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

Tongji University

Status

Completed

Conditions

Polycystic Ovary Syndrome

Treatments

Procedure: Laparoscopic sleeve Gastrectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT05536583

LSG in PCOS patients

Details and patient eligibility

About

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

Full description

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.

Enrollment

200 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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.,