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

Completed

• Conditions: Obesity
• Interventions: Procedure: Laparoscopic sleeve gastrectomy

• Registration Number: NCT04548232
• Lead Sponsor: Shanghai 10th People's Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2020-09-07
• Study First Submitted QC: 2020-09-07
• Study First Posted: 2020-09-14
• Primary Completion: 2021-12-01
• Study Completion: 2022-01-01
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-10
• Last Update Posted: 2022-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
LSG in obese	Laparoscopic sleeve gastrectomy	Patients with obesity underwent LSG. Divided into simple obese patients (without complications) and obese patients with complications

Primary Outcome Measures

Name	Time	Method
Hepatic steatosis	3 years	hepatic steatosis assessed by FibroScan(CAP value and E value)

Secondary Outcome Measures

Name	Time	Method
SHBG	3 years	sex hormone-binding globulin in nmol/L
DHEAS	3 years	Dehydroepiandrosterone Sulfate (ug/dl)
LDL-C	3 years	low-density lipoprotein cholesterol in mmol/L、
FT	3 years	free testosterone (nmol/L)
Menstrual cycles	3 years	the total number of menstrual periods in the last year
TT	3 years	total testosterone in nmol/L
FINS	3 years	fasting serum insulin in mU/L
Fertility	3 years	sexual function, fertility
Waist/hip Ratio	3 years	WHR=Waist Circumference in centimeter/Hip Circumference in centimeter
FBG	3 years	fasting blood-glucose in mmol/L
ALT	3 years	alanine aminotransferase in U/L
UA	3 years	Uric acid in umol/L
HOMA-IR	3 years	Homeostatic model assessment insulin resistance index=FBG\*FINS/22.5
BMI	3 years	BMI=weight(kg)/height(m)\^2
PBG	3 years	postprandial blood-glucose in mmol/L
PINS	3 years	postprandial insulin in mU/L
AST	3 years	aspartate aminotransferase in U/L
HbA1c (%)，	3 years	Glycated hemoglobin
HDL-C	3 years	Hight-density lipoprotein cholesterol in mmol/L、