Effect of Laparoscopic Cholecystectomy on Risk of Metabolic Syndrome
Primary Purpose
Cholelithiasis, Metabolic Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Laparoscopic cholecystectomy
Sponsored by
About this trial
This is an interventional basic science trial for Cholelithiasis
Eligibility Criteria
Inclusion Criteria:
- cholelithiasis
Exclusion Criteria:
- metabolic syndrome
- obesity
- diabetes
- thyroid disease
- pancreatic disease
- serious abdominal surgeries in the past
- pregnancy, lactation
Sites / Locations
- Brothers Hospitallers Hospital in CracowRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Investigation Group
Control group
Arm Description
Patients undergoing laparoscopic cholecystectomy for cholelithiasis
Patients with gallstone disease who are not planned for laparoscopic cholecystectomy in upcoming 3 months
Outcomes
Primary Outcome Measures
Risk of the metabolic syndrome in patients undergoing laparoscopic cholecystectomy
Evaluated with the rNCEP criteria for metabolic syndrome.
incidence of central obesity
waist circumference in cm: men more or equal 102 cm; women more or equal 88 cm
incidence of triglyceridemia
serum triglycerides level in mg/dl: more or equal 150 mg/dl
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
incidence of systemic hypertension
blood preassure in mm Hg: more or equal 130 mm Hg/more or equal 85 mm Hg
incidence of glucose intolerance
fasting serum glucose in mg/dl: more or equal 100 mg/dl
Secondary Outcome Measures
Full Information
NCT ID
NCT05557669
First Posted
July 25, 2022
Last Updated
September 27, 2022
Sponsor
Brothers Hospitallers Hospital in Cracow
Collaborators
Jagiellonian University
1. Study Identification
Unique Protocol Identification Number
NCT05557669
Brief Title
Effect of Laparoscopic Cholecystectomy on Risk of Metabolic Syndrome
Official Title
Effect of Laparoscopic Cholecystectomy on Risk of Metabolic Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 17, 2021 (Actual)
Primary Completion Date
March 30, 2025 (Anticipated)
Study Completion Date
March 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brothers Hospitallers Hospital in Cracow
Collaborators
Jagiellonian University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholelithiasis, Metabolic Syndrome
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Investigation Group
Arm Type
Experimental
Arm Description
Patients undergoing laparoscopic cholecystectomy for cholelithiasis
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients with gallstone disease who are not planned for laparoscopic cholecystectomy in upcoming 3 months
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic cholecystectomy
Intervention Description
Laparoscopic cholecystectomy is a procedure of removal of the gallbladder and a gold standard in treatment of gallstone disease.
Primary Outcome Measure Information:
Title
Risk of the metabolic syndrome in patients undergoing laparoscopic cholecystectomy
Description
Evaluated with the rNCEP criteria for metabolic syndrome.
Time Frame
3 months
Title
incidence of central obesity
Description
waist circumference in cm: men more or equal 102 cm; women more or equal 88 cm
Time Frame
3 months
Title
incidence of triglyceridemia
Description
serum triglycerides level in mg/dl: more or equal 150 mg/dl
Time Frame
3 months
Title
incidence of dyslipidemia
Description
serum high-density lipo-protein (HDL) level in md/dl: men less than 40 mg/dl; women less than 50 mg/dl
Time Frame
3 months
Title
incidence of systemic hypertension
Description
blood preassure in mm Hg: more or equal 130 mm Hg/more or equal 85 mm Hg
Time Frame
3 months
Title
incidence of glucose intolerance
Description
fasting serum glucose in mg/dl: more or equal 100 mg/dl
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
cholelithiasis
Exclusion Criteria:
metabolic syndrome
obesity
diabetes
thyroid disease
pancreatic disease
serious abdominal surgeries in the past
pregnancy, lactation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zofia Orzeszko
Phone
+48123797148
Email
zosia.orzeszko@icloud.com
First Name & Middle Initial & Last Name or Official Title & Degree
Tomasz Gach, PhD
Phone
+48123797145
Email
tomasz.gach@uj.edu.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mirosław Szura, prof.
Organizational Affiliation
Jagiellonian University
Official's Role
Study Chair
Facility Information:
Facility Name
Brothers Hospitallers Hospital in Cracow
City
Kraków
State/Province
Lesser Poland
ZIP/Postal Code
31061
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zofia Orzeszko
Phone
+48123797148
Email
z.orzeszko@bonifratrzy.krakow.pl
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26256900
Citation
Barrera F, Azocar L, Molina H, Schalper KA, Ocares M, Liberona J, Villarroel L, Pimentel F, Perez-Ayuso RM, Nervi F, Groen AK, Miquel JF. Effect of cholecystectomy on bile acid synthesis and circulating levels of fibroblast growth factor 19. Ann Hepatol. 2015 Sep-Oct;14(5):710-21.
Results Reference
background
PubMed Identifier
32352682
Citation
Latenstein CSS, Alferink LJM, Darwish Murad S, Drenth JPH, van Laarhoven CJHM, de Reuver PR. The Association Between Cholecystectomy, Metabolic Syndrome, and Nonalcoholic Fatty Liver Disease: A Population-Based Study. Clin Transl Gastroenterol. 2020 Apr;11(4):e00170. doi: 10.14309/ctg.0000000000000170.
Results Reference
background
PubMed Identifier
28892095
Citation
Chen Y, Wu S, Tian Y. Cholecystectomy as a risk factor of metabolic syndrome: from epidemiologic clues to biochemical mechanisms. Lab Invest. 2018 Jan;98(1):7-14. doi: 10.1038/labinvest.2017.95. Epub 2017 Sep 11.
Results Reference
background
PubMed Identifier
29706426
Citation
Di Ciaula A, Garruti G, Wang DQ, Portincasa P. Cholecystectomy and risk of metabolic syndrome. Eur J Intern Med. 2018 Jul;53:3-11. doi: 10.1016/j.ejim.2018.04.019. Epub 2018 Apr 26.
Results Reference
background
PubMed Identifier
29297503
Citation
Garruti G, Wang DQ, Di Ciaula A, Portincasa P. Cholecystectomy: a way forward and back to metabolic syndrome? Lab Invest. 2018 Jan;98(1):4-6. doi: 10.1038/labinvest.2017.129.
Results Reference
background
PubMed Identifier
30770629
Citation
Qi L, Tian Y, Chen Y. Gall bladder: The metabolic orchestrator. Diabetes Metab Res Rev. 2019 Jul;35(5):e3140. doi: 10.1002/dmrr.3140. Epub 2019 Feb 27.
Results Reference
background
PubMed Identifier
26143191
Citation
Tsai MS, Lin CL, Hsu YC, Lee HM, Kao CH. Long-term risk of pancreatitis and diabetes after cholecystectomy in patients with cholelithiasis but no pancreatitis history: a 13-year follow-up study. Eur J Intern Med. 2015 Sep;26(7):540-4. doi: 10.1016/j.ejim.2015.06.013. Epub 2015 Jul 2.
Results Reference
background
PubMed Identifier
31477078
Citation
Yue W, Sun X, Du T. Cholecystectomy versus central obesity or insulin resistance in relation to the risk of nonalcoholic fatty liver disease: the third US National Health and Nutrition Examination Survey. BMC Endocr Disord. 2019 Sep 2;19(1):95. doi: 10.1186/s12902-019-0423-y.
Results Reference
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Effect of Laparoscopic Cholecystectomy on Risk of Metabolic Syndrome
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