RISK FACTORS OF GALL BLADDER STONE

Gall Stone Clinical Trial

Official title:

RISK FACTORS OF GALL BLADDER STONE FORMATION

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04822519
• Other study ID #: Soh-Med-21-03-03
• Status: Completed
• Start date: April 1, 2021
• Est. completion date: May 1, 2022

Study information

• Verified date: March 2021
• Source: Sohag University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: May 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

Adult patients who have gall bladder stone(s)

Exclusion Criteria:

Child -

Related Conditions & MeSH terms

• Calculi
• Cholecystolithiasis
• Cholelithiasis
• Gall Stone
• Gallstones

Locations

Country	Name	City	State
Egypt	at the department of tropical medicine and gastroenterology at sohag University Hospital.	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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