Effect of Laparoscopic Cholecystectomy on Risk of Metabolic Syndrome

Not Applicable

Recruiting

• Conditions: Cholelithiasis; Metabolic Syndrome
• Interventions: Procedure: Laparoscopic cholecystectomy

• Registration Number: NCT05557669
• Lead Sponsor: Brothers Hospitallers Hospital in Cracow

Brief 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.

Study Timeline

• Study Start: 2021-02-17
• Study First Submitted: 2022-07-25
• Status Verified: 2022-09
• Study First Submitted QC: 2022-09-27
• Last Update Submitted: 2022-09-27
• Study First Posted: 2022-09-28
• Last Update Posted: 2022-09-28
• Primary Completion: 2025-03-30
• Study Completion: 2025-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• cholelithiasis

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Investigation Group	Laparoscopic cholecystectomy	Patients undergoing laparoscopic cholecystectomy for cholelithiasis

Primary Outcome Measures

Name	Time	Method
incidence of triglyceridemia	3 months	serum triglycerides level in mg/dl: more or equal 150 mg/dl
incidence of dyslipidemia	3 months	serum high-density lipo-protein (HDL) level in md/dl: men less than 40 mg/dl; women less than 50 mg/dl
incidence of systemic hypertension	3 months	blood preassure in mm Hg: more or equal 130 mm Hg/more or equal 85 mm Hg
incidence of glucose intolerance	3 months	fasting serum glucose in mg/dl: more or equal 100 mg/dl
Risk of the metabolic syndrome in patients undergoing laparoscopic cholecystectomy	3 months	Evaluated with the rNCEP criteria for metabolic syndrome.
incidence of central obesity	3 months	waist circumference in cm: men more or equal 102 cm; women more or equal 88 cm

Trial Locations

Locations (1)

Brothers Hospitallers Hospital in Cracow; 🇵🇱 Kraków, Lesser Poland, Poland