Abdominal Ultrasound With Doppler and Peripheral Hemogram in Assesment Inflammatory Bowel Disease

NCT03445624 | Completed DMC

• 1 other identifier: assiut hospitals university
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

• 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

Other Outcomes (1)

• Assesment inflammatory bowel disease by complete blood picture

  2year

Study Arms (2)

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)

Drug: Infliximab

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

Drug: Infliximab

Interventions

Infliximab DRUG

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

Also known as: steroid,immuran 5ASA

patient on infliximab; patient on traditional therapy

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

all patients diagnosed inflammatory bowel disease (ulcerative colitis and crohns disease) at age(15 -60)

You may qualify if:

• patients diagnosed ulcerative colitis at age(15-60)
• patients diagnosed crohns disease at age(15-60)k

You may not qualify if:

• liver cirrhosis and portal hypertension
• spontaneous bacterial peritonitis
• Ischemic colitis

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Hyam Fathy

Asyut, Egypt

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Infliximab; Steroids

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• ahmed ashmawy

  lecturer of internal medicine

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical professor

Study Record Dates

• First Submitted: January 9, 2018
• First Posted: February 26, 2018
• Study Start: July 1, 2018
• Primary Completion: February 1, 2021
• Study Completion: October 1, 2021
• Last Updated: August 29, 2023

Record last verified: 2020-07

Locations

EG (1)