NCT03436966

Brief Summary

Aim of the work: To evaluate the role of CT in diagnosis of IBD

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2018

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 19, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

February 20, 2018

Status Verified

February 1, 2018

Enrollment Period

11 months

First QC Date

February 13, 2018

Last Update Submit

February 17, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Diagnosis of inflammatory bowel disease by MSCT enterography

    detect the early complication of the disease: fistula, stricture, fibofatty changes by enterography

    baseline

Interventions

Positive enteric contrast, can, however, obscure IV contrast enhancement of the bowel wall. In addition, positive oral contrast agents opacify but do not always well distend the bowel. IV contrast is administered and images are acquired in the portal venous phase, which is optimized for visceral organ evaluation.

Eligibility Criteria

Age15 Years - 80 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

* Number of 30 Patients with inflammatory bowel disease will be included in the study. * CT scans are typically performed for IBD evaluation following administration of both oral and IV contrast to detect bowel wall abnormalities and abnormal enhancement\[6\] * Conventional CT uses positive enteral contrast agents, usually water soluble containing solutions, which increase the attenuation of the bowel lumen and of bowel wall abnormalities and extraluminal fluid collections.

You may qualify if:

  • Patient in the age group between 15\&40 and another age group between 50\&80 with inflammatory bowel disease.

You may not qualify if:

  • Patients with any general contraindication to Radiation of CT especially pregnant women.
  • Patients with any general contraindication to contrast, impaired renal function \& hypersensitivity.
  • Patients of the age group below 15 years old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Loftus EV Jr. Clinical epidemiology of inflammatory bowel disease: Incidence, prevalence, and environmental influences. Gastroenterology. 2004 May;126(6):1504-17. doi: 10.1053/j.gastro.2004.01.063.

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • shreef abd, prof

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

HMakarem am, residant

CONTACT

Mzidan z, Asst.prof

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

February 13, 2018

First Posted

February 19, 2018

Study Start

October 1, 2018

Primary Completion

September 1, 2019

Study Completion

October 1, 2019

Last Updated

February 20, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share