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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03445624
Other study ID # assiut hospitals university
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2018
Est. completion date October 1, 2021

Study information

Verified date July 2020
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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)


Description:

the participants will follow up the patient for 1 year in the first visit All patients in this study will be subjected to: 1. Detailed history. 2. Careful physical examination 3. laboratory investigation 1. complete blood picture. 2. liver function 3. kidney function 4. Iron profile(serum iron ,serum ferritin 5. ESR (erythrocyte sedimentation rate ) g-CRP (C reactive protein) f-LDH (lactate dehydrogenase) 4. Abdominal us(the colon wall thickness,lymph nodes,mass,other organs) 5. Doppler us (mesenteric vessels) 6. 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


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date October 1, 2021
Est. primary completion date February 1, 2021
Accepts healthy volunteers No
Gender All
Age group 15 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Infliximab
follow up the patients who received this drugs for 1 year by abdominal ultrasound,peripheral hemogram and colonoscopy

Locations

Country Name City State
Egypt Hyam Fathy Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Other Assesment inflammatory bowel disease by complete blood picture 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 2year
Primary the role abdominal ultrasound in assessment inflammatory bowel disease measure the thickness of the colon by abdominal ultrasound and doppler mesenteric vessels .more than 4ml detect activity doppler mesenteric highly vascularity in activity 2 year
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