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Completed

NCT Number: NCT04822519

RISK FACTORS OF GALL BLADDER STONE

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

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Sohag, Egypt

About this study

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 .

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adult patients who have gall bladder stone(s)

Exclusion criteria

Child -

Treatment and study plan

Primary outcomes

  1. The aim of this study is to unravel the mechanisms responsible for the increased risk of gall stone disease.

    Time frame: 15 weeks

    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

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

RISK FACTORS OF GALL BLADDER STONE FORMATION

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 30, 2021
Registry last updated
May 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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