Establishment of a Classification System and Postoperative Risk Warning Model for Patients Undergoing Bariatric Metabolic Surgery for Severe Obesity
Recruiting · NCT07093502 · Observational (researchers observe without assigning treatment) · Lead sponsor: The Third Xiangya Hospital of Central South University
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Inclusion criteria
- Patients who meet the clinical indications for bariatric/metabolic surgery;
- Adults aged 18 to 50 years; ③ Stable body weight (change within ±5% over the past 3 months); ④ Undergoing either laparoscopic sleeve gastrectomy (LSG) or laparoscopic Roux-en-Y gastric bypass (LRYGB).
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);
- Patients currently participating in other clinical studies that may conflict with this study or those who refuse to sign the informed consent form.
Where it is running
1 location listed.
- Third Xiangya Hospital of Central South University - Changsha, Hunan, China