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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2012 by Asan Medical Center
Sponsor:
Collaborators:
Kyung Hee University Gangdong Hospital
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
Information provided by (Responsible Party):
Suk-Kyun Yang, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01731665
First received: November 18, 2012
Last updated: November 27, 2012
Last verified: November 2012
  Purpose

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
Crohn's Disease
Ulcerative Colitis
Epidemiology
Korea

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Epidemiology of Inflammatory Bowel Disease in the Songpa-Kangdong District, Seoul, Korea.

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Incidence rate and prevalence rate of IBD [ Time Frame: 1986-2017 (up to 31 years) ] [ Designated as safety issue: No ]
    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:
  • Clinical features of patients with IBD [ Time Frame: 1986-2017 (up to 31 years) ] [ Designated as safety issue: No ]
    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.)


Estimated Enrollment: 2000
Study Start Date: December 2012
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01731665

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 Gangdong Hospital
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

Publications:
Responsible Party: Suk-Kyun Yang, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01731665     History of Changes
Other Study ID Numbers: 2012-0634
Study First Received: November 18, 2012
Last Updated: November 27, 2012
Health Authority: South Korea: Institutional Review Board

Keywords provided by Asan Medical Center:
Crohn's disease
ulcerative colitis
epidemiology
Korea

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Crohn Disease
Inflammatory Bowel Diseases
Intestinal Diseases
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014