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Effect of Laparoscopic Cholecystectomy on Risk of Metabolic Syndrome

NCT05557669 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2022-09-28

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Laparoscopic cholecystectomy

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

Sponsors & Collaborators

  • Jagiellonian University

    collaborator OTHER

  • Brothers Hospitallers Hospital in Cracow

    lead OTHER

Principal Investigators

  • Mirosław Szura, prof. · Jagiellonian University

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-17
Primary Completion
2025-03-30
Completion
2025-03-30

Countries

  • Poland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05557669 on ClinicalTrials.gov