  3. To compare quality of recovery with patient satisfaction in patients undergoing metabolic surgery at a tertiary institution.

    Time frame: Enrolment from postoperative day 1.

    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.

Sponsors and collaborators

Lead sponsor

Sefako Makgatho Health Sciences University

Other

Registry information

Acronym: QoRPS-MS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 4, 2026
Registry last updated
Sep 4, 2026

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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