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Effect of Laparoscopic Cholecystectomy on Risk of Metabolic Syndrome

Effect of Laparoscopic Cholecystectomy on Risk of Metabolic Syndrome

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05557669
Enrollment
400
Registered
2022-09-28
Start date
2021-02-17
Completion date
2025-03-30
Last updated
2022-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholelithiasis, Metabolic Syndrome

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.

Interventions

PROCEDURELaparoscopic cholecystectomy

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

Sponsors

Jagiellonian University
CollaboratorOTHER
Brothers Hospitallers Hospital in Cracow
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

* cholelithiasis

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Risk of the metabolic syndrome in patients undergoing laparoscopic cholecystectomy3 monthsEvaluated with the rNCEP criteria for metabolic syndrome.
incidence of central obesity3 monthswaist circumference in cm: men more or equal 102 cm; women more or equal 88 cm
incidence of triglyceridemia3 monthsserum triglycerides level in mg/dl: more or equal 150 mg/dl
incidence of dyslipidemia3 monthsserum high-density lipo-protein (HDL) level in md/dl: men less than 40 mg/dl; women less than 50 mg/dl
incidence of systemic hypertension3 monthsblood preassure in mm Hg: more or equal 130 mm Hg/more or equal 85 mm Hg
incidence of glucose intolerance3 monthsfasting serum glucose in mg/dl: more or equal 100 mg/dl

Countries

Poland

Contacts

Primary ContactZofia Orzeszko
zosia.orzeszko@icloud.com+48123797148
Backup ContactTomasz Gach, PhD
tomasz.gach@uj.edu.pl+48123797145

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026