Clinical Efficacy and Safety of Laparoscopic Sleeve Gastrectomy in Obese Patients With PCOS

NCT ID: NCT05536583

Last Updated: 2022-10-03

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

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-01

Study Completion Date

2021-12-31

Brief Summary

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This study aims to evaluate the clinical efficacy and safety in obese patients with Polycystic Ovary Syndrome after laparoscopic sleeve gastrectomy.

Detailed Description

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This study aims to evaluate the clinical efficacy and safety of laparoscopic sleeve gastrectomy in obese patients with Polycystic Ovary Syndrome(PCOS). About 100 obese patients with PCOS and 100 simple obese patients (without complications) were enrolled.

All PCOS 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 were measured baseline and postoperative.

Conditions

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Polycystic Ovary Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Comparison of obese patients with PCOS and simple obesity after laparoscopic sleeve gastrectomy
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PCOS group

Obese Patients with PCOS underwent LSG

Group Type EXPERIMENTAL

Laparoscopic sleeve Gastrectomy

Intervention Type PROCEDURE

Laparoscopic sleeve Gastrectomy

Control group

Sample obese patients without PCOS underwent LSG

Group Type ACTIVE_COMPARATOR

Laparoscopic sleeve Gastrectomy

Intervention Type PROCEDURE

Laparoscopic sleeve Gastrectomy

Interventions

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Laparoscopic sleeve Gastrectomy

Laparoscopic sleeve Gastrectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* age ranged from 18\~45 years old,
* 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

* outside of the 18-45 age range;
* secondary obesity caused by endocrine disorders;
* history of more than one bariatric procedure;
* severe hepatic, renal or heart dysfunction;
* mental illnesses or intellectual disability.
* pregnancy or lactation
* contraindications for laparoscopic surgery, such as gastrointestinal diseases of intra-abdominal infection, adhesions, etc.,
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Shanghai 10th People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhang Manna

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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LSG in PCOS patients

Identifier Type: -

Identifier Source: org_study_id

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