Inflammatory Bowel DiseasesNCT04952558
Delayed Diagnostic Time& Inflammatory Bowel Diseased Patients
An observational study of Inflammatory Bowel Diseases, run by Assiut University at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases
- How many people
- 700 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2021to 1 Mar 2022
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cross sectional observational study will be conducted among 700 patients of Egyptian inflammatory bowel diseased patients for different regions
Who may be able to join
- Egyptian inflammatory bowel diseased patients above the age of 18 years with definite diagnosis based on clinical ,endoscopic ,histological basis
- -
Who cannot join
- Inflammatory bowel diseased Patients below 18 years old
- -
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Bahaa Osman Taha
Asyut, 71515
BAHAA OS TAHA, MD, 0201015599135, Bahaa_osman99@aun.edu.eg
About this study
Official title: 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] 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
- Estimate time delay for diagnosis of Egyptian inflammatory bowel diseased patients
- compare the delay time for diagnosis of Egyptian inflammatory bowel diseased patients globally
Read the 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
- Estimate time delay for diagnosis of Egyptian inflammatory bowel diseased patients
- compare the delay time for diagnosis of Egyptian inflammatory bowel diseased patients globally
- studing risk factors that causing diagnostic delay among Egyptian inflammatory bowel diseased patients the time
- 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 :
- 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.
- 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.
- 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.
- 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.
- 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
- Keywords
- Lag time, inflammatory bowel disease
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
measure time delay for diagnosis of Egyptian inflammatory bowel diseased patients
duration in months from the first symptoms appearance till the definite diagnosis
Measured: 2 months
compare the delay time for diagnosis of Egyptian inflammatory bowel diseased patients globally
difference in months between global delay and Egyptian delay for diagnosis of inflammatory bowel disease
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start1 Jul 2021 (estimated)
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 700 participants (estimated)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bahaa osman taha, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04952558
- Sponsor's protocol ID
- ESIBD1989BAHAA
- Status last verified
- Jun 2021
- First submitted
- 28 Jun 2021
- Last updated
- 7 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Lag Time Among Egyptian Inflammatory Bowel Diseased Patients
- ClinicalTrials.gov ID
- NCT04952558
- Acronym / sponsor ID
- ESIBD1989BAHAA
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- Lag time, inflammatory bowel disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (estimated)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 7 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Estimate time delay for diagnosis of Egyptian inflammatory bowel diseased patients
- 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
- Estimate time delay for diagnosis of Egyptian inflammatory bowel diseased patients
- compare the delay time for diagnosis of Egyptian inflammatory bowel diseased patients globally
- studing risk factors that causing diagnostic delay among Egyptian inflammatory bowel diseased patients the time
- 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 :
- 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.
- 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.
- 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.
- 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.
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 4 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cross sectional observational study will be conducted among 700 patients of Egyptian inflammatory bowel diseased patients for different regions
Key inclusion criteria (2 listed)
- Egyptian inflammatory bowel diseased patients above the age of 18 years with definite diagnosis based on clinical ,endoscopic ,histological basis
- -
Key exclusion criteria (2 listed)
- Inflammatory bowel diseased Patients below 18 years old
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
measure time delay for diagnosis of Egyptian inflammatory bowel diseased patients
Time frame: 2 months
duration in months from the first symptoms appearance till the definite diagnosis
compare the delay time for diagnosis of Egyptian inflammatory bowel diseased patients globally
Time frame: 4 months
difference in months between global delay and Egyptian delay for diagnosis of inflammatory bowel disease
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact bahaa M taha, MD (0201015599135 ext. ASSIUT, bahaa_osman99@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measure time delay for diagnosis of Egyptian inflammatory bowel diseased patients (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2021.