Effect of Laparoscopic Cholecystectomy on Risk of Metabolic Syndrome

Brothers Hospitallers Hospital in Cracow

Status: Enrolling

Conditions: Cholelithiasis; Metabolic Syndrome

Treatments: Procedure: Laparoscopic cholecystectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT05557669

1072.6120.25.2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• cholelithiasis

Exclusion criteria

• metabolic syndrome
• obesity
• diabetes
• thyroid disease
• pancreatic disease
• serious abdominal surgeries in the past
• pregnancy, lactation

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Investigation Group

Experimental group

Description:

Patients undergoing laparoscopic cholecystectomy for cholelithiasis

Treatment:

Procedure: Laparoscopic cholecystectomy

Control group

No Intervention group

Description:

Patients with gallstone disease who are not planned for laparoscopic cholecystectomy in upcoming 3 months