Epidemiology of Inflammatory Bowel Disease in the Songpa-Kangdong District, Seoul, Korea.
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ClinicalTrials.gov Identifier: NCT01731665 |
Recruitment Status
:
Recruiting
First Posted
: November 22, 2012
Last Update Posted
: July 12, 2016
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Condition or disease |
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Crohn's Disease Ulcerative Colitis Epidemiology Korea |
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 |
Group/Cohort |
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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.
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- Incidence rate and prevalence rate of IBD [ Time Frame: 1986-2017 (up to 31 years) ]
- Annual incidence rate of Crohn's disease and ulcerative colitis
- Prevalence rate of Crohn's disease and ulcerative colitis as of Dec 31, 2017.
- Clinical features of patients with IBD [ Time Frame: 1986-2017 (up to 31 years) ]
- Clinical characteristics of patients newly diagnosed with Crohn's disease or ulcerative colitis: gender, presenting symptoms, duration between symptoms to diagnosis, and phenotypes, etc.
- 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
- Treatment modalities of IBD and their trends: use of medication (5-ASA, corticosteroids, immunomodulators, and biologic agents, etc.)

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- Definite cases of CD and UC
Patients are diagnosed with CD if they meet at least 2 of the following criteria:
- clinical history of abdominal pain, weight loss, malaise, diarrhea, and/or rectal bleeding
- endoscopic findings of mucosal cobblestoning, linear ulceration, skip areas, or perianal disease
- radiologic findings of stricture, fistula, mucosal cobblestoning, or ulceration
- macroscopic appearance of bowel wall induration, mesenteric lymphadenopathy, and "creeping fat" at laparotomy
- 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
- a typical history of diarrhea or blood and pus or both in the stool for longer than 4 weeks
- 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
- characteristic histopathological signs of inflammation on biopsy
Exclusion Criteria:
- IBD unclassified
- Ethnic groups other than Korean

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01731665
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 |
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. |
Principal Investigator: | Suk-Kyun Yang, M.D. | Asan Medical Center |
Publications:
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 Key Record Dates |
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 |