NCT04822519

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
166

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 30, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

May 26, 2022

Status Verified

March 1, 2021

Enrollment Period

1 year

First QC Date

March 12, 2021

Last Update Submit

May 20, 2022

Conditions

Keywords

Risk factors ,gallbladder stone

Outcome Measures

Primary Outcomes (1)

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

    15 weeks

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Adult patients who have gall bladder stone(s)

You may not qualify if:

  • Child -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Sohag, Egypt

Location

MeSH Terms

Conditions

Gallstones

Condition Hierarchy (Ancestors)

CholelithiasisBiliary Tract DiseasesDigestive System DiseasesCholecystolithiasisGallbladder DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident in Tropical Medicine and Gastroenterology Department

Study Record Dates

First Submitted

March 12, 2021

First Posted

March 30, 2021

Study Start

April 1, 2021

Primary Completion

April 1, 2022

Study Completion

May 1, 2022

Last Updated

May 26, 2022

Record last verified: 2021-03

Locations