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

Completed

• Conditions: Gallstone; Dyslipidemias
• Interventions: Diagnostic Test: Serum lipid profile

• Registration Number: NCT03804775
• Lead Sponsor: Services Hospital, Lahore

Brief 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.

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.

Study Timeline

• Study Start: 2017-08-01
• Primary Completion: 2018-08-30
• Study Completion: 2018-08-30
• Status Verified: 2019-01
• Study First Submitted: 2019-01-09
• Study First Submitted QC: 2019-01-14
• Last Update Submitted: 2019-01-14
• Study First Posted: 2019-01-15
• Last Update Posted: 2019-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
control group	Serum lipid profile	inpatients with no history of gallstones
case group	Serum lipid profile	patients presenting with gallstone disease

Primary Outcome Measures

Name	Time	Method
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 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 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 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)

Trial Locations

Locations (1)

Services hospital; 🇵🇰 Lahore, Punjab, Pakistan