Clinical trial · Observational
Clinical Efficacy and Safety of a Laparoscopic Sleeve Gastrectomy in Obese Patients
Shanghai Tenth People's Hospital，School of Medicine, Tongji University
NCT04548232CI-TRIAL-00060848completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aim to evaluate the clinical efficacy and safety after laparoscopic sleeve gastrectomy in patients with obesity. 300 patients with obesity and 49 healthy individuals with normal BMI were enrolled.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Obesity | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laparoscopic sleeve gastrectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- LSG in obese
- description
- Patients with obesity underwent LSG. Divided into simple obese patients (without complications) and obese patients with complications
- interventionNames
- Procedure: Laparoscopic sleeve gastrectomy
- label
- Control group
- description
- healthy individuals with normal BMI
Primary outcomes (1)
- measure
- Hepatic steatosis
- timeFrame
- 3 years
- description
- hepatic steatosis assessed by FibroScan(CAP value and E value)
Secondary outcomes (19)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1\) age ranged from 16\~65 years old, 2) BMI over 37.5 kg/m2, or BMI over 32.5 kg/m2 with diabetes which meets the recommended cutoff for bariatric surgery of the Guidelines for surgical treatment of obesity accompanied with or without type 2 diabetes in China. - Exclusion Criteria: * 1\) secondary cause of obesity such as hypothalamic obesity, Cushing syndrome, and hypophysis dysfunction, etc., 2) pregnancy or lactation, 3) contraindications for laparoscopic surgery, such as gastrointestinal diseases of intra-abdominal infection, adhesions, etc., 4) severe heart, liver and kidney dysfunction, 5) organic and systemic diseases intolerant of surgery.
References
Publications (3)
- DERIVEDGuo J, Tian P, Yu J, Lu G, Mutailipu K, Wen X, Wang X, You H, Zhu C, Lu L, Wang Y, Qu S, Chen H, Zhuang Y, Bu L. Development and External Validation of a Prediction Model for Hypoxemia After Laparoscopic Sleeve Gastrectomy in Patients with Obesity: a Multicenter Retrospective Study. Obes Surg. 2026 Jun;36(6):2767-2780. doi: 10.1007/s11695-025-07961-y. Epub 2026 Apr 24. PMID 42029999
- DERIVEDWang X, Fang Y, Huang X, Du L, Ren H, Sheng C, Yang P, Huang Y, Qu S. Relationship of serum iron and thyroid hormone in obesity and after laparoscopic sleeve gastrectomy. BMC Endocr Disord. 2024 Nov 7;24(1):240. doi: 10.1186/s12902-024-01753-8. PMID 39511506
- DERIVEDMa B, Yang P, Gao J, Du L, Sheng C, Usman T, Wang X, Qu S. Relationship of Vitamin A and Thyroid Function in Individuals With Obesity and After Laparoscopic Sleeve Gastrectomy. Front Nutr. 2022 Mar 15;9:824193. doi: 10.3389/fnut.2022.824193. eCollection 2022. PMID 35399676