The Risk Factors of Symptomatic Gallbladder Stone: Age-Sex Matched Case-control Study Performed in Single Institute

Completed

• Conditions: Gallstone

• Registration Number: NCT02808546
• Lead Sponsor: Cheju Halla General Hospital

Brief Summary

The main purpose of this study is to investigate the region-specific cause of gallbladder stone incidence in Jeju Self-Governing Province, Korea.

Detailed Description

Investigators performed the epidemiologic study to uncover the reason of relatively higher incidence of Gallbladder cancer in small isolated island, Jeju island, one of small province among 11 self governing area in South Korea. Tow studies, including descriptive epidemiology and analytic epidemiology using case-control study, some risk factors were obtained regarding Gallbladder cancer development in this area. Old age, female, and gallstone were potential risk factors and alcohol consumption was preventive factors. So authors decided to evaluate the relationship between alcohol and gallbladder stone in order to how much portion of causal relationship they have with gallbladder cancer. So this study was designed to investigate the relationship between gallbladder stone and alcohol consumption then performed clinical based case-control study with age-sex matching to each subjects.

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2013-12
• Study Completion: 2015-12
• Status Verified: 2016-06
• Study First Submitted: 2016-06-15
• Study First Submitted QC: 2016-06-17
• Last Update Submitted: 2016-06-17
• Study First Posted: 2016-06-21
• Last Update Posted: 2016-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 342

Inclusion Criteria

• Clinical diagnosis of gallstone disease after cholecystectomy.

Exclusion Criteria

• Ambiguous diagnosis cases for gallbladder stone.
• Incomplete medical record.

Control group

Inclusion Criteria

• Healthy examinees in Health Promotion Center in same Institute
• Eligible cases of abdominal ultrasound(US) or computed tomography(CT)

Exclusion Criteria

• The case who was diagnosed as asymptomatic gallstone on abdominal US

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Alcohol consumption	Through study completion, an average of 1 year	Standard Dose Drink per week was used to compare the amount of alcohol consumption of each subjects

Secondary Outcome Measures

Name	Time	Method
Obesity	Through study completion, an average of 1 year	Obesity was defined as cases were scored more than 25 kg/square meter of Body Mass Index