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

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01731665
• Other study ID #: 2012-0634
• Status: Recruiting
• Start date: December 2012
• Est. completion date: June 2029

Study information

• Verified date: January 2021
• Source: Asan Medical Center
• Contact: Suk-Kyun Yang, M.D.
• Phone: +82-2-3010-3901
• Email: sky[@]amc.seoul.kr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: June 2029
• Est. primary completion date: June 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Crohn Disease
• Crohn's Disease
• Epidemiology
• Inflammatory Bowel Diseases
• Korea
• Ulcer
• Ulcerative Colitis

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (15)

Lead Sponsor	Collaborator
Asan Medical Center	Daehang Hospital, hansol 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

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence rate and prevalence rate of IBD	Annual incidence rate of Crohn's disease and ulcerative colitis; Prevalence rate of Crohn's disease and ulcerative colitis as of Dec 31, 2017.	1986-2017 (up to 31 years)
Secondary	Clinical features of patients with IBD	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.)	1986-2017 (up to 31 years)