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NCT05557669

Effect of Laparoscopic Cholecystectomy on Risk of Metabolic Syndrome

Status unknown NA Last updated 28 September 2022
What this trial tests

NA trial testing Laparoscopic cholecystectomy in Cholelithiasis in 400 participants. Status unknown.

Timeline
17 February 2021
Primary endpoint
30 March 2025
30 March 2025

Quick facts

Lead sponsorBrothers Hospitallers Hospital in Cracow
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposebasic science
Enrollment400
Start date17 February 2021
Primary completion30 March 2025
Estimated completion30 March 2025
Sites1 location across Poland

Drugs / interventions tested

Conditions studied

Sponsor

Brothers Hospitallers Hospital in Cracow

Who can join

Adults 18 to 75, any sex, with Cholelithiasis or Metabolic Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. UEG Week 2023 Poster Presentations
    · 2023

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Other trials of Laparoscopic cholecystectomy

Trials testing the same drug.

Other recruiting trials for Cholelithiasis

Currently open trials in the same condition.

Other Brothers Hospitallers Hospital in Cracow trials

Trials by the same sponsor.

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Data sources for this page

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