Epidemiology of Inflammatory Bowel Disease in the Songpa-Kangdong District, Seoul, Korea.

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

The purpose of this study is to evaluate the incidence, prevalence, clinical characteristics and prognosis of Crohn's disease and ulcerative colitis over time in a district of Seoul, Korea.

Condition or disease
Crohn's Disease; Ulcerative Colitis; Epidemiology; Korea

Detailed Description:

Inflammatory bowel disease (IBD), which is comprised of Crohn's disease (CD) and ulcerative colitis (UC) is a chronic inflammatory disease of gut with uncertain etiopathogenesis. According to our previous study (Yang, et al. Inflamm Bowel Dis 2008; 14: 542-549), the incidence and prevalence of IBD in Korea are still low compared with those in Western countries, but are rapidly increasing. However, the long-term trends of epidemiology of CD and UC together with their characteristics and prognosis in Korea are uncertain yet. The investigators therefore aim to elucidate the incidence and prevalence of CD and UC over a 30-year period, from 1986 to 2017, in the Songpa-Kangdong district of Seoul, Korea. In addition, the investigators also aim to reveal the clinical features at the time of diagnosis of IBD, long-term evolution of disease and prognosis.

Study Design

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Study Type :	Observational
Estimated Enrollment :	2000 participants
Observational Model:	Cohort
Official Title:	Epidemiology of Inflammatory Bowel Disease in the Songpa-Kangdong District, Seoul, Korea.
Study Start Date :	December 2012
Estimated Primary Completion Date :	December 2017
Estimated Study Completion Date :	June 2018

Groups and Cohorts

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Group/Cohort
The Songpa-Kangdong cohort of IBD; Incident cases of IBD in the Songpa-Kangdong district, a well-defined administrative area in Seoul, the capital of Korea, beginning in 1986, when the first patient with IBD was diagnosed, until 2017. For the prevalent cases, the inhabitants with IBD at Dec 31, 2007 in the Songpa-Kangdong district are included.

Outcome Measures

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Primary Outcome Measures :

1. Incidence rate and prevalence rate of IBD [ Time Frame: 1986-2017 (up to 31 years) ]
   1. Annual incidence rate of Crohn's disease and ulcerative colitis
   2. Prevalence rate of Crohn's disease and ulcerative colitis as of Dec 31, 2017.

Secondary Outcome Measures :

1. Clinical features of patients with IBD [ Time Frame: 1986-2017 (up to 31 years) ]
   1. Clinical characteristics of patients newly diagnosed with Crohn's disease or ulcerative colitis: gender, presenting symptoms, duration between symptoms to diagnosis, and phenotypes, etc.
   2. Clinical course of patients newly diagnosed with Crohn's disease or ulcerative colitis: development of complications (strictures, perforations), intestinal resection rate, hospitalization rate, mortality, and pregnancies and their outcomes
   3. Treatment modalities of IBD and their trends: use of medication (5-ASA, corticosteroids, immunomodulators, and biologic agents, etc.)

Eligibility Criteria

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Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

The study is performed in the Songpa-Kangdong district, a well-defined administrative area in Seoul, the capital of Korea, beginning in 1986, when the first patient with IBD was diagnosed, until 2017. The population of the study area was racially and ethnically homogeneous and was relatively stable in number.

Criteria

Inclusion Criteria:

• Definite cases of CD and UC

Patients are diagnosed with CD if they meet at least 2 of the following criteria:

1. clinical history of abdominal pain, weight loss, malaise, diarrhea, and/or rectal bleeding
2. endoscopic findings of mucosal cobblestoning, linear ulceration, skip areas, or perianal disease
3. radiologic findings of stricture, fistula, mucosal cobblestoning, or ulceration
4. macroscopic appearance of bowel wall induration, mesenteric lymphadenopathy, and "creeping fat" at laparotomy
5. pathologic findings of transmural inflammation and/or epithelioid granulomas

Only patients who meet these criteria for at least 2 months are included.

Patients are diagnosed with UC only if all 3 of the following criteria are present

1. a typical history of diarrhea or blood and pus or both in the stool for longer than 4 weeks
2. a typical sigmoidoscopic or colonoscopic picture with diffusely granular, friable, or ulcerated mucosa without rectal sparing or skip lesions or radiological signs of characteristic continuous granular or ulcerated mucosa
3. characteristic histopathological signs of inflammation on biopsy

Exclusion Criteria:

• IBD unclassified
• Ethnic groups other than Korean

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Suk-Kyun Yang, M.D.	+82-2-3010-3901	sky@amc.seoul.kr
Contact: Byong Duk Ye, M.D.	+82-2-3010-3181	bdye@amc.seoul.kr

Locations

Korea, Republic of
Asan Medical Center	Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Suk-Kyun Yang, M.D. +82-2-3010-3901 sky@amc.seoul.kr
Contact: Byong Duk Ye, M.D. +82-2-3010-3181 bdye@amc.seoul.kr
Principal Investigator: Suk-Kyun Yang, M.D.

Sponsors and Collaborators

Asan Medical Center

Kyung Hee University Hospital at Gangdong

Seoul National University Hospital

Seoul National University Bundang Hospital

Samsung Medical Center

Konkuk University Medical Center

National Police Hospital

Seoul Veterans Hospital

hansol hospital

Kangdong Seoul Clinic

Jamsil Seoul Surgical Clinic

Song Do Colorectal Hospital

Yang Hospital

Daehang Hospital

Kangdong Sacred Heart Hospital

Investigators

Principal Investigator:	Suk-Kyun Yang, M.D.	Asan Medical Center

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Yang SK, Yun S, Kim JH, Park JY, Kim HY, Kim YH, Chang DK, Kim JS, Song IS, Park JB, Park ER, Kim KJ, Moon G, Yang SH. Epidemiology of inflammatory bowel disease in the Songpa-Kangdong district, Seoul, Korea, 1986-2005: a KASID study. Inflamm Bowel Dis. 2008 Apr;14(4):542-9.

Yang SK, Hong WS, Min YI, Kim HY, Yoo JY, Rhee PL, Rhee JC, Chang DK, Song IS, Jung SA, Park EB, Yoo HM, Lee DK, Kim YK. Incidence and prevalence of ulcerative colitis in the Songpa-Kangdong District, Seoul, Korea, 1986-1997. J Gastroenterol Hepatol. 2000 Sep;15(9):1037-42.

Responsible Party:	Suk-Kyun Yang, Professor, Asan Medical Center
ClinicalTrials.gov Identifier:	NCT01731665 History of Changes
Other Study ID Numbers:	2012-0634
First Posted:	November 22, 2012
Last Update Posted:	July 12, 2016
Last Verified:	July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by Suk-Kyun Yang, Asan Medical Center:

Crohn's disease; ulcerative colitis; epidemiology; Korea

Additional relevant MeSH terms:

Crohn Disease; Colitis; Ulcer; Colitis, Ulcerative; Intestinal Diseases; Inflammatory Bowel Diseases	Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Pathologic Processes