RISK FACTORS OF GALL BLADDER STONE

• ClinicalTrials.gov Identifier: NCT04822519
• Recruitment Status: Not yet recruiting
• First Posted: March 30, 2021
• Last Update Posted: March 30, 2021
• Sponsor: Sohag University
• Information provided by (Responsible Party): Sara Elbadry Elrabie, Sohag University

Study Description

Brief 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

Condition or disease
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 Design

• Study Type: Observational
• Estimated Enrollment: 100 participants
• Observational Model: Case-Only
• Time Perspective: Cross-Sectional
• Official Title: RISK FACTORS OF GALL BLADDER STONE FORMATION
• Estimated Study Start Date: May 1, 2021
• Estimated Primary Completion Date: September 1, 2021
• Estimated Study Completion Date: December 1, 2021

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

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:

   1. Lipid profile (total cholesterol, triglyceride, HDL, LDL, VLDL(
   2. Abdominal ultrasound.
   3. Thyroid function test.(T3 / T4)
   4. Estrogen.
   5. Random blood suger

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Probability Sample

Study Population

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

Criteria

Inclusion Criteria:

Adult patients who have gall bladder stone(s)

Exclusion Criteria:

Child -

Contacts and Locations

Contacts

Contact: Sara Elbadry Elrabie; 01023941334; sara011093@med.sohag.edu.eg

Sponsors and Collaborators

Sohag University

More Information

• Responsible Party: Sara Elbadry Elrabie, Resident in Tropical Medicine and Gastroenterology Department, Sohag University
• ClinicalTrials.gov Identifier: NCT04822519
• Other Study ID Numbers: Soh-Med-21-03-03
• First Posted: March 30, 2021
• Last Update Posted: March 30, 2021
• Last Verified: March 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sara Elbadry Elrabie, Sohag University:

Risk factors ,gallbladder stone

Additional relevant MeSH terms:

Gallstones; Cholelithiasis; Cholecystolithiasis; Urinary Bladder Calculi; Calculi; Pathological Conditions, Anatomical; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases; Urinary Bladder Diseases; Urologic Diseases; Urinary Calculi; Urolithiasis