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

NCT ID: NCT04548232

Last Updated: 2022-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2022-01-01

Brief Summary

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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

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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.

Conditions

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Obesity

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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LSG in obese

Patients with obesity underwent LSG. Divided into simple obese patients (without complications) and obese patients with complications

Laparoscopic sleeve gastrectomy

Intervention Type PROCEDURE

bariatric surgery

Control group

healthy individuals with normal BMI

No interventions assigned to this group

Interventions

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Laparoscopic sleeve gastrectomy

bariatric surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shanghai 10th People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Shen Qu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Wang 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.

Reference Type DERIVED
PMID: 39511506 (View on PubMed)

Ma 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.

Reference Type DERIVED
PMID: 35399676 (View on PubMed)

Other Identifiers

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LSG in Obese Patients

Identifier Type: -

Identifier Source: org_study_id

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