RISK FACTORS OF GALL BLADDER STONE

RISK FACTORS OF GALL BLADDER STONE FORMATION

Gallbladder disease is a significant health burden in the developed world and its prevalence has risen by more than 20% in the past three decades In the United States, 20-25 million individuals are affected by gallbladder disease, resulting in an average annual treatment cost of $6.2 billion Obesity, diet, rapid weight loss, metabolic syndrome, and conditions such as cirrhosis, Crohn's disease, irritable bowel syndrome, and gallbladder stasis increase the risk of gallstone formation Surgical removal of the gallbladder, cholecystectomy, is the most recommended treatment for gallbladder disease; however, the procedure increases the risk of non-alcoholic fatty liver disease, cirrhosis and metabolic effects

Study Overview

• Status: Completed
• Conditions: Gall Stone

Detailed Description

Gallbladder disease is a significant health burden in the developed world and its prevalence has risen by more than 20% in the past three decades .

In the United States, 20-25 million individuals are affected by gallbladder disease, resulting in an average annual treatment cost of $6.2 billion Obesity, diet, rapid weight loss, metabolic syndrome, and conditions such as cirrhosis, Crohn's disease, irritable bowel syndrome, and gallbladder stasis increase the risk of gallstone formation .

Surgical removal of the gallbladder, cholecystectomy, is the most recommended treatment for gallbladder disease; however, the procedure increases the risk of non-alcoholic fatty liver disease, cirrhosis and metabolic effects .

Oral dissolution therapy using ursodeoxycholic acid is currently one of the leading non-invasive alternative treatments for gallstones. Ursodeoxycholic acid dissolves small cholesterol gallstones by decreasing hepatic secretion of cholesterol and lowering the chances of unsaturated gallbladder bile formation Although oral dissolution therapy has proven to be a safe alternative to cholecystectomy, it has a gallstone recurrence rate of 50%-70% at 12 years post-treatment .

The high incidence rate and treatment cost associated with gallbladder disease have encouraged the search for preventative strategies. In approximately 75% of cases, impaired gallbladder motility results from the accumulation of cholesterol gallstones. Therefore, agents that reduce lipid concentrations or improve gallbladder motility may reduce the need for surgical interventions and/or the use of potentially harmful pharmaceutical products .

• Study Type: Observational
• Enrollment (Actual): 166

Contacts and Locations

Study Locations

• Egypt
  • Sohag, Egypt
    • at the department of tropical medicine and gastroenterology at sohag University Hospital.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study will include all adult patients with gallstones admitted to Tropical Medicine Department, Sohage University Hospital.

Description

Inclusion Criteria:

Adult patients who have gall bladder stone(s)

Exclusion Criteria:

Child -

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The aim of this study is to unravel the mechanisms responsible for the increased risk of gall stone disease.	All patients will be subjected to:- Complete history taking: With stress on:-; Age sex ( female or male ) comorbid condition (diabetes or hypersensitive).; History of taking lipid lowering drugs. Thorough clinical examination: General examination vital sign ( pulse / blood pressure) height ( centimetre) weight ( kilogram ) body mass index( kg / m2) . Abdominal examination ( organomegly / percussion ). Laboratory Investigation: Lipid profile (total cholesterol, triglyceride, HDL, LDL, VLDL(; Abdominal ultrasound.; Thyroid function test.(T3 / T4); Estrogen.; Random blood suger	15 weeks

Collaborators and Investigators

• Sponsor: Sohag University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): April 1, 2022
• Study Completion (Actual): May 1, 2022

Study Registration Dates

• First Submitted: March 12, 2021
• First Submitted That Met QC Criteria: March 29, 2021
• First Posted (Actual): March 30, 2021

Study Record Updates

• Last Update Posted (Actual): May 26, 2022
• Last Update Submitted That Met QC Criteria: May 20, 2022
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Risk factors ,gallbladder stone
• Additional Relevant MeSH Terms: Digestive System Diseases; Urologic Diseases; Urinary Bladder Diseases; Pathological Conditions, Anatomical; Gallbladder Diseases; Biliary Tract Diseases; Urolithiasis; Urinary Calculi; Calculi; Gallstones; Cholelithiasis; Cholecystolithiasis; Urinary Bladder Calculi
• Other Study ID Numbers: Soh-Med-21-03-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No