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临床试验/NCT05557669
NCT05557669招募中不适用

Effect of Laparoscopic Cholecystectomy on Risk of Metabolic Syndrome

Brothers Hospitallers Hospital in Cracow2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2021年2月17日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
400
试验地点
2
主要终点
incidence of triglyceridemia

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • cholelithiasis

排除标准

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

结局指标

主要结局

incidence of triglyceridemia

时间窗: 3 months

serum triglycerides level in mg/dl: more or equal 150 mg/dl

incidence of dyslipidemia

时间窗: 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

时间窗: 3 months

blood preassure in mm Hg: more or equal 130 mm Hg/more or equal 85 mm Hg

incidence of glucose intolerance

时间窗: 3 months

fasting serum glucose in mg/dl: more or equal 100 mg/dl

Risk of the metabolic syndrome in patients undergoing laparoscopic cholecystectomy

时间窗: 3 months

Evaluated with the rNCEP criteria for metabolic syndrome.

incidence of central obesity

时间窗: 3 months

waist circumference in cm: men more or equal 102 cm; women more or equal 88 cm

次要结局

未报告次要终点

研究者

发起方
Brothers Hospitallers Hospital in Cracow
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zofia Orzeszko

Principal Investigator

Brothers Hospitallers Hospital in Cracow

研究点 (2)

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