Clinical trial NCT06443723: Metabolic Dysfunction Associated Fatty Liver Disease in Long-Term Cholecystectomy Patients
Official title: Metabolic Dysfunction Associated Fatty Liver Disease in Long-Term Cholecystectomy: A Cross-sectional Case-control Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Steatoses
Keywords: Ultrasaund
obesity
cholecystectomy
Lead sponsor: Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Sponsor class: OTHER
First posted: 2024-06-05
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study was to examine the association between metabolic associated fatty liver disease (MAFLD) in participants who had undergone cholecystectomy and those who had not undergone cholecystectomy. MAFLD is defined as hepatic steatosis(with ultrasonography) entity in addition to the presence of overweight or obesity, diabetes mellitus, or evidence of metabolic dysfunction.

In this way, the long-term effects of cholecystectomy surgeries, which are commonly performed in the society and thought to be harmless, will be evaluated.

Detailed description: Cholecystectomy is known to be a harmless operation with low perioperative mortality and morbidity. However, the unexplained increase in metabolic disorders in cholecystectomy patients has led to the need for further investigation of cholecystectomy patients. Non-alcoholic fatty liver disease is an important health problem with an average prevalence of 25% worldwide and serious hepatic and systemic complications. The aim of this study was to examine the association of cholecystectomy with metabolic dysfunction associated fatty liver disease (MAFLD), which is an important public health problem in the long-term.

This case-controlled cross-sectional study was planned to evaluate the relationship between patients who had undergone cholecystectomy with MAFLD. MAFLD is defined as hepatic steatosis entity in addition to the presence of overweight or obesity, diabetes mellitus, or evidence of metabolic dysfunction.

The study included 86 participants with cholecystectomy and 63 participants without cholecystectomy. It was planned to compare the participants according to the diagnostic criteria for MAFLD (with or without MAFLD).

Eligibility criteria: Inclusion Criteria:

* who were found to have undergone cholecystectomy at least five years ago,
* who could feed orally and perform activities of daily living
* participants who had not undergone cholecystectomy with similar characteristics were included in the study

Exclusion Criteria:

* those with chronic liver disease
* malignancy or history of malignancy
* in a chemotherapy program
* with active infection
* any organ failure
* pregnancy
* use of drugs that cause steatosis in the liver

Primary outcomes:
measure: diabetes mellitus
timeFrame: through study completion, an average of 4 months
measure: definition of overweight
timeFrame: through study completion, an average of 4 months
measure: Upper limits of waist circumference
timeFrame: through study completion, an average of 4 months
measure: Definition of pre-diabetes
timeFrame: through study completion, an average of 4 months
measure: Blood pressure upper limit
timeFrame: through study completion, an average of 4 months
measure: HDL-cholesterol levels
timeFrame: through study completion, an average of 4 months
measure: Triglyceride levels
timeFrame: through study completion, an average of 4 months
measure: Diagnosis of MAFLD
timeFrame: through study completion, an average of 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
Study officials:
References: