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Study on the effect and mechanism of residual gastric volume on curative effect of laparoscopic sleeve gastric surgery

Study on the effect and mechanism of changes in gastric flora caused by remaining gastric volume on the curative effect of laparoscopic sleeve gastric surgery

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000040020
Enrollment
Unknown
Registered
2020-11-18
Start date
2020-12-01
Completion date
Unknown
Last updated
2021-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

obesity

Interventions

A:The diameter of gastric plastic tube (32fr) and the length from the cutting point to the pylorus (2cm)
B:The diameter of gastric plastic tube (32fr) and the length from the cutting point to the pylorus (6cm)
C:The diameter of gastric plastic tube (36fr) and the length from the cutting point to the pylorus (2cm)
D:The diameter of gastric plastic tube (36fr) and the length from the cutting point to the pylorus (6cm)

Sponsors

The Second Hospital of Anhui Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Surgical indications for simple obese patients: (1) active surgery is recommended for patients with BMI >= 37.5; surgery is recommended for patients with BMI 32.5 to 37.5; surgery is difficult to control after lifestyle change and medical treatment, and meets at least two components of metabolic syndrome or has complications, so surgery can be considered after comprehensive evaluation; 2. The waist circumference of male >=90 cm, female waist >=85 cm, according to imaging examination, central obesity was found. After extensive consultation of multidisciplinary comprehensive treatment cooperation group (MDT), the surgical recommendation level could be raised as appropriate; 3. The age of operation was 16-65 years old; 4. No hearing, vision, language and other functional disorders, no serious physical diseases, no red green blindness, can complete the cognitive test; 5. Education in primary school or above; 6. Approved by ethics committee of the Second Affiliated Hospital of Anhui Medical University and informed consent of patients.

Exclusion criteria

Exclusion criteria: 1. Definite diagnosis of non obese type 1 diabetes mellitus; 2. The function of islet B cells in patients with T2DM has been basically lost; 3. Surgery is not recommended for patients with BMI < 25.0; 4. Gestational diabetes mellitus and some special types of diabetes mellitus; 5. Drug abuse or alcohol addiction or suffering from uncontrollable mental illness; 6. Mental retardation or immaturity of intelligence and uncontrollable behavior; 7. The expectation of operation does not conform to the reality; 8. Those who are not willing to bear the risk of potential complications; 9. Those who can't cooperate with the changes of diet and living habits after operation and have poor compliance. 10. General condition is poor, and it is difficult to tolerate general anesthesia or operation. 11. History of nervous system disease or injury (e.g. dementia, stroke or seizures; 12. History of moderate or severe head injury (loss of consciousness for more than 10 minutes); 13. History of severe mental illness (e.g., schizophrenia or bipolar disorder); and; 14. History of smoking / alcohol / drug dependence; 15. Taking relevant cognitive improvement drugs or accompanied with obvious anxiety, depression and other mental symptoms; 16. Take antibiotics and intestinal probiotics within 1 month before operation.

Design outcomes

Primary

MeasureTime frame
Stomach volume;Cognitive neuropsychology and behavioral assessment;Genome and metabolome analysis of the microbial flora in the stomach;Clinical efficacy;

Countries

China

Contacts

Public ContactBen-li Jia

The Second Hospital of Anhui Medical University

jbl1985@163.com+86 15955173101

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026