Delayed Diagnostic Time& Inflammatory Bowel Diseased Patients

NCT ID: NCT04952558

Last Updated: 2021-07-07

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 700 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2022-03-01

Brief Summary

Introduction The incidence of inflammatory bowel disease [IBD] is increasing worldwide. Both Crohn's disease [CD] and ulcerative colitis [UC] are therefore becoming an important public health issue[1] The IBD is characterized by chronic intestinal inflammation, which can cause bowel damage and intestinal complications primarily depending on the duration and severity of the inflammation[2] The diagnosis of inflammatory bowel diseases (IBD) is often established following considerable delay due to nonspecific and inconsistent symptoms. In previous western studies, the delayed diagnosis was associated with poor outcome in patients with Crohn's disease (CD).[2] Timely diagnosis is not only important for the patients themselves but has also become a relevant public health issue due to the rising incidence of IBD worldwide[3] Patients and methods Cross sectional observational study will be conducted among 700 patients of Egyptian inflammatory bowel diseased patients for different regions Aim of the study

1. Estimate time delay for diagnosis of Egyptian inflammatory bowel diseased patients

2. compare the delay time for diagnosis of Egyptian inflammatory bowel diseased patients globally

Detailed Description

diagnostic Lag time among Egyptian inflammatory bowel diseased patients

Introduction The incidence of inflammatory bowel disease [IBD] is increasing worldwide. Both Crohn's disease [CD] and ulcerative colitis [UC] are therefore becoming an important public health issue[1] The IBD is characterized by chronic intestinal inflammation, which can cause bowel damage and intestinal complications primarily depending on the duration and severity of the inflammation[2] The diagnosis of inflammatory bowel diseases (IBD) is often established following considerable delay due to nonspecific and inconsistent symptoms. In previous western studies, the delayed diagnosis was associated with poor outcome in patients with Crohn's disease (CD).[2] Timely diagnosis is not only important for the patients themselves but has also become a relevant public health issue due to the rising incidence of IBD worldwide[3] Abdominal pain is the most prevalent initial chief complaint in patients with CD; however, it is also a common symptom of other digestive disorders, such as irritable bowel syndrome may the pain is not severe, it is easily regarded as trivial, and the diagnosis may be missed because the tests needed for the diagnosis of IBD are not performed. [4] A delayed diagnosis of CD may incur high medical cost in patients who develop aggressive disease that requires treatment with anti-TNFα agents[5] Aim of the study

1. Estimate time delay for diagnosis of Egyptian inflammatory bowel diseased patients

2. compare the delay time for diagnosis of Egyptian inflammatory bowel diseased patients globally

3. studing risk factors that causing diagnostic delay among Egyptian inflammatory bowel diseased patients the time

4. frequency of diagnosed complicated inflammatory bowel diseased as first time presentation

Patients and methods Cross sectional observational study will be conducted among 700 patients of Egyptian inflammatory bowel diseased patients for different regions

Inclusion criteria Egyptian inflammatory bowel diseased patients above the age of 18 years with definite diagnosis based on clinical ,endoscopic ,histological basis

Detailed history will be taken from all included patients focus on

• age ,sex , special habit ,residence .
• education level -socioeconomic status
• type of the inflammatory bowel disease
• lag time for reaching the proper diagnosis of inflammatory bowel disease which definite as time from the first symptoms presentation to reaching definite diagnosis
• symptoms that causing patients seeking medical advice
• number of Inflammatory bowel diseased patients referred for first time from surgeons
• number of patients have perianal symptoms
• number of patients have previous history of appendicectomy
• physicians numbers that visited by the patients to reaching the diagnosis
• ileal intubation at first time colonoscopy
• number of patients change their diagnosis from ulcerative colitis to Crohn's disease
• type of radiological assessment of the examined patients

Exclusion criteria Inflammatory bowel diseased Patients below 18 years old

Ethical consideration:

consent will be taken from all participating patients and must be approved by the ethical committee

References :

1. E. V. Loftus, "Clinical epidemiology of inflammatory bowel disease: Incidence, prevalence, and environmental influences," Gastroenterology, vol. 126, no. 6, pp. 1504-1517, 2004, doi: 10.1053/j.gastro.2004.01.063.

2. D. W. Lee et al., "Diagnostic delay in inflammatory bowel disease increases the risk of intestinal surgery," World J. Gastroenterol., vol. 23, no. 35, pp. 6474-6481, Sep. 2017, doi: 10.3748/wjg.v23.i35.6474.

3. S. R. Vavricka et al., "Systematic evaluation of risk factors for diagnostic delay in inflammatory bowel disease," Inflamm. Bowel Dis., vol. 18, no. 3, pp. 496-505, Mar. 2012, doi: 10.1002/ibd.21719.

4. G. Novacek et al., "Diagnostic delay in patients with inflammatory bowel disease in Austria," Wien. Klin. Wochenschr., vol. 131, no. 5-6, pp. 104-112, Mar. 2019, doi: 10.1007/s00508-019-1451-3.

5. L. Cantoro et al., "The Time Course of Diagnostic Delay in Inflammatory Bowel Disease Over the Last Sixty Years: An Italian Multicentre Study," J. Crohn's Colitis, vol. 11, no. 8, pp. 975-980, Aug. 2017, doi: 10.1093/ecco-jcc/jjx041.

Conditions

Inflammatory Bowel Diseases

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Cross sectional observational study

Cross sectional observational study will be conducted among 700 patients of Egyptian inflammatory bowel diseased patients for different regions

Detailed history will be taken from all included patients focus on

• age ,sex , special habit ,residence .
• education level -socioeconomic status
• type of the inflammatory bowel disease
• lag time for reaching the proper diagnosis of inflammatory bowel disease which definite as time from the first symptoms presentation to reaching definite diagnosis
• symptoms that causing patients seeking medical advice
• number of Inflammatory bowel diseased patients referred for first time from surgeons
• number of patients have perianal symptoms
• number of patients have previous history of appendicectomy

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

Egyptian inflammatory bowel diseased patients above the age of 18 years with definite diagnosis based on clinical ,endoscopic ,histological basis

-

Exclusion Criteria

Inflammatory bowel diseased Patients below 18 years old

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Bahaa osman taha

assistant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Bahaa Osman Taha

Asyut, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

bahaa M taha, MD

Role: CONTACT

bahaa_osman99@aun.edu.eg

0201015599135 ext. ASSIUT

Facility Contacts

BAHAA OS TAHA, MD

Role: primary

Bahaa_osman99@aun.edu.eg

0201015599135

Other Identifiers

ESIBD1989BAHAA

Identifier Type: -

Identifier Source: org_study_id