Effect of Laparoscopic Cholecystectomy on Risk of Metabolic Syndrome

Study Overview
=================
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.

Official Title
-----------------
Effect of Laparoscopic Cholecystectomy on Risk of Metabolic Syndrome

Conditions
-----------------
Cholelithiasis, Metabolic Syndrome

Intervention / Treatment
-----------------
* Procedure: Laparoscopic cholecystectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cholelithiasis Exclusion Criteria: metabolic syndrome obesity diabetes thyroid disease pancreatic disease serious abdominal surgeries in the past pregnancy, lactation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigation Group<br>Patients undergoing laparoscopic cholecystectomy for cholelithiasis | Procedure: Laparoscopic cholecystectomy<br>* Laparoscopic cholecystectomy is a procedure of removal of the gallbladder and a gold standard in treatment of gallstone disease.<br>|
| No Intervention: Control group<br>Patients with gallstone disease who are not planned for laparoscopic cholecystectomy in upcoming 3 months | |

What is the study measuring?
-----------------
Primary Outcome Measures

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