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NCT Number: NCT01731665

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

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.

Recruiting

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.)

Study contacts

Contact information is provided by the study sponsor or research team.

Byong Duk Ye, M.D.

CONTACT

[email protected]

+82-2-3010-3181

Suk-Kyun Yang, M.D.

CONTACT

[email protected]

+82-2-3010-3901

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Collaborators

  • Daehang Hospital
  • Jamsil Seoul Surgical Clinic
  • Kangdong Sacred Heart Hospital
  • Kangdong Seoul Clinic
  • Konkuk University Medical Center
  • Kyung Hee University Hospital at Gangdong
  • National Police Hospital
  • Samsung Medical Center
  • Seoul National University Bundang Hospital
  • Seoul National University Hospital
  • Seoul Veterans Hospital
  • Song Do Colorectal Hospital
  • Yang Hospital
  • hansol hospital

Registry information

Important dates

Study start
2012
Primary completion
2029
Study completion
2029
First posted
Nov 22, 2012
Registry last updated
Jan 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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