A Comparative Study of Clinical, Endoscopic and Histopathological Features of Colitis in Children

July 14, 2024 updated by: Asmaa Omar Mahmoud Said, Assiut University
A Comparative study of clinical, endoscopic and histopathological features of colitis in children

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

To find out the role of ileoscopy in diagnosis of colitis and compare clinical , endoscopic and histopathological manifestations of colitis

Study Type

Interventional

Enrollment (Estimated)

196

Phase

  • Not Applicable

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

Study Contact Backup

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

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 1. All patients diagnosed as colitis during the study period. 2. Age from 1 month to 18 years.

Exclusion Criteria:

  1. Patients with lower gastrointestinal manifestations and weren't diagnosed as colitis during colonoscope.
  2. Patients less than one month and more than 18 years.

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patients with lower GI manifestations
Patients with lower GI manifestations will undergo total colonoscopy with biopsy
Device: Colonoscope
Endoscopy for lower GIT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Is ileoscopy indicated for all children complaining of colitis on 196 patient
Time Frame: 2years
Biopsy from ileum will be taken to diagnose colitis
2years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To correlate clinical manifestations by colonoscopic picture
Time Frame: 2years
Some patients with lower GI manifestations,their colonoscopy is normal. So corolate clinical with biopsy
2years

Collaborators and Investigators

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

Sponsor

Assiut University

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 (Estimated)

September 1, 2024

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

August 30, 2027

Study Registration Dates

First Submitted

April 15, 2024

First Submitted That Met QC Criteria

April 15, 2024

First Posted (Actual)

April 17, 2024

Study Record Updates

Last Update Posted (Actual)

July 16, 2024

Last Update Submitted That Met QC Criteria

July 14, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AOMSaidB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

I will share the IPD results

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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