Intestinal ultrasound in Ulcerative Colitis - Clinical Trials Registry

Study Overview

Status

Not yet recruiting

Conditions

Ulcerative Colitis

Intervention / Treatment

Device: intestinal ultrasound

Detailed Description

Ultrasound examination is an easily accessible, non-invasive, radiation-free technique, and cheap imaging modality that is often chosen as the first diagnostic method in gastroenterology disease.

performance of bowel ultrasound use of two different probes: low-frequency convex probe (3.0-3.5 MHz) and high-frequency linear probe (5-17 MHz) .

Inflammatory bowel disease (IBD) is a chronic inflammatory disease of the gastrointestinal tract, which clinically contains Crohn's disease, ulcerative colitis, and other conditions. IBD is characterized by episodes of abdominal pain, diarrhea, bloody stools, weight loss, and the influx of neutrophils and macrophages that produce cytokines, proteolytic enzymes

Intestinal ultrasound has been shown to have high sensitivity and specificity in the detection or exclusion of intestinal inflammatory activity in IBD. advantages of intestinal ultrasound over other imaging modalities include non-invasiveness, rapid availability and low costs ,evaluation of bowel wall thickness, as well as stratification that reflects alterations in histopathology ulcerative colitis (UC). Visualization of the vascularization of the bowel using color Doppler sonography and, direct visualization of motility.

A study done : IUS is preferred for monitoring the disease course and for assessing short-term treatment response. Found that monitoring bowel wall thickening (BWT) alone has the potential to predict the therapeutic response.The primary therapeutic goal in UC is to induce and maintain long-term disease remission; however, there is no single treatment pathwayguidelines recommend the use of either conventional therapies (i.e., aminosalicylates ..etc)Or the use of biologic therapies ( infliximab.)

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Abanoub Melk
Phone Number: 01228261560
Email: abanoub.ayoub@med.aun.edu.eg

Study Contact Backup

Name: Magda Hasan, MD
Phone Number: 01066900939
Email: Magda_sh@yahoo.com

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Any patient above age of 18 years old and diagnosed to have UC and whom not responding to conventional medical therapy and eligible for biological therapy will be recruited in this study

Description

Inclusion Criteria:

Any patient above age of 18 years old and diagnosed to have UC and whom not responding to conventional medical therapy and eligible for biological therapy will be recruited in this study
- moderate to severe UC patients
- immunosuppressant or corticosteroid refractory disease
- those with intolerance or contraindication to conventional therapies are eligible to be treated with biological therapy

Exclusion Criteria:

Patients with UC who are under age of 18 years' old
Patients with UC who aren't eligible to biological therapy
patients with complication of UC(fistula , intestinal obstruction , intestinal perforation ,……)
Patient refuse to participate in the study.

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

Observational Models: Cohort
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the role of intestinal ultrasound in evaluation of the therapeutic response to biological therapy in patient with ulcerative colitis Time Frame: Baseline , 2 weeks , 6 weeks	All patients will be evaluated using intestinal ultrasound with special emphasis on intestinal wall thickness in mm as well as stratification normal or dirupted and Visualization of the vascularization (normal decrease or increased) of the bowel using color Doppler sonography also visualization of motility (normal , increased or decreaed) Findings of intestinal ultrasound will be compared regrading colonoscopic findings to evaluate the response to biological therapy through IUS	Baseline , 2 weeks , 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

January 1, 2023

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

March 12, 2024

Study Registration Dates

First Submitted

August 3, 2022

First Submitted That Met QC Criteria

October 31, 2022

First Posted (Actual)

November 7, 2022

Study Record Updates

Last Update Posted (Actual)