RISK FACTORS OF GALL BLADDER STONE

NCT ID: NCT04822519

Last Updated: 2022-05-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

166 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-01

Study Completion Date

2022-05-01

Brief Summary

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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

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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

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Gall Stone

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

Adult patients who have gall bladder stone(s)

Exclusion Criteria

Child -
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Sara Elbadry Elrabie

Resident in Tropical Medicine and Gastroenterology Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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at the department of tropical medicine and gastroenterology at sohag University Hospital.

Sohag, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Soh-Med-21-03-03

Identifier Type: -

Identifier Source: org_study_id

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