Comparative Analysis of Serum Lipid Profiles in Patients With and Without Gallstones

NCT03804775 — Completed, 100 participants, Services Hospital, Lahore

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Comparative Analysis of Serum Lipid Profiles in Patients With and Without Gallstones: A Prospective Cross-Sectional Study

Registry	NCT03804775
Status	Completed
Study type	Observational
Enrollment	100 (Actual)
Sponsor	Services Hospital, Lahore (Other gov)
Conditions	Gallstone, Dyslipidemias
Interventions	Serum lipid profile (Diagnostic test)
Dates	start 2017-08-01, primary completion 2018-08-30, completion 2018-08-30, first posted 2019-01-15, last updated 2019-01-15
Locations	1 site in Pakistan

-Summary

Gallbladder disease is one of the most common diseases of the gastrointestinal tract. Various studies have shown an association between gallstones and an alteration in the serum lipids. The objective of this study will be to compare serum lipid profile of gallstone patients with the controls.

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+Detailed description

This prospective cross-sectional study will be conducted in the Surgical Department of the Services Institute of Medical Sciences. A total of 50 patients will beincluded in the study after screening through the inclusion criteria. A control group of 50 inpatients with no personal or family history of gallstones will be also recruited for comparison. Results will be expressed as mean with standard deviation. Students t- test will be used to compare the data between the patients and the control groups (p<0.05 will be considered statistically significant). SPSS software, version 20 will be used for statistical analysis.

+Arms and interventions

Arm	Type	Interventions	Description
case group		Diagnostic Test: Serum lipid profile	patients presenting with gallstone disease
control group		Diagnostic Test: Serum lipid profile	inpatients with no history of gallstones

Serum lipid profile (Diagnostic test): Blood samples drawn from the patients and controls will be analyzed for serum cholesterol, serum triglycerides, serum LDLs and serum HDL levels. All the results will be recorded on a performa

+Outcome measures

Primary outcomes

serum cholesterol levels [1 week]: serum cholesterol levels of patients and case group will be compared with Students t- test was (p<0.05 will be considered statistically significant)
serum triglyceride levels [1 week]: serum triglyceride levels of gallstone patients and control group will be compared via student t-test (p<0.05 was considered statistically significant)
serum HDL levels [1 week]: serum HDL levels of patients and contoled will be compared with student t-test (p<0.05 was considered statistically significant)
serum LDL leves [1 week]: serum LDL leves of patients and control will be compared through student t-test (p<0.05 was considered statistically significant)

+Eligibility

Sex: All, ages: 20 Years to 70 Years

Inclusion Criteria:

* Male or female patients with the gall stone disease
* Age from 20 to 70 years
* Gallstones were diagnosed through the ultrasound

Exclusion Criteria:

* Patients with acalculous gallbladder disease on ultrasound,
* Patients with terminal ileal resection,
* Patients with hemolytic diseases (hereditary spherocytosis, sickle cell anemia on history and CBC film),
* Patients with liver cirrhosis (on abdominal ultrasound) and
* Patients on antihyperlipidemic drugs

+Locations (1)

Facility	City	Country	Status
Services hospital	Lahore, Punjab Province	Pakistan

+Investigators

Mahmmood Ayyaz, mbbs, fcps, Study director, Services Hospital, Lahore