NCT07804290

Brief 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. 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 4, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2026

Completed
8 months until next milestone

First Posted

Study publicly available on registry

September 4, 2026

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 4, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 4, 2026

Completed
Last Updated

September 4, 2026

Status Verified

September 1, 2026

Enrollment Period

1 year

First QC Date

January 18, 2026

Last Update Submit

September 2, 2026

Conditions

Keywords

Metabolic SurgeryBariatric SurgeryQuality of RecoveryPatient satisfactionPatient-reported outcomesObesity

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    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.

    Enrolment will be postoperative day 1.

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

    Enrolment will be postoperative day 1.

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

    Enrolment from postoperative day 1.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing metabolic surgery.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr George Mukhari Hospital

Ga-Rankuwa, Gauteng, 0204, South Africa

Location

MeSH Terms

Conditions

ObesityMetabolic DiseasesPatient Satisfaction

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Onalenna O Tsime, MBBCh

    Sefako Makgato Health Sciences University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 18, 2026

First Posted

September 4, 2026

Study Start

September 4, 2025

Primary Completion

September 4, 2026

Study Completion

September 4, 2026

Last Updated

September 4, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

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.

Locations