NCT05557669

Effect of Laparoscopic Cholecystectomy on Risk of Metabolic Syndrome

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Brothers Hospitallers Hospital in Cracow · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

Prospective cohort study. POPULATION: patients with gallstone disease qualified for laparoscopic cholecystectomy INTERVENTION: patients undergoing cholecystectomy for gallstones COMPARISON: gallstone disease without surgery in an observation period OUTCOME: metabolic syndrome symptoms evaluated in 3 months period The main inclusion criteria is cholelithiasis confirmed by ultrasound examination in patients between 18-75 years old. The main exclusion criteria are metabolic syndrome, diabetes, thyroid diseases, pancreatic diseases, serious abdominal surgeries in the past, pregnancy, and lactation. Participants who qualified for laparoscopic cholecystectomy in 3 months are included in the investigation group. Those not having cholecystectomy planned in the upcoming three months for any reason (no consent for surgery, long term) are included in the control group. The intervention is to assess all metabolic syndrome criteria (blood pressure, glucose tolerance, dyslipidemia, abdominal obesity) before and three months after surgery. The endpoint is to evaluate if the risk of metabolic syndrome after cholecystectomy is higher than in patients with gallstones.

Detailed description

Laparoscopic cholecystectomy is well known as a gold standard of treatment for gallstone disease. Gallbladder removal is one of the most common procedures in the United States, with more than 1.2 million cholecystectomies per year, and 92% of the procedures are performed laparoscopically. In 2011 Amigo et al. reported increased triglyceride levels in mice after cholecystectomy. According to Ruhl et al. (2013), cholecystectomy is associated with an increased risk of non-alcoholic fatty liver disease that is considered a liver manifestation of metabolic syndrome. In 2014, Shen et al. published a retrospective study enrolling 5672 participants that demonstrated an increased risk of metabolic syndrome after cholecystectomy compared with gallstone disease alone. Metabolic syndrome (MS) is a disease of civilization. It is a group of disorders containing impaired glucose intolerance, hypertension, abdominal obesity, and dyslipidemia. According to meta-analysis, individuals reaching the criteria of metabolic syndrome have a twice higher risk of myocardial infarction or stroke and a 1,5-times higher risk of death for any reason. The study aims to assess the risk of metabolic syndrome after laparoscopic cholecystectomy prospectively.

Conditions

• Cholelithiasis
• Metabolic Syndrome

Interventions

Type	Name	Description
PROCEDURE	Laparoscopic cholecystectomy	Laparoscopic cholecystectomy is a procedure of removal of the gallbladder and a gold standard in treatment of gallstone disease.

Timeline

• Start date: 2021-02-17
• Primary completion: 2025-03-30
• Completion: 2025-03-30
• First posted: 2022-09-28
• Last updated: 2022-09-28

Locations

1 site across 1 country: Poland