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Clinical Efficacy and Safety of a Laparoscopic Sleeve Gastrectomy in Obese Patients

T

Tongji University

Status

Completed

Conditions

Obesity

Treatments

Procedure: Laparoscopic sleeve gastrectomy

Study type

Observational

Funder types

Other

Identifiers

NCT04548232
LSG in Obese Patients

Details and patient eligibility

About

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.

Full description

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.

All patients with obesity underwent LSG. A multidisciplinary team evaluated participants with obesity at baseline, 1, 3, 6, 12, 24, and 36 months after LSG. Anthropometrics, Metabolic indicators, sex hormones, menstruation,glucose-lipid metabolic markers, and hepatic steatosis assessed by FibroScan(CAP value and E value) were measured baseline and postoperative.

Enrollment

300 patients

Sex

All

Ages

16 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

300 participants in 2 patient groups

LSG in obese
Description:
Patients with obesity underwent LSG. Divided into simple obese patients (without complications) and obese patients with complications
Treatment:
Procedure: Laparoscopic sleeve gastrectomy
Control group
Description:
healthy individuals with normal BMI

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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