Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04952558 |
| Other study ID # |
ESIBD1989BAHAA |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2021 |
| Est. completion date |
March 1, 2022 |
Study information
| Verified date |
June 2021 |
| Source |
Assiut University |
| Contact |
bahaa M taha, MD |
| Phone |
0201015599135 |
| Email |
bahaa_osman99[@]aun.edu.eg |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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
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.
