AzTrials
AzTrials

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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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
  • Bahaa Osman Taha

    Asyut, 71515

    BAHAA OS TAHA, MD, 0201015599135, Bahaa_osman99@aun.edu.eg

    Recruiting

Other trials in Egypt

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

  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
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

  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.
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 groups in NCT04952558
Study groupRoleWhat they receive
Cross sectional observational studyCross 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.

  1. 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

  2. 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.

  1. First posted7 Jul 2021
  2. Study start1 Jul 2021 (estimated)
  3. Primary completion1 Jan 2022 (estimated)
  4. Study completion1 Mar 2022 (estimated)

Resources

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
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in