Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study aims to establish a classification system for patients undergoing metabolic surgery for severe obesity by constructing a prospective cohort of 2,000 patients and collecting clinical and biological data at multiple time points before and after surgery. By analyzing clinical, laboratory, and multi-omics characteristics, the study will identify indicators associated with postoperative adverse events and develop a risk warning model using machine learning algorithms. Ultimately, an intelligent digital system will be developed based on the classification criteria and risk model, integrating surgical classification and risk alert functions to provide real-time feedback, supporting clinicians and patients in optimizing postoperative treatment and risk management.
Establishment of a Prospective Disease-Specific Follow-up Cohort of 2,000 Patients Based on the Following Inclusion and Exclusion Criteria
All participants will undergo metabolic surgery. A prospective, disease-specific follow-up cohort will be established, and baseline data will be collected. Patients will be followed up at multiple postoperative time points: days 3 and 7, and months 1, 3, 6, 12, and 24. Follow-up assessments will include the occurrence of postoperative complications and adverse events, as well as the degree of metabolic improvement and prognosis.
A multidimensional data platform will be used to integrate and analyze diverse indicators, identifying those strongly associated with postoperative adverse events. Clustering analysis will be applied to establish a classification system for patients undergoing metabolic surgery for severe obesity. Targeted assays will be performed on time-series biospecimens to identify novel risk biomarkers. A risk warning model will be constructed, validated, and evaluated. Finally, an intelligent digital system integrating patient classification and real-time risk alert functions will be developed to optimize long-term outcomes and enhance the precision and timeliness of classification and risk warning for healthcare professionals and patients.
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Stratified into Distinct Clusters Using Unsupervised Clustering Algorithm Based on BMI, Comorbidity Count, Inflammatory Markers, and Proteomics Profiles | Participants will be stratified at baseline using an unsupervised clustering algorithm (e.g., k-means) based on the following input variables:（1）Body mass index (BMI, kg/m²)；（2）Comorbidity count (number of chronic diseases at enrollment)；（3）Inflammatory markers (e.g., CRP in mg/L, IL-6 in pg/mL)；（4）Proteomics features (relative expression intensity from LC-MS) The clustering procedure will produce a categorical variable assigning each participant to one of 3-5 data-driven subtypes. The total number of participants in each subtype group will be reported. | From enrollment to the end of follow-up at 2 years |
| Accuracy, Sensitivity, and Specificity of the Postoperative Risk Prediction Model for Adverse Outcomes | Model performance will be assessed for predicting postoperative adverse outcomes within 12 months after bariatric surgery. Predictors include demographic data, intraoperative parameters, early postoperative recovery data, and stratification subtype. Model discrimination will be evaluated using area under the receiver operating characteristic curve (AUC-ROC), and calibration will be assessed with calibration plots and Hosmer-Lemeshow test. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) will be reported using confusion matrix analysis in internal validation (e.g., bootstrapping or 10-fold cross-validation). | Up to 24 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| User Satisfaction Score of the Digital Postoperative Management System Measured by System Usability Scale (SUS) | User experience and satisfaction with the digital management system will be evaluated using the validated 10-item System Usability Scale (SUS). SUS scores range from 0 to 100, with higher scores indicating greater usability. Both patients and clinical staff will be surveyed at 3 months post-deployment. |
Not provided
Inclusion Criteria:
Patients who meet the clinical indications for bariatric/metabolic surgery;
Exclusion Criteria:
① Patients with conditions affecting the immune or metabolic systems (e.g., endocrine disorders such as untreated hypothyroidism/hyperthyroidism, cancer);
Patients with renal or hepatic impairment;
Patients who have taken medications that may affect metabolism within the past 3 months (e.g., weight-loss drugs, asthma medications, psychiatric medications, corticosteroids);
Patients who have previously undergone bariatric surgery and are undergoing revisional surgery; ⑤ Patients with psychiatric disorders, especially those with comorbid behavioral or personality disorders (e.g., binge eating disorder);
Not provided
Not provided
Patients undergoing bariatric/metabolic surgery
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liyong Zhu | Contact | +86 13975879453 | zly8128@csu.edu.cn |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Third Xiangya Hospital of Central South University | Recruiting | Changsha | Hunan | 410013 | China |
Undecided. Data sharing is currently under consideration. The decision will depend on institutional policy, ethical review board approval, and the establishment of appropriate data-use agreements to protect participant confidentiality.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Serum sample；Plasma sample；Adipose tissue；Gastric fundus tissue
| At 24 months after initiation of digital system use |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided