A Comparative Study of Clinical, Endoscopic and Histopath... | NCT06371183

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

NCT06371183

Sponsor

Assiut University

Status

Not yet recruiting

Last Update Posted

Jul 16, 2024Actual

Enrollment

196Estimated

Phase

Not Applicable

Conditions

Role of Ileoscopy in Diagnosis of Colitis

Interventions

Colonoscope

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2024Estimated

Primary Completion Date

Aug 30, 2026Estimated

Completion Date

Aug 30, 2027Estimated

First Submitted Date

Apr 15, 2024

First Submission Date that Met QC Criteria

Apr 15, 2024

First Posted Date

Apr 17, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 14, 2024

Last Update Posted Date

Jul 16, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A Comparative study of clinical, endoscopic and histopathological features of colitis in children

Detailed Description

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

196Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with lower GI manifestations	Other	Patients with lower GI manifestations will undergo total colonoscopy with biopsy	Device: Colonoscope

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Colonoscope	Device	Endoscopy for lower GIT	Patients with lower GI manifestations

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Month

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Asmaa Omar, MD	Contact	01003337028		asmaaomar2749@gmail.com
Nagla Hassan Abufadan, Prof	Contact	0111 187 2237		nagla.ibrahim@med.au.edu.eg

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

I will share the IPD results

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D020685	Colonoscopes

Ancestor Terms

ID	Term
D020776	Endoscopes, Gastrointestinal
D019723	Endoscopes
D019719	Diagnostic Equipment
D004864	Equipment and Supplies

Browse Leaves

Not provided

Browse Branches

Not provided