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

June 17, 2016 updated by: Byung Hyo Cha, MD, Cheju Halla General Hospital
The main purpose of this study is to investigate the region-specific cause of gallbladder stone incidence in Jeju Self-Governing Province, Korea.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

342

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Case group was enrolled from the patients who were diagnosed as gallbladder stone disease with definite clinical symptoms and underwent cholecystectomy in Cheju Halla General Hospital, Jeju, Korea during 3 years (2009-2012). And control group was determined as 1:1 age-sex matched subjects selected from the participants without GBS among Health Promotion Center in the same institute and periods.

Description

Case group

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Case Group
All the patients who were diagnosed as gallbladder stone disease with definite clinical symptoms and underwent cholecystectomy in Cheju Halla General Hospital, Jeju, Korea during 2009-2013
Control Group
Control group was determined as 1:1 age-sex matched subjects selected from the participants without GBS among Health Promotion Center in the same institute and periods.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alcohol consumption
Time Frame: 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
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Obesity
Time Frame: 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
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cheju Halla General Hospital

Investigators

  • Principal Investigator: Byung Hyo Cha, M.D., Gastroenterology Consultant

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

June 15, 2016

First Submitted That Met QC Criteria

June 17, 2016

First Posted (Estimate)

June 21, 2016

Study Record Updates

Last Update Posted (Estimate)

June 21, 2016

Last Update Submitted That Met QC Criteria

June 17, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-L01-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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