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Trials / Completed

CompletedNCT04822519

RISK FACTORS OF GALL BLADDER STONE

RISK FACTORS OF GALL BLADDER STONE FORMATION

Status
Completed
Phase
Study type
Observational
Enrollment
166 (actual)
Sponsor
Sohag University · Academic / Other
Sex
All
Age
18 Years – 90 Years
Healthy volunteers
Accepted

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

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 .

Conditions

Timeline

Start date
2021-04-01
Primary completion
2022-04-01
Completion
2022-05-01
First posted
2021-03-30
Last updated
2022-05-26

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT04822519. Inclusion in this directory is not an endorsement.