- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03445624
Abdominal Ultrasound With Doppler and Peripheral Hemogram in Assesment Inflammatory Bowel Disease
August 26, 2023 updated by: hyam fathy, Assiut University
assessment of inflammatory bowel disease patients in activity and remission by abdominal ultrasound examine non-invasive and in physiological condition by measuring the colon wall thickness in diagnosis and follow up the patient also including extra intestinal features such as the splanchnic vessels,mesentery and lymph nodes .
Doppler u.s can evaluate bowel wall vascularity In activity and remission .
peripheral hemogram in relationship to activity inflammatory bowel disease asses anemia ,increase monocyte and decrease mean platelet volume( MPV) .
also,the investigator will evaluate the outcome of different lines of treatment traditional and biologic therapy (response to treatment,times of activity and complications)
Study Overview
Detailed Description
the participants will follow up the patient for 1 year in the first visit
All patients in this study will be subjected to:
- Detailed history.
- Careful physical examination
laboratory investigation
- complete blood picture.
- liver function
- kidney function
- Iron profile(serum iron ,serum ferritin
- ESR (erythrocyte sedimentation rate )
g-CRP (C reactive protein) f-LDH (lactate dehydrogenase)
- Abdominal us(the colon wall thickness,lymph nodes,mass,other organs)
- Doppler us (mesenteric vessels)
- colonoscopy after 1 year of treatment follow up every 3 months by abdominal US and peripheral hemogram and last visit after 1 year colonoscopy and biopsy for assessment response to treatment
Study Type
Observational
Enrollment (Actual)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Assiut, Egypt
- Hyam Fathy
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 60 years (Child, Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
all patients diagnosed inflammatory bowel disease (ulcerative colitis and crohns disease) at age(15 -60)
Description
Inclusion Criteria
- patients diagnosed ulcerative colitis at age(15-60)
- patients diagnosed crohns disease at age(15-60)k
Exclusion criteria
- liver cirrhosis and portal hypertension
- spontaneous bacterial peritonitis
- Ischemic colitis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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patient on traditional therapy
Drug: steroid,5ASA , immuran for assesment the outcome of therapy in inflammatory bowel disease steroid(40- 60mg tablet),5ASA(pentasa 3-4gm tablet),azathioprin (immuran 100 mg tablet)
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follow up the patients who received this drugs for 1 year by abdominal ultrasound,peripheral hemogram and colonoscopy
Other Names:
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patient on infliximab
drug : infliximab (5mglkg intravenous)for the first dose,the second dose after 2 weeks the third dose after 6 weeks then every 2 months
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follow up the patients who received this drugs for 1 year by abdominal ultrasound,peripheral hemogram and colonoscopy
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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the role abdominal ultrasound in assessment inflammatory bowel disease
Time Frame: 2 year
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measure the thickness of the colon by abdominal ultrasound and doppler mesenteric vessels .more
than 4ml detect activity doppler mesenteric highly vascularity in activity
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2 year
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assesment inflammatory bowel disease by complete blood picture
Time Frame: 2year
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follow up haemoglobin level (less than 10 mg) indicate anemia which mean the patient uncontrolled monocyte( monocyte more than 12% of white blood cell count detect activity) Mean platelet volume less than 6 fl which decrease in activity inflammatory bowel disease
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2year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: ahmed ashmawy, Lecturer of Internal Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2018
Primary Completion (Actual)
February 1, 2021
Study Completion (Actual)
October 1, 2021
Study Registration Dates
First Submitted
January 9, 2018
First Submitted That Met QC Criteria
February 20, 2018
First Posted (Actual)
February 26, 2018
Study Record Updates
Last Update Posted (Actual)
August 29, 2023
Last Update Submitted That Met QC Criteria
August 26, 2023
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- assiut hospitals university
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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